List Of ARV Pharmaceutical Products classified according to the Global Fund Quality Assurance Policy

Edition: Version 163 - 14 July 2021

The list is an overview of pharmaceutical products subject to the Global Fund Quality Assurance Policy that are listed in National and/or WHO standard treatment guidelines and classified according to the various options (A, B, and ERP reviewed) defined in the Global Fund Quality Assurance Policy (July 2009, amended in December 2010). The list is developed as a tool to assist Principal Recipients (PR) of Global Fund grants to identify the status of finished pharmaceutical products according to the Global Fund Quality Assurance Policy.

The pharmaceutical products are classified based on the following information

A classified product - Listed on WHO prequalification list; B classified product - Stringent NDRA Registration letter/Marketing Authorization; ERP reviewed product- Permitted for time-limited procurement based on advice by the Expert Review Panel (ERP);

Please note that the list is not an exhaustive list. A PR can procure product(s) not listed in the current list as long as PR demonstrates that the product

Expert Review Panel (ERP): Expert Review Panel is an independent technical body composed of external technical experts, hosted by WHO Department of Essential Medicines and Pharmaceutical Policies, to review the potential risks/benefits associated with the use of FPPs that are not yet WHO-prequalified or SRA-authorized and to advise the Global Fund in its decision on whether to allow grant funds to be used to procure FPP. ERP reviewed products can be procured for a limited time (maximum 12 months). However, under certain circumstances, it is possible to extend the recommendation period. Contracts to supplier/manufacturer for an ERP reviewed products should not be longer than the validity period of the recommendation of that product. For detail information on ERP process and Quality Assurance information, please look at https://www.theglobalfund.org/en/sourcing-management/quality-assurance/.

Procurement of ERP Reviewed Products: Principal Recipients (PRs) must inform the concerned Fund Portfolio Manager (FPM) at the Global Fund in writing by filling the “Notification Form” ( available on website) if they intend to procure ERP-reviewed product(s). The Global Fund Secretariat will review the notification request and upon issuing a “ no objection” letter to the PR for the requested selection, procurement can only proceed.

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 1/52 Important Notes This List may be used by Principal Recipients of Global Fund grants when considering options with respect to procurement of pharmaceutical products pharmaceutical products subject to the Global Fund Quality Assurance Policy. The list aims at providing countries with information that will assist them in their procurement options. Please note that the list is not designed to be a basis for countries to select medicines to be included in their National Treatment Guidelines or to replace any applicable and legally required procurement processes. The Global Fund requires its grant recipients to comply with applicable procurement laws and provides the list only for the identification of products/manufacturers that comply with the Global Fund’s quality assurance policy. It is important to note that there is no strict requirement to procure according to the list, as long as the Principal Recipients can ensure that the product selected is compliant with the Quality Assurance policy criteria. Furthermore, the Principal Recipient should not rely solely on the information provided in the list but should obtain evidence of products compliance with the Quality Assurance policy. For the above reasons, we strongly encourage users to ensure they are using the most recent version on our website when conducting procurement.

The Lists will be updated regularly based on evidence received by the Global Fund. Interested parties are invited to supply information and evidence of products meeting the policy criteria on an ongoing basis. For the above reasons, we strongly encourage users to ensure they are using the most recent version on our website when conducting procurement.

According to the Global Fund QA policy, if there are two or more A or B classified manufacturers available for any given product AND the product is available from these manufacturers (available-means that the manufacturer can supply the selected product within 90 days after receiving the Purchase Order), then such product must be procured from A or B classified product manufacturers. The PR must notify by writing to the Global Fund Secretariat (Fund Portfolio Manager) and recieve the "No Objection" letter from GF secretariat before procuring any products complying with option " ERP Reviewed".

For ease of reference, each "product" has been identified in this list with a unique "Product reference number" (Column A). Please see examples below.

Several different dosage forms may be grouped under the same Product Reference Number and therefore will be considered the same type of products when identifying the number of available manufacturers for the application of this policy. These products share the same dosing protocol, target the same population, and there are no fundamental differences among them. For example, within solid forms, some capsules will have same reference number as tablets while within liquids, oral solution and suspension are grouped together.Similarly, the entero coated tablet or dispersible tablet will not share the same reference number as non entero coated or dispersible tablets.

Produc WHO Pre- International Supplier/Manufacturer Global Fund t Strength Dosage form qualified/ Manufacturing site* Country Material Pack Non-proprietary name * QA Standard Ref.No SRA

XYZ 50mg Tablet "Pharma Company A - B Yes "Pharmaville" Country A HDPE bottle 60 16 A" 100mg Tablet "Pharma Company A - B Yes "Pharmaville" Country B HDPE bottle 60 17 B"

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 2/52 The example above shows 2 different variants of the same medicine. Because the strength is different, it is considered 2 different products (there are two different reference numbers 16 and 17). If the strength had been the same but the dosage form had been different (i.e. tablet and liquid) it would also have been considered two different "products".

Produc WHO Pre- International Supplier/Manufacturer Global Fund t Strength Dosage form qualified/ Manufacturing site* Country Packaging Non-proprietary name * QA Standard Ref.No SRA

ABC 150mg Tablet "Pharma Company A - B Yes "Pharmaville" Country A Blister, 10, 60 25 A" HDPE bottle Capsules "Pharma Company A - B Yes "Pharmaville" Country B HDPE 60, 10 B" Bottle, In this second example both products have same reference number (25) because both manufacturers are supplying the same strength and the dosage forms are considered similar as per explanation above. * See below Disclaimer:

The Global Fund does not endorse or warrant the fitness of any product on the List for a particular purpose, including in regard of its safety and/or efficacy in the treatment of HIV/AIDS, HCV,tuberculosis or malaria. In addition, the Global Fund assumes no responsibility for any misstatement or omission from the list and directs Principal Recipients of Global Fund grants to conduct their own independent confirmation that the information on a given product on the list is accurate before relying on it to make a purchase order for that product, and to ensure that any purchase is in compliance with all the requirements of the Global Fund’s quality assurance policy. The Global Fund does not warrant or represent that the products listed have obtained regulatory approval for use of treatment of any disease in any particular country of the world, or that their use is otherwise in accordance with the national laws and regulations of any country, including, but not limited to, intellectual property laws. The Global Fund disclaims any and all liability and responsibility for any injury, death, damage or loss of any kind whatsoever that may arise as a result of, or in connection with the procurement, distribution and use of any product included in the list.

* As from version 137, please note that we consider under

Supplier / Manufacturer : Marketing authorization/ product authorization or license holder

Manufacturing Site: The Site responsible for the release of the FPP

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 3/52 List of A or B products:

If there are two or more ‘A’ or ‘ B” products available, then the product must be procured from one of the A or B products. Note: if the product intended for selection is not listed in this list , please refer to the List of ERP ( Expert Review Panel) Reviewed Products which are permitted for time limited procurement:

WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA 1 Abacavir 20 mg / ml Oral solution ViiV HealthCare A Yes Mississauga, Ontario Canada HDPE bottle 240ml Unit III, Survey No. 313 &314 Bachupally, Oral Aurobindo Pharma Abacavir 20 mg / ml B Yes Quthubullapur India HDPE Bottle 240ml Solution Ltd Mandal Hyderabad, Andhra Pradesh Dispersible A-33, MIDC 2 Abacavir (as Sulfate) 60 mg Cipla Ltd. A -B Yes India HDPE Bottle 60 Tablet Patalganga Mylan Laboratories Sinnar, Nashik, Abacavir (as Sulfate) 60 mg Tablet A -B Yes India HDPE 60 Ltd Maharashtra

Micro Labs Ltd, Phase III & Phase IV, Plot Dispersible Abacavir (as Sulfate) 60 mg Microlabs Ltd A HA674 No. S-155 to S-159 & India HDPE 60 Tablet N1 Verna Industrial Estate, Verna, Goa

A-23, MIDC HDPE 3 Abacavir 300 mg Tablet Cipla Ltd. A - B Yes India 60 Patalganga Bottle, Glaxo Operations UK, Ltd, Ware, Herthfordshire, UK; Abacavir 300 mg Tablet ViiV HealthCare A - B Yes UK Blister 60 GSK, Poznan (packaging and release), Poland

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 4/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Sinnar,Nashik, Maharashtra / Mylan Laboratories Limited, Plot No.11, 12 & 13, Indore Special HDPE Mylan Laboratories 60; Abacavir 300 mg Tablet A - B Yes Economic Zone, India Bottle; Ltd 6*10 Pharma Zone, Phase - Blister II, Sector - III, Pithampur – 454775 Dist. Dhar, Madhya Pradesh. Sun HDPE Paonta Sahib, 60; Abacavir 300 mg Tablet Pharmaceutical A Yes India Bottle; Himachal Pradesh 6*10 Industries Ltd Blister

36/7, HDPE Film coated Strides Arcolab Suragajakkanahalli 60; Abacavir (as Sulfate) 300 mg A-B Yes India Bottle; Tablet Limited Indlavadi cross Anekal 6*10 Blister Taluk Bangalore

Unit III 22 - 110, Industrial HDPE 60, 100, development Area, Bottle; Abacavir 300 mg Tablet Hetero labs limited A-B Yes India 500; Jeedimetla, Blister Film 10 Hyderabad -500 055 Package Andhra Pradesh,

Unit III, Survey No 313 Bachyupally, Quthubullapur Aurobindo Pharma Mandal Hyderabad, HDPE Abacavir 300 mg Tablet B Yes India 60 Ltd Andhra Pradesh Bottle; Unit-VII (SEZ), Mahaboob Nagar (DT), Andhra Pradesh

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 5/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA

Plot No. S-155 to S- ANDA 159 & N1, Phase III & Blister, Abacavir 300 mg Tablet Microlabs Ltd B 206725 IV , Verna Industrial India 10, 60 HDPE Bottle 22/12/17 Estate, Verna Salcette, Goa -403 722

Laurus Labs Limited, Plot No:19, 20 & 21, Western Sector, APSEZ, Abacavir + Dolutegravir Laurus ANDA HDPE 600+50+300 Tablet B Atchutapuram India 30 Lamivudine Laboratories Ltd 210899 Bottle; Mandal, Visakhapatnam- District-531011, Andhra Pradesh

Waluj, Aurangabad, Maharashtra; Plot No 11, 12 & 13, Indore Tablets for Special Economic Mylan Laboratories 6 Abacavir + Lamivudine 120 mg / 60 mg Oral B Yes Zone, Pharma Zone, India HDPE bottle 30,60, 2000 Ltd Suspension Phase II, Sector III, Pithampur, District Dhar, Madya Pradesh, 454 775, India

Plot No A – 33, A – 2 HA662 (Unit – I), MIDC, Abacavir (as Sulfate) + 120 mg / 60 mg Disp. Tablet Cipla Ltd. A-B NDA Patalganga District India HDPE Bottle 30, 60 Lamivudine 208775 Raigad, Maharashtra, 410 220

Unit - III Survey No. 313 & 314, Bachupally, HDPE 600 mg + 300 Aurobindo Pharma 30; 7 Abacavir + Lamivudine Tablet B Yes Quthubullapur India Bottle; mg Ltd 10 Mandal Hyderabad, Blister Andhra Pradesh

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 6/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Ware,Hertfordshire; 30 HDPE Bottle Aranda de Duero, 600 mg + 300 Tablet Film Glaxo SmithKline UK, Spain, Abacavir + Lamivudine B Yes Burgos; mg coated Ltd. USA Research Triangle 30 Blister Park, NC A-33, MIDC HDPE Abacavir Sulfate+ 600 mg + 300 30; Tablet Cipla Ltd. B Yes Patalganga India Bottle; Lamivudine mg 3*10 Cipla Goa Unit 7 Blister 600 mg + 300 Mylan Laboratories Sinnar,Nashik, Abacavir + Lamivudine Tablet A-B Yes India HDPE Bottle 28; 30 mg Ltd Maharashtra; H277 Hetero Labs Limited, Unit-V SEZ Unit I 600 mg + 300 HDPE Bottle 30 Abacavir + Lamivudine Tablet Hetero labs limited A-B HA657 Survey No. 439, 440, India mg Blister 10's x 10 441 & 458 Mahaboob Nagar. Glaxo Operations UK Limited, Priory Street, Ware, Hertfordshire, SG12 0DJ, United Kingdom of United Great Britain and Northern Child Kingdom of Ireland resistant 600 mg + 300 GlaxoSmithKline Great Britain Abacavir + Lamivudine Tablet ViiV Healthcare UK A HA706 blister, 1x1;10x3 mg Pharmaceuticals S. A. ul., and Limited PVC/PVdC- Grunwaldzka 189, 60-332 Northern Alu/Paper Poznan, Poland Ireland Glaxo Wellcome SA, Avenue de Extremadura 3, Aranda de Duero, Burgos, Spain

Village Ganguwala, Sun 600 mg + 300 Tablet, Film- Paonta Sahib, District Bottle, Abacavir + Lamivudine Pharmaceutical A HA698 India 30x1, 90x1 mg coated Sirmour, Himanchal HDPE Industries Ltd Pradesh, 173 025

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 7/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Macleods Macleods Pharmaceuticals Pharmaceuticals Ltd, Ltd, 304 Atlanta Block No. N2, Village Bottle Abacavir (as Sulfate) + 600 mg + 300 Tablet, Film- Arcade, Marol Theda, P.O. Lodhi 30x1, Blister A HA740 India HDPE, Lamivudine mg coated Church Road, Majra, Tehsil Baddi, of 6x10 Blister Andheri (East), District Solan, Mumbai, 400 059, Himachal Pradesh, 174 India 101, India Abacavir (as Sulfate)+ 60 mg + 30 mg + Mylan Laboratories Sinnar,Nashik, 8 Lamivudine + Tablet A Yes India HDPE 60 60 mg Ltd Maharashtra Zidovudine Sun Abacavir + Lamivudine + 300 mg + 150 mg Paonta Sahib, 9 Tablet Pharmaceutical A Yes India HDPE bottle 60 Zidovudine + 300 mg Himachal Pradesh Industries Ltd Glaxo Operations UK, Ltd, Ware, Abacavir + Lamivudine + 300 mg + 150 mg Hertfordshire, UK; HDPE Botte 60; Tablet ViiV HealthCare A - B Yes UK Zidovudine + 300 mg GSK, Poznan Blister, 40; 60 (packaging and release), Poland Abacavir (as Sulfate)+ 300 mg + 150 mg Mylan Laboratories Sinnar,Nashik, Lamivudine + Tablet A-B Yes India HDPE Bottle 60 + 300 mg Ltd Maharashtra Zidovudine Bristol-Myers Bottle 11 Atazanavir 50 mg / 1.5g Oral powder B Yes Hounslow UK 180g Squibb (HDPE) Bottle Hard Bristol-Myers 60, 12 Atazanavir 100 mg B Yes Hounslow UK (HDPE) Capsule Squibb 60 Blister (alu) Emcure HDPE Atazanavir 100 mg Capsule Pharmaceuticals B Yes Hinjwadi, Pune India 60; bottle; Limited Unit-VII (SEZ), 60,500 Aurobindo Pharma HDPE bottle Atazanavir 100 mg Capsule B Yes Mahaboob Nagar India Ltd Blister (DT), Andhra Pradesh 10

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 8/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Evansville, Indianna, Bristol-Myers Mount Vernon, 13 Atazanavir 150 mg Capsule A Yes USA HDPE bottle 60 Squibb Indianna (primary packaging) Bottle Capsule Bristol-Myers 60 Atazanavir 150 mg B Yes Hounslow UK (HDPE) Hard Squibb 60 Blister (alu) Emcure Atazanavir 150 mg Capsule Pharmaceuticals B Yes Hinjwadi, Pune India HDPE bottle 60 Limited Elizabeth (Pty) Ltd, Corner Fairclough and Aspen Pharmacare ANDA Atazanavir 150 mg Capsule B Gibaud Roads, South Africa HDPE bottle 60 Limited 091641 Korsten, Port Elizabeth, 6020

Sinnar, Nashik District, Maharashtra, Mylan Laboratories India; Atazanavir ( as Sulfate) 150 mg Capsule A -B Yes India HDPE Bottle 30, 100 Ltd Waluj, Aurangabad, Maharashtra, India

Unit-VII (SEZ), Aurobindo Pharma HDPE bottle 60,180, 500 Atazanavir ( as Sulfate) 150 mg Capsule B Yes Mahaboob Nagar India Ltd Blister 10 (DT), Andhra Pradesh Bottle Capsule Bristol-Myers 60, 14 Atazanavir 200 mg B Yes Hounslow UK (HDPE) Hard Squibb 60 Blister (alu) Emcure HDPE Atazanavir 200 mg Capsule Pharmaceuticals B Yes Hinjwadi, Pune India 60; bottle; Limited Unit-VII (SEZ), Aurobindo Pharma HDPE bottle 60,180, 500 Atazanavir 200 mg Capsule B Yes Mahaboob Nagar India Ltd Blister 10 (DT), Andhra Pradesh

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 9/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Elizabeth (Pty) Ltd, Corner Fairclough and Aspen Pharmacare ANDA Atazanavir 200 mg Capsule B Gibaud Roads, South Africa HDPE bottle 60 Limited 091641 Korsten, Port Elizabeth, 6020 Bristol-Myers 15 Atazanavir ( as Sulfate) 300 mg Capsule B Yes Evansville, Indiana, USA HDPE Bottle 30 Squibb Emcure Atazanavir ( as Sulfate) 300 mg Capsule Pharmaceuticals B Yes Hinjwadi, Pune India HDPE Bottle 30 Limited

Sinnar, Nashik District, Maharashtra, Mylan Laboratories India; Atazanavir ( as Sulfate) 300 mg Capsule A- B Yes India HDPE Bottle 30, 100 Ltd Waluj, Aurangabad, Maharashtra, India

Unit-VII (SEZ), 30, 90,500 Aurobindo Pharma HDPE bottle Atazanavir ( as Sulfate) 300 mg Capsule B Yes Mahaboob Nagar India Ltd Blister (DT), Andhra Pradesh 10

PLIVA Croatia Ltd., Prilaz baruna Filipovica 25, 10000 Zagreb; TEVA PHARMA S.L.U., C/C, n. 4, Poligono Industrial Malpica, 50016 Zaragoza; Teva Operations Poland Sp. z.o.o, Croatia, Spain, ul. Mogilska 80. 31-546, Krakow; Poland, TEVA Pharmaceutical Works, Germany, Private Limited Company, Pallagi Hungary, TEVA út 13, 4042 Debrecen; Merckle GmbH, Ludwig- Merckle- United Atazanavir ( as Sulfate) 300 mg Capsule Pharmaceutical A HA750 Kingdom of HDPE Bottle 30 Israel Ltd Straße 3, 89143 Blaubeuren; Merckle GmbH, Graf-Arco-Str. 3, Great Britain 89079 Ulm; and Northern TEVA UK Ltd, Brampton Road, Ireland, Hampden Park, Eastbourne, East Sussex, BN22 9AG; Netherlands MPF B.V., 13 Appelhof, Oudehaske, 8465; MPF B.V., Neptunus 12, 8448 CN HEERENVEEN TjoaPack Netherlands B.V., Nieuwe Atazanavir (sulfate)+ Mylan Laboratories Sinnar,Nashik, 16 300mg + 100mg Tablet A-B Yes India HDPE Bottle 30, 90, 120 Ritonavir Ltd Maharashtra

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 10/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Emcure Atazanavir Tablet 300mg+100mg Pharmaceuticals B Yes Hinjwadi, Pune India HDPE Bottle 30 (sulfate)+Ritonavir (FDC) Limited Cipla, Unit 2, Plot A- 42 MIDC Industrial Bottle HDPE Atazanavir 30x1; 300mg+100mg Tablet Cipla Ltd. A HA632 Area, Patalganga, India Alu/Alu (sulfate)/Ritonavir 10x3 Raigad District, Blister Maharashtra

Cartons containing 5 blister packs (consisting of [Atazanavir Sulfate+ [300 mg / 100 PVC/Aclar film and co-packaged Mylan Laboratories Sinnar, Nashik District coated aluminum 17 Ritonavir] +[Lamivudine mg] +[150 mg / B Yes India PVC blister foil), each containing Tablets Ltd 422 113, Maharashtra two 1-day cards, for a and Zidovudine] 300 mg] 10 day supply. Three cartons are further packaged together for a 30 day supply Mylan Laboratories Ltd F-4, F-12, Malegaon Mylan Laboratories M.I.D.C, 100; 500; 20 Darunavir 75mg Tablets B Yes India HDPE Bottle Ltd Sinnar, Nashik – 480 422113, Maharashtra state, India. Janssen Ortho LLC, Gurabo, Puerto Rico, Janssen Infectious United States Diseases - (Manufacturing and Darunavir (as 75 mg Tablets Diagnostics BVBA/ A-B Yes release testing); Puerto Rico HDPE Bottle 480 Ethanolate) Pharmacare South Janssen-Cilag SpA, Africa Latina, Italy (Testing and final QC release and packaging) Plot No. 15B, Phase 1 Darunavir (as A, Verna Industrial 75 mg Tablets Lupin Limited B Yes India HDPE Bottle 480 Ethanolate) Area, Verna, Salcette Goa - 403722

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 11/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA (Unit II), MIDC, Darunavir (as ANDA 21 150 mg Tablets Cipla B Patalganga India HDPE Bottle 480 Ethanolate) 207189

Mylan Laboratories Ltd F-4, F-12, Malegaon Mylan Laboratories M.I.D.C, Darunavir 150mg Tablets B Yes India HDPE Bottle 240; 300 Ltd Sinnar, Nashik – 422113, Maharashtra state, India. Janssen Ortho LLC, Gurabo, Puerto Rico, Janssen Infectious United States Diseases - (Manufacturing and Darunavir (as 150 mg Tablets Diagnostics BVBA/ A-B Yes release testing); Puerto Rico HDPE Bottle 240 Ethanolate) Pharmacare South Janssen-Cilag SpA, Africa Latina, Italy (Testing and final QC release and packaging) Plot No. 15B, Phase 1 Darunavir (as A, Verna Industrial 150 mg Tablets Lupin Limited B Yes India HDPE Bottle 240 Ethanolate) Area, Verna, Salcette Goa - 403722

Plot No. S-155 to S- ANDA 159 & N1, Phase III & Darunavir (as 150 mg Tablets Micro Labs Ltd, B 210187 IV , Verna Industrial India HDPE Bottle 60,120,240 Ethanolate) 14/12/20 Estate, Verna Salcette, Goa -403 722

Mylan Laboratories Ltd F-4, F-12, Malegaon Mylan Laboratories M.I.D.C, Darunavir 300mg Tablets B Yes India HDPE Bottle 120; 360 Ltd Sinnar, Nashik – 422113, Maharashtra state, India.

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 12/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Plot No. 15B, Phase 1 Darunavir (as A, Verna Industrial 300 mg Tablets Lupin Limited B Yes India HDPE Bottle 120 Ethanolate) Area, Verna, Salcette Goa - 403722 Mylan Laboratories Ltd F-4, F-12, Malegaon Mylan Laboratories M.I.D.C, 60; 180; 22 Darunavir 400mg Tablets B Yes India HDPE Bottle Ltd Sinnar, Nashik – 360 422113, Maharashtra state, India. (Unit-2), Plot No:19, 20 & 21, Western Sector, APSEZ, Tablet, Film- Laurus Labs Darunavir 400mg A HA709 Atchutapuram India HDPE Bottle 60 coated Limited Mandal,Visakhapatna m-District, Andhra Pradesh, 531011

Janssen Infectious Diseases - Jansen Ortho LLc, Darunavir 400 mg Tablets Diagnostics BVBA/ B Yes Puerto Rico HDPE Bottle 60 Gurabo Pharmacare South Africa

Hetero Labs Darunavir 400mg Tablet B Yes UNIT-III, Hyderabad India HDPE Bottle 60 limited HA627 (Unit II), MIDC, Darunavir (as 400mg Tablet Cipla A-B ANDA Patalganga India HDPE Bottle 60 Ethanolate) 207189 Plot No. 15B, Phase 1 Darunavir (as A, Verna Industrial 400mg Tablet Lupin Limited B Yes India HDPE Bottle 60 Ethanolate) Area, Verna, Salcette Goa - 403722

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 13/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA

Plot No. S-155 to S- ANDA 159 & N1, Phase III & Darunavir (as 400mg Tablet Micro Labs Ltd, B 210187 IV , Verna Industrial India HDPE Bottle 60 Ethanolate) 14/12/20 Estate, Verna Salcette, Goa -403 722

Janssen Infectious Diseases - Jansen Ortho LLc, Darunavir 600 mg Tablets Diagnostics BVBA/ B Yes Puerto Rico HDPE Bottle 60 Gurabo Pharmacare South Africa

(Unit-2), Plot No:19, 20 & 21, Western Sector, APSEZ, Tablet, Film- Laurus Labs Darunavir 600 mg A HA710 Atchutapuram India HDPE Bottle 60 coated Limited Mandal,Visakhapatna m-District, Andhra Pradesh, 531011 Janssen Ortho LLC, Gurabo, Puerto Rico, USA (manufacturing and release testing); Janssen Infectious Janssen-Cilag SpA, Diseases - Latina, Italy Darunavir 600 mg Tablets Diagnostics BVBA/ A Yes USA HDPE Bottle 60 (packaging, testing Pharmacare South and QC release); Africa Pharmacare Limited, Korsten, Port Elizabeth, South Africa (QC release) Hetero Labs Darunavir 600mg Tablet B Yes UNIT-III, Hyderabad India HDPE Bottle 60 limited

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 14/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Manufacturer LEK farmacevtska družba d.d. Verovškova 57, 1526 60x1 unit Ljubljana, Slovenia Aluminium- dose blister or PVC/PE/PV 10, 30, 60, Salutas Pharma Slovenia DC Film coated 90, 120 Darunavir 600 mg Sandoz Ltd, UK B Yes GmbH, Otto-von- Germany perforated Tablet 60, 120 Guericke-Allee 1, Cyprus blisters (2x60), 180 Sachsen-Anhalt, 39179 HDPE (3x60), 240 Barleben, Germany bottles (4x60) or Remedica Ltd, Aharnon Street, Limassol Industrial

a, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia TAD Pharma GmbH, Heinz- Lohmann - Straβe 5, 27472 30 (1x30); Cuxhaven, Germany Slovenia, Film coated Krka, d.d., Novo Prestige Promotion Bottle, 60 (2x30), Darunavir 600 mg A HA733 Germany, Tablet mesto Verkaufsförderung & HDPE 90 (3x30), Werbeservice GmbH, Lindigstraße Greece 6, 63801 Kleinostheim, Germany 180 (6x30) (Additional secondary packaging) RAFARM S A, Thesi Pousi-Xatzi Agiou Louka, Paiania Attiki TK 19002, TΘ 37, Greece

HA628 (Unit II), MIDC, Darunavir (as 600mg Tablet Cipla A-B ANDA Patalganga India HDPE Bottle 60 Ethanolate) 207189 Plot No. 15B, Phase 1 Darunavir (as A, Verna Industrial 600mg Tablet Lupin Limited B Yes India HDPE Bottle 60 Ethanolate) Area, Verna, Salcette Goa - 403722

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 15/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA FDF-Unit-2, Aurangabad site, (Plot No. H-12 and H- 13), Darunavir (as Mylan Laboratories HDPE 600mg Tablet A HA685 MIDC, Waluj India 60 Ethanolate) Ltd Container Industrial Area Aurangabad-431136 Maharashtra

Plot No. S-155 to S- ANDA 159 & N1, Phase III & Darunavir (as 600mg Tablet Micro Labs Ltd, B 210187 IV , Verna Industrial India HDPE Bottle 60 Ethanolate) 14/12/20 Estate, Verna Salcette, Goa -403 722

(Unit-2), Plot No:19, 20 & 21, Western Sector, APSEZ, Tablet, Film- Laurus Labs Darunavir 800 mg A HA711 Atchutapuram India HDPE Bottle 30 coated Limited Mandal,Visakhapatna m-District, Andhra Pradesh, 531011 Plot No. 15B, Phase 1 Darunavir (as A, Verna Industrial 800mg Tablet Lupin Limited B Yes India HDPE Bottle 30 & 90 Ethanolate) Area, Verna, Salcette Goa - 403722

Unit 2, Plot A-42 MIDC Industrial Area, Darunavir (as 800mg Tablet Cipla A HA664 Patalganga, Raigad India HDPE Bottle 30 Ethanolate) District, Maharashtra, 410 220

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 16/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA FDF-Unit-2, Aurangabad site, (Plot No. H-12 and H- Darunavir (as Mylan Laboratories 13), HDPE 800mg Tablet A HA683 India 30 Ethanolate) Ltd MIDC, Waluj Container Industrial Area Aurangabad-431136 Maharashtra

Hetero Labs Ltd, Hetero Corporate, 7- Hetero Labs Ltd, Unit 2-A2, Industrial III, Plot No 22-110 Darunavir (as Estates, Sanath IDA, Jeedimetla, 30x1, 400mg/50mg Tablet A HA719 India HDPE Bottle Ethanolate) / Ritonavir Nagar, Hyderabad, Hyderabad, 60x1,120x1 Ranga Reddy Telangana, 500 055, District, Telangana, India 500 018, India

Glaxo Operations UK Limited, Priory Street, Ware, Hertfordshire, SG12 0DJ, United ViiV Healthcare Kingdom of Great BV, Van Asch van Dolutegravir (as sodium Britain and Northern 5mg Disp. Tablet Wijckstraat 55H, A HA768 India HDPE Bottle 60x1 salt) Ireland; Amersfoort, 3811 Glaxo Wellcome SA, LP, Netherlands Avenue de Extremadura 3, Aranda de Duero, Burgos, Spain

Plot No.11, 12 & 13, Indore Special Economic Zone, Tablet for Dolutegravir (as sodium Mylan Laboratories NDA Pharma Zone, Phase - 10mg Oral B India HDPE Bottle 30,60,90 salt) Ltd 214521 II, Sector - III, Suspension Pithampur – 454775 Dist. Dhar, Madhya Pradesh.

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 17/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Glaxo Operations UK Ltd, Hertfordshire (manufacturing and Dolutegravir (as sodium Tablets, Film- quality control), UK; 34 50mg ViiV Healthcare A Yes UK Bottle 30 salt) coated Glaxo Wellcome S.A., Burgos (primary and secondary packaging, batch release), Spain Unit III, Plot No 22- 110 IDA, Jeedimetla, Hyderabad, Telangana, 500 055; Unit V, Sy.No.439, 440, 441 & Blister,Alu/Al Dolutegravir (as sodium Tablets, Film- 50mg Hetero Labs Ltd A HA682 458 India u; 10x8; 30x1 salt) coated TSIIC Formulation Bottle,HDPE SEZ Polepally Village, Jadcherla Mandai Mahaboobnagar District Plot No 11, 12 & 13, Indore Special Economic Zone, 10x1; Dolutegravir (as sodium Tablets, Film-Mylan Laboratories Pharma Zone, Phase Blister,PVC/ACL 50mg A HA678 India 30x1,90x1,1 salt) coated Ltd II, Sector III, AR; Bottle,HDPE 80x1 Pithampur, District Dhar, Madya Pradesh, 454 775 Cipla Ltd, Unit IV, Plot No 9, 10 & 15 Indore Special Economic Dolutegravir (as sodium Tablets, Film- Zone, Phase II, Bottle, 50mg Cipla Ltd A HA680 India 30x1;90x1 salt) coated Pithampur, Dhar HDPE District, Madhya Pradesh, 454 775, India

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 18/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Aurobindo Pharma Ltd, Unit –VII, SEZ, TSIIC, Plot No. S1, Survey No.’s 411, 425, 434, 435 & 458, Green Dolutegravir (as sodium Aurobindo Pharma ANDA 50mg Tablets B Industrial Park, India HDPE bottle 30, 90 salt) Ltd 208355 Polepally village, Jedcherla Mandal, Mahaboob Nagar District, Telangana State (Unit-2), Plot No:19, 20 & 21, Western HA718- Sector, APSEZ, Dolutegravir (as sodium Tablets, Film- 50mg Laurus Lab Ltd A-B ANDA Atchutapuram India HDPE bottle 30, 90 salt) coated 210963 Mandal,Visakhapatna m-District, Andhra Pradesh, 531011 Plot No P-2, ITBT Emcure Dolutegravir (as sodium Tablets, Film- Park, Phase II MIDC, Bottle, 50mg Pharmaceuticals A HA701 India 30x1 salt) coated Hinjwadi, Pune, HDPE Ltd Maharashtra, 411057

Village Ganguwala, Sun Dolutegravir (as sodium Tablets, Film- Paonta Sahib, District Bottle, 50mg Pharmaceutical A HA708 India 30x1, 90x1 salt) coated Sirmour, Himachal HDPE Industries Limited Pradesh, 173 025

479 Zhangheng Road, Shanghai Desano Dolutegravir (as sodium Tablets, Film- China (Shanghai) Pilot Bottle, 50mg Bio-Pharmaceutical A HA694 China 30x1 salt) coated Free Trade Zone, HDPE Co Ltd Shanghai, 201203

Plot No. S-155 to S-159 & N1, Phase III & Dolutegravir (as sodium Tablets, Film- Bottle, 30x1, 60x1, 50mg Micro Labs Ltd, A HA751 Phase IV, Verna India salt) coated HDPE 90x1 Industrial Estate, Verna, Goa, 403 722

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 19/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA

(Unit-2), Plot No:19, 20 & 21, Western Dolutegravir + NDA Sector, APSEZ, 50 mg+200 Tablets, Film- Laurus Labs Bottle, Emtricitabine+ Tenofovir B 213681 Atchutapuram India 30, 90,180 mg+25 mg coated Limited HDPE Alafenamide* Mandal,Visakhapatna m-District, Andhra Pradesh, 531011

Plot No. 11, 12 & 13 Indore Special Economic Zone Dolutegravir + NDA 50 mg+200 Tablets, Film-Mylan Laboratories Pharma Zone, Phase Bottle, Emtricitabine+ Tenofovir B 210237 India 30, 90 mg+25 mg coated Ltd II, Sector III, HDPE Alafenamide* Pithampur Dhar, Madhya Pradesh, India, 454775

Plot No. 11, 12 & 13 Indore Special Economic Zone Dolutegravir + 50 mg+300 Mylan Laboratories NDA Pharma Zone, Phase Bottle, Lamivudine+ Tenofovir Tablet B India 30, 90,180 mg+25 mg Ltd 210865 II, Sector III, HDPE Alafenamide* Pithampur Dhar, Madhya Pradesh, India, 454775

Celltrion Pharm, Inc. 82, 2 Sandan-ro, Ochang-eup, Cheongwon-gu, Cheongju-si, Chungcheongbuk-do 28117; Aizant Drug Research Dolutegravir + republic of 50mg + 300 mg Celltrion Pharm, NDA Solutions Pvt. Ltd. Survey No Lamivudine + Tenofovir Tablet B 172/173, Apparel Park Road, Korea HDPE Bottle 30, 90 + 300 mg Inc. 211912 disoproxil fumarate Dulapally Village, India Dundigal-Gandimaisamma Mandal, Medchal-Malkhajgiri District, Hyderabad, 500 100, Telangana

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 20/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA

Unit VII, SEZ, APIIC Plot No SI, Survey No 411, 425, 434, 435 and 458, Green Industrial Park, Village Polepally, Mandal Jedcherla, District Dolutegravir + Mahaboobnagar, Andhra 50mg + 300 mg Aurobindo Pharma NDA Pradesh; HDPE Lamivudine + Tenofovir Tablet B India 30, 90, 180 + 300 mg Ltd 209618 APL Health Care limited, Container disoproxil fumarate (UNIT-IV), Plot No.16, APIIC Multi Product SEZ, Menakuru Village, Naidupeta Mandal, Nellore District, telangan, Andhra Pradesh

(FDF-3) Plot No. 11, 12 & 13, Indore Special Dolutegravir + HA688 Economic Zone 50mg + 300 mg Mylan laboratories Lamivudine + Tenofovir Tablet A-B NDA Pharma Zone, Phase India HDPE Bottle 30, 90, 180 + 300 mg Ltd disoproxil fumarate 209670 II, Sector III, Pithampur District Dhar – 454775 Madhya Pradesh

Goa (Unit-VII) Verna Industrial Estate, Dolutegravir + Verna, 50mg+300mg + Salcette, Goa – 403 722C HDPE Lamivudine + Tenofovir tablet FDC Cipla Ltd A HA702 India 30, 90, 500 300mg Unit-VII PD II Container disoproxil fumarate Verna Industrial Estate, Verna Salcette, Goa - 403722

Laurus Labs Limited, (Unit- II), Plot No:19, 20 & 21, HA707- Dolutegravir + Western Sector, APSEZ, 50mg+300mg + NDA HDPE Laurus Lab Ltd A-B Atchutapuram Mandal, India 30, 90,180 Lamivudine + Tenofovir tablet FDC 210787 Container 300mg Visakhapatnam-District- disoproxil fumarate USFDA 2 531011, Andhra Pradesh

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 21/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Bock N2, Village Theda, P.O. Lodhimajra Tehsil Baddi, Dist.: Solan, Dolutegravir + NDA Himachal Pradesh, 50mg+300mg + 30, 90, 100, Lamivudine + Tenofovir tablet FDC Macleods B 210796 174101; Unit II , Plot India HDPE Bottle 300mg 180 disoproxil fumarate No. 25 – 27, Survey No. 366, Premier Industrial Estate, Kachigam, Daman – 396210

Village Ganguwala, Dolutegravir + 50mg+300mg + Sun Pharmaceutical Paonta Sahib, District Lamivudine + Tenofovir tablet FDC A HA699 India HDPE Bottle 30x1, 90x1 300mg Industries Limited Sirmour, Himanchal disoproxil fumarate Pradesh, 173 025

Unit 5, Survey No 439, 440, 441 & 458 TSIIC Formulation SEZ, Polepally Village, Jadcherla (M), Mahaboob Nagar District, Telangana, 509 Dolutegravir + HA696/ 50mg+300mg + 301; Unit III, Plot No 22-110 HDPE 30, 60, 90, Lamivudine + Tenofovir tablet FDC Hetero Labs Ltd A-B NDA IDA, Jeedimetla, Hyderabad, India 300mg Container 100,180, 750 disoproxil fumarate 210880 Telangana, 500 055Annora Pharma Private LimitedAnnaram Village, Gummadidala_Mandal Sangareddy District, Telangana State

Oral Solid Dosage Forms Dolutegravir + 50mg+300mg + Strides Pharma Division, KRS Gardens, 36/7, Bottle, 28x1, 30x1, Lamivudine + Tenofovir tablet FDC A HA729 Suragajakkanahalli, Indlawadi India 56x1, 60x1, 300mg Science Limited HDPE disoproxil fumarate Cross, Anekal Taluk, 84x1, 90x1 Bangalore, Karnataka, 562 106

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 22/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Block No. N2, Village Theda, P.O. Lodhi Dolutegravir + Macleods 30x1, 90x1, 50mg+300mg + Majra, Tehsil Baddi, Bottle, Lamivudine + Tenofovir tablet FDC Pharmaceuticals A HA713 India 100x1, 300mg District Solan, HDPE disoproxil fumarate Ltd 180x1 Himachal Pradesh, 174 101 Plot No P-1 & P-2, Dolutegravir + Emcure I.T.B.T., Park Phase II 50mg+300mg + Bottle, Lamivudine + Tenofovir Tablet Pharmaceuticals A HA722 MIDC, Hinjewadi, India 30x1, 90x1 300mg HDPE disoproxil fumarate Ltd Pune, Maharashtra, 411057 Lupin Pharmaceuticals, Inc. Dolutegravir + 111 South Calvert 30x1, 60x1, 50mg+300mg + NDA Bottle, Lamivudine + Tenofovir Tablet Street B TBD India 90x1 or 300mg 212303 HDPE disoproxil fumarate Harborplace 180x1 Tower, 24th Floor Baltimore, MD 21202 Patheon Inc. Oral Merck Sharp & Canada 35 Efavirenz (EFV) 30 mg / ml A - B Yes Mississauga, Ontario HDPE Bottle 180ml Solution Dohme Limited Netherlands Harlem Merck Sharp & Manati, Puerto Rico 36 Efavirenz (EFV) 50 mg Capsule A Yes HDPE bottle 30 Dohme Limited Harlem Netherlands

Plot No. S-155 to S- 159 & N1, Phase III & NDA Efavirenz (EFV) 50 mg Capsule Microlabs Ltd Yes IV , Verna Industrial India HDPE Bottle 30, 60, 90 205389 Estate , Verna Salcette , Goa -403 722

South Granville, BN Haarlem Merck Sharp & 37 Efavirenz (EFV) 50 mg Tablet A Yes (packager, responsible Australia HDPE bottle 30 Dohme Limited for batch release in the EU) Mylan Laboratories Sinnar,Nashik, Efavirenz (EFV) 50 mg Tablet B Yes India HDPE Bottle 30, 90 Ltd Maharashtra

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 23/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Mylan Laboratories Sinnar,Nashik, 38 Efavirenz (EFV) 100mg Tablet B Yes India HDPE Bottle 30, 90 Ltd Maharashtra Sun Dispersible 39 Efavirenz (EFV) 100mg Pharmaceutical A Yes Mohali, Punjab India HDPE Bottle 30 Tablet Industries Ltd

Plot No. S-155 to S- 159 & N1, Phase III & NDA Efavirenz (EFV) 100 mg Capsule Microlabs Ltd Yes IV , Verna Industrial India HDPE Bottle 30,60,90 205389 Estate , Verna Salcette , Goa -403 722

Plot No. L-147, L147-1, 40 Efavirenz (EFV) 200 mg Capsule Cipla Ltd. A - B Yes India HDPE Bottle 90, 1000 Verna Goa, Merck Sharp & Manati, Puerto Rico Efavirenz (EFV) 200 mg Capsule A Yes HDPE bottle 90 Dohme Limited Harlem Netherlands Sun HDPE Paonta Sahib, 90; Efavirenz (EFV) 200 mg Capsule Pharmaceutical A Yes India bottle; Himachal Pradesh 90 Industries Ltd Blister

Unit III, Survey No. 313 &314 Bachupally, Quthubullapur HDPE Aurobindo Pharma Mandal Hyderabad, 30, 90; Efavirenz (EFV) 200 mg Capsule B Yes India bottle; Ltd Andhra Pradesh 10 Blister Unit-VII (SEZ), Mahaboob Nagar (DT), Andhra Pradesh

Plot No. S-155 to S- 159 & N1, Phase III & NDA Efavirenz (EFV) 200 mg Capsule Microlabs Ltd Yes IV , Verna Industrial India HDPE Bottle 30,60,90 205389 Estate , Verna Salcette , Goa -403 722

36/7, Film coated Strides Arcolab Suragajakkanahalli 41 Efavirenz (EFV) 200 mg A-B Yes India HDPE bottle 90 Tablet Limited Indlavadi cross Anekal Taluk Bangalore

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 24/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA South Granville, BN Haarlem Merck Sharp & Efavirenz (EFV) 200 mg Tablet A Yes (packager, responsible Australia HDPE bottle 90 Dohme Limited for batch release in the EU) Mylan Laboratories Sinnar,Nashik, Efavirenz (EFV) 200 mg Tablet B Yes India HDPE Bottle 30, 90 Ltd Maharashtra Bristol-Myers Squibb Pharma, Manati, Puerto Rico; Merck Sharp & Dohme Australia Pty. Ltd, Puerto Rico South Granville, Merck Sharp & Australia 42 Efavirenz (EFV) 600 mg Tablet A Yes Australia; HDPE bottle 30 Dohme Limited Netherlands Merck Sharp & China Dohme, BV Haarlem, The Netherlands; Zhejiang Huahai Pharmaceutical Co., Ltd, Zhejiang, China Sun Paonta Sahib, HDPE bottle 30; Efavirenz (EFV) 600 mg Tablet Pharmaceutical A Yes India Himachal Pradesh Blister; 30 Industries Ltd

Unit III Survey No. 313, Bachupally, Quthubullapur HDPE Tablet Film Aurobindo Pharma Mandal, Hyderabad, 30, Efavirenz (EFV) 600 mg B Yes India Bottle; coated Ltd Andhra Pradesh 10 Blister Unit-VII (SEZ), Mahaboob Nagar (DT), Andhra Pradesh

HDPE 28, 30; Mylan Laboratories Sinnar,Nashik, Efavirenz (EFV) 600 mg Tablet A - B Yes India bottle; Ltd Maharashtra Blister 10

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 25/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA 1479 Zhangheng Road, Shanghai Desano Zhangjiang Hi-Tech Efavirenz (EFV) 600 mg Tablet Bio-pharmaceutical A HA658 China HDPE bottle 30x1 Park, Shanghai Co. 201203 L-139 to L-146, Verna Goa India HDPE bottle 30, 500 Efavirenz (EFV) 600 mg Tablet Cipla Ltd. A - B Yes Quality Chemical Uganda Blister 10 Industries Ltd, Kampala

Universal Corporation Ltd, PO Box 1748, Club Road, Plot No 13777, Kikuyu, 902; Strides Shasun Ltd, Oral Solid Dosage Film coated Strides Arcolab Efavirenz (EFV) 600 mg A-B HA390 Forms Division, KRS Kenya; India HDPE bottle 30 Tablet Limited Gardens, 36/7, Suragajakkanahalli, Indlawadi Cross, Anekal Taluk, Bangalore, Karnataka, 562 106

Unit-III, Jeedimetla, Hyderabad, Andhra Tablet Film Pradesh, India; HDPE Efavirenz (EFV) 600 mg Hetero labs limited A-B Yes India 28, 30, 250 coated Unit-V, Mahaboob Container Nagar, Andhra Pradesh, India Macleods HDPE Efavirenz (EFV) 600 mg Tablet Pharmaceuticals A-B Yes Himachal Pradesh India 30 container Limited Emcure HDPE 30, 60; Efavirenz (EFV) 600 mg Tablet Pharmaceuticals B Yes Hinjwadi, Pune India bottle; 3*10 Limited Blister HDPE 30x1 Efavirenz (EFV) 600 mg Tablet Microlabs Ltd A-B HA633 Verna, Goa India bottle; 10x3 Blister

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 26/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Aspen Port Elizabeth , Pharmacare (Pty) Ltd, Korsten Port Layflat laminat Bag(PET/Alu/ 30 Efavirenz (EFV) 600 mg Tablet Ltd.(trading as A HA649 Elizabeth, South Africa LLDPE) 30 Aspen Pharmacare) South Africa HDPE Bottle

Lek Pharmaceuticals d.d., Ljubljana or Salutas Pharma GmbH, 10, 28, 30, 39179 Barleben, White or 50, Slovenia opaque LEK S.A., 60, 84, 90, Film coated 672 Warszawa Germany PVC/Aclar/ Efavirenz (EFV) 600 mg Sandoz Ltd, UK B Yes 100 or 120 Tablet or Poland Al blisters 30, 90 Salutas Pharma GmbH, Romania HDPE Dieselstr. 5, 70839 Gerlingen, (3x30) or bottles Germany 120 (4x30) or S.C. Sandoz, Targu-Mures

The Government Pharmaceutical Government Organization (GPO), Pharmaceutical Rangsit Organization Pharmaceutical Film coated (GPO), 75/1 Rama Efavirenz (EFV) 600 mg A HA681 Production Plant 1, Thailand HDPE bottle 30 Tablet VI Road, 138 Moo 4, Rangsit- Ratchathewi, Nakhonnayok Road, Bangkok, 10400, Bueng Sanan, Thailand Thanyaburi, Pathumthani, 12110

36/7, Efavirenz + [Lamivudine 600 mg + [150 Strides Arcolab Suragajakkanahalli Tablet B Yes India HDPE bottle 30 + (60) + Zidovudine] mg + 300 mg] Limited Indlavadi cross Anekal Taluk Bangalore

10-day supply (5 two- Efavirenz + [Lamivudine 600 mg + [150 Co packed Mylan Laboratories Sinnar, Nashik District Blister day blister cards B Yes India consisting of + Zidovudine] mg + 300 mg] Tablet Ltd 422 113, Maharashtra cards. PVC/PvDC film and coated aluminum foil)

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 27/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Patheon Inc. Efavirenz + Mississauga, Ontario 600 mg + 200 Merck Sharp & 44 Emtricitabine + Tablet B Yes MSD BV Haarlem ( Canada HDPE bottle 30 mg + 300 mg Dohme Limited Tenofovir packaging and batch release site) Sinnar,Nashik, Maharashtra, Efavirenz + Waluj, Aurangabad, Emtricitabine + 600 mg + 200 Mylan Laboratories Tablet A-B Yes Maharashtra; India HDPE bottle 28, 30, 100 Tenofovir Disoproxil mg + 300 mg Ltd Mylan Pithambur, Fumarate Dhar Dist., Madhya Pradesh Efavirenz + 600 mg + 200 Plot No. L-147, L147-1, Emtricitabine + Tablet Cipla Ltd. A Yes India HDPE Bottle 30 mg + 300 mg Verna Goa, Tenofovir

Efavirenz + Unit-VII (SEZ), 600 mg + 200 Aurobindo Pharma Emtricitabine + Tablet B Yes Mahaboob Nagar India HDPE Bottle 30, 100 mg + 300 mg Ltd Tenofovir (DT), Andhra Pradesh

Hetero Labs Limited, Efavirenz + Unit-V SEZ Unit I 600 mg + 200 HDPE 28's, 30's Emtricitabine + Tablet Hetero labs limited A-B Yes Survey No. 439, 440, India mg + 300 mg Bottle and 500's, Tenofovir 441 & 458 Mahaboob Nagar. Efavirenz + Macleods 600 mg + 200 Emtricitabine + Tablet Pharmaceuticals A-B Yes Kachigam, Damam India HDPE Bottle 30 mg + 300 mg Tenofovir Limited Efavirenz + 600 mg + 200 Strides Arcolab Anekal Taluk, Emtricitabine + Tablet A Yes India HDPE Bottle 30 mg + 300 mg Limited Bangalore, India Tenofovir Efavirenz + Bristol-Myers 600 mg+200 Carrigtohill, County Emtricitabine + Tablet Squibb and Gilead B Yes Ireland HDPE Bottle 30 mg+300 mg Cork Tenofovir Disoproxil Sciences Ltd Efavirenz + 600 mg+200 Gilead Sciences, Patheon Inc. Emtricitabine + Tablet B Yes Canada HDPE Bottle 30 mg+300 mg Inc. Mississauga, Ontario Tenofovir( Disoproxil

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 28/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA

Sinnar,Nashik, Maharashtra; Efavirenz+ Lamivudine + H-12 & H-13, M.I.D.C, 600 mg + 300 Mylan Laboratories 45 Tenofovir (Disoproxil Tablet A- B Yes Waluj, Aurangabad India HDPE Bottle 30, 100 mg + 300 mg Ltd Fumarate) Maharastra; Mylan Pithambur, Dhar Dist., Madhya Pradesh

Aurobindo Pharma Efavirenz+ Lamivudine + 600 mg + 300 Aurobindo Pharma Limited Unit-VII Tenofovir (Disoproxil Tablet B Yes India HDPE Bottle 30, 90& 500 mg + 300 mg Ltd (SEZ) Mahaboob Fumarate) Nagar (Dt) AP; Plot No 1-7 Ring Road, Luzira Industrial Park, Kampala, Uganda Unit 7, Plot No L-139 to L- 147-1, S-103 to S-105, S-107 to S-112 & M-61 to M-63, Efavirenz+ Lamivudine + 600 mg + 300 Verna Industrial Estate, Tenofovir (Disoproxil Tablet Cipla Ltd. A-B HA593 India HDPE Bottle 30 mg + 300 mg Salcette, Goa, 403 722, Fumarate) Unit 2, Plot A-42 MIDC Industrial Area, Patalganga, Raigad District, Maharashtra, 410 220

Macleods Efavirenz+ Lamivudine + Macleods Pharmaceuticals 600 mg + 300 Tenofovir (Disoproxil Tablet Pharmaceuticals A-B Yes Limited India HDPE Bottle 30 mg + 300 mg Fumarate) Limited Baddi, District Solan, Himachal Pradesh

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 29/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA

Unit III, Survey No 51, Plot No 22-110 IDA, Jeedimetla, Hyderabad, Telangana (Unit-V) S.No. Efavirenz+ Lamivudine + HA549 439,440, 441, & 458, 600 mg + 300 HDPE Tenofovir (Disoproxil Tablet Hetero labs limited A-B NDA TSIIC Formulation India 30, 90, 100 mg + 300 mg Container Fumarate) 204119 SEZ, Polepally Village, Jadcherla (Mandal), Mahaboobnagar- (District). Pin-509301 Telangana

(Unit-2), Plot No:19, 20 & 21, Western Efavirenz+ Lamivudine + HA727- Sector, APSEZ, 600 mg + 300 Laurus Labs Tenofovir (Disoproxil tablet FDC A-B ANDA Atchutapuram India HDPE Bottle 30x1, 90x1 mg + 300 mg Limited Fumarate) 212786 Mandal,Visakhapatna m-District, Andhra Pradesh, 531011

(FDF-3) Plot No. 11, 12 & 13, Indore Special Efavirenz+ Lamivudine + Economic Zone, 400 mg + 300 Mylan Laboratories HDPE Bottle Tenofovir (Disoproxil Tablet A-B HA721 Pharma Zone, Phase - India 30 mg + 300 mg Ltd (white, blue) Fumarate) II, Sector -III, Pithampur, District Dhar - 454775, Madhya Pradesh

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 30/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA (Unit-2), Plot No:19, 20 & 21, Western Efavirenz+ Lamivudine + HA732- Sector, APSEZ, 400 mg + 300 Laurus Labs HDPE Tenofovir (Disoproxil tablet FDC A-B ANDA Atchutapuram India 30, 90, 180 mg + 300 mg Limited Container Fumarate) 213038 Mandal,Visakhapatna m-District, Andhra Pradesh, 531011

Block N-2, Village Theda; Efavirenz+ Lamivudine + HA714- Post Office 400 mg + 300 HDPE Tenofovir (Disoproxil tablet FDC Macleods A-B NDA Lodhimajra Tehshil India 30, 90, 180 mg + 300 mg Container Fumarate) 210649 Baddi, Distt.Solan, Himachal Pradesh-174101

Gilead Sciences, 46 Emtricitabine 10 mg/ml oral solution B Yes Country Cork Ireland Bottle 170ml Inc. Plot No. L-147, L147-1, 47 Emtricitabine 200 mg Capsule Cipla Ltd. A - B Yes India HDPE Bottle 30, 1000 Verna Goa, HDPE Mylan Laboratories Sinnar,Nashik, 30, 100; Emtricitabine 200 mg Capsule A - B Yes India Bottle; Ltd Maharashtra 2*10, 3*10 Blister Gilead Sciences, HDPE Emtricitabine 200 mg Capsule B Yes Foster City USA 30 Inc. Bottle, Plot No.11, 12 & 13, Indore Special Economic Zone, NDA Pharma Zone, Phase - Emtricitabine 200 mg Capsule Micro Labs Ltd, B India HDPE Bottle 30,60,90 204396 II, Sector - III, Pithampur – 454775 Dist. Dhar, Madhya Pradesh. 30, Emtricitabine +Tenofovir Tablet Film Gilead Sciences, Granta Park Abington, Bottle 49 200 mg + 245 mg B Yes UK 90(3x30) Disoproxil Fumarate coated Inc. Cambridge (HDPE) tablets

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 31/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Altana Pharma, Oranienburg GmbH, Germany Emtricitabine + 200 mg + 300 Gilead Sciences, Patheon Inc. Tablet A Yes Canada HDPE bottle 30 Tenofovir mg Inc. Mississauga, Ontario South Africa Aspen Pharmacare, Port Elizabeth,

Unit - III Survey No. 313 & 314, Bachupally, Quthubullapur Emtricitabine + 200 mg + 300 Aurobindo Pharma Mandal Hyderabad, Tenofovir disoproxil Tablet B Yes India HDPE bottle 30 mg Ltd Andhra Pradesh fumarate Unit-VII (SEZ), Mahaboob Nagar (DT), Andhra Pradesh

Emtricitabine + HDPE 200 mg + 300 Mylan Laboratories Sinnar,Nashik, 28, 30,100; Tenofovir Disoproxil Tablet A - B Yes India bottle; mg Ltd Maharashtra 10 Fumarate blister Emtricitabine + 200 mg + 300 Plot No. L-147, L147-1, Tenofovir Disoproxil Tablet Cipla Ltd. A-B Yes India HDPE Bottle 30 mg Verna Goa, Fumarate Unit III 22 - 110, Emtricitabine + Industrial 200 mg + 300 28, 30, 56 & Tenofovir Disoproxil Tablet Hetero labs limited A-B Yes development Area, India HDPE bottle mg 60 Fumarate Jeedimetla, Hyderabad-500055

36/7, Emtricitabine + 200 mg + 300 Strides Arcolab Suragajakkanahalli Tenofovir Disoproxil Tablet A-B Yes India HDPE bottle 30 mg Limited Indlavadi cross Anekal Fumarate Taluk Bangalore

HDPE Emtricitabine + Macleods 200 mg + 300 bottleAlu/Al 30; Tenofovir Disoproxil Tablet Pharmaceuticals A Yes Kachigam, Daman, India mg u 10 x 10 Fumarate Limited blister

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 32/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Aspen Port Elizabeth , Emtricitabine + (Pty) Ltd, Korsten Port 200 mg + 300 Tenofovir Disoproxil Tablet Pharmacare Ltd A HA601 Elizabeth, South Africa HDPE bottle 30 mg Fumarate South Africa

Shasun Emtricitabine + Sun Pharmaceuticals 200 mg + 300 Tenofovir Disoproxil Tablet Pharmaceutical A Yes Limited, India HDPE bottle 30 mg Fumarate Industries Ltd Periyakalapet, Puducherry, India Micro Labs Ltd, Phase III and Phase IV, Plot Emtricitabine + Blister 200 mg + 300 No S-155 to S-159 10x1 Tenofovir Disoproxil Tablet Microlabs Ltd A HA631 India Alu/Alu mg Verna Industrial 30x1, 100x1 Fumarate Bottle HDPE Estate, Verna, Goa, 403 722, India (Unit-2), Plot No:19, 20 & 21, Western Emtricitabine + Sector, APSEZ, 200 mg + 300 Tablet Film Tenofovir Disoproxil Laurus Lab Ltd A HA717 Atchutapuram India Bottle, 30x1, 90x1 mg coated Fumarate Mandal,Visakhapatna HDPE m-District, Andhra Pradesh, 531011

Plot No. 6A1, 6A2, Emtricitabine + Sector-17, Special 200 mg + 300 Tablet Film Tenofovir Disoproxil Lupin Ltd A HA715 Economic Zone, India Bottle, 30x1 mg coated Fumarate MIHAN, Nagpur, HDPE Maharashtra, 441 108

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 33/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA

Plot No P-2, ITBT Emtricitabine + Emcure 200 mg + 300 Tablet Film Park, Phase II MIDC, Tenofovir Disoproxil Pharmaceuticals A HA726 India Bottle, 30x1 mg coated Hinjwadi, Pune, Fumarate Ltd HDPE Maharashtra, 411057

Cartons containing 5 blister packs (consisting of [Emtricitabine + 200 mg /300 mg aluminum-aluminum Co packed Mylan Laboratories Sinnar, Nashik District Blister blisters), each 50 Tenofovir Disoproxil co-packaged with B Yes India containing two 1-day Tablet Ltd 422 113, Maharashtra cards. cards, for a 10 day Fumarate]+Nevirapine 200 mg supply. Three cartons are further packaged together for a 30 day supply [Emtricitabine + 200 mg /300 mg Macleods Co packed Alu/Alu (1 + 2) Tenofovir Disoproxil co-packaged with Pharmaceuticals A Yes Kachigam, Daman, India Tablet blister combipack Fumarate]+Nevirapine 200 mg Limited 60+60 vials Hoffmann-La 51 Enfuvirtide 90mg/ml Injection B Yes Basle Switzerland Vials of water for Roche Inc. inj+syringe Janssen-Cilag Janssen-Cilag SpA, 52 Etravirine 25mg Tablet International NV, A-B Yes Italy HDPE Bottle 120 Latina, Italy Belgium Borgo San Michele, Latina Janssen Infectious Janssen-Cilag SpA, Diseases - Latina, Italy 53 Etravirine 100mg Tablet Diagnostics BVBA/ A-B Yes Italy HDPE Bottle 120 (Manufacturing, Pharmacare South packaging, release Africa testing and final QC release) Janssen-Cilag Janssen-Cilag SpA, 54 Etravirine 200mg Tablet International NV, A-B Yes Italy HDPE Bottle 60 Latina, Italy Belgium

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 34/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Glaxo SmithKline Glaxo Wellcome 55 Fosamprenavir (FPV) 700 mg Tablet B Yes UK HDPE bottle 60 Ltd. Operations Capsule Merck Sharp & Hertford Road, 180,270, 56 Indinavir (IDV) 200 mg B Yes UK HDPE Bottle Hard Dohme Limited Hertfordshire 360 Unit-III, Jeedimetla, Hetero Labs Al/Al strip; 10; 57 Indinavir (IDV) 400 mg Capsule A Yes Hyderabad, Andhra India Limited HDPE bottle 180 Pradesh, India Merck Sharp & Indinavir (IDV) 400 mg Capsule A Yes Elkton, Virgina USA HDPE bottle 180 Dohme Limited Capsule Merck Sharp & Hertford Road, Bottle Indinavir (IDV) 400 mg B Yes UK 18, 90, 180 Hard Dohme Limited Hertfordshire (HDPE) Oral 58 Lamivudine (3TC) 10 mg / ml ViiV HealthCare A Yes Mississauga, Ontario Canada HDPE bottle 240ml Solution Unit-III 22-110, Industrial Oral Lamivudine (3TC) 10 mg / ml Hetero labs limited B Yes Development Area India HDPE Bottle 240ml Solution Jeedimetla, Hyderabad Oral Aurobindo Pharma Lamivudine (3TC) 10 mg / ml B Yes Hyderabad, Telangana India HDPE Bottle 240ml Solution Ltd Macleods Oral Solan, Himachal Lamivudine (3TC) 10 mg / ml Pharmaceuticals A Yes India HDPE Bottle 240ml Solution Pradesh, India Limited 59 Lamivudine (3TC) 30mg Tablet Cipla Ltd. A Yes Goa India HDPE Bottle 60

PVC/PVdC/ 10 Lamivudine (3TC) 30mg Tablet Microlabs Ltd A Yes Verna, Goa India Alu blister ; 60,100,500, HDPE bottle 1000 Sun Paonta Sahib, 60 Lamivudine (3TC) 30mg Disp Tablet Pharmaceutical A Yes India HDPE Bottle 60 Himachal Pradesh Industries Ltd Tablet Film Glaxo SmithKline Blister; 61 Lamivudine (3TC) 100 mg B Yes Ware, Hartfordshire UK 28, 84 coated Ltd. Bottle Macleods HDPE Tablet Film Kachigam, Daman 60; 62 Lamivudine (3TC) 150 mg Pharmaceuticals A - B Yes India Bottle; Coated Baddi, H.P. 6*10 Limited Blister

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 35/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA

36/7, HDPE Film coated Strides Arcolab Suragajakkanahalli 30, 60; Lamivudine (3TC) 150 mg A-B Yes India bottle; Tablet Limited Indlavadi cross Anekal 10 Blister Taluk Bangalore

Metallised Aspen Pharmacare Port Elizabeth, Lamivudine (3TC) 150 mg Tablet A Yes South Africa lay flat pack, 60 Ltd. Korsten PP bottle Goa; Lamivudine (3TC) 150 mg Tablet Cipla Ltd. A Yes Meditab Specialities India HDPE Bottle 30, 60 Ltd, Goa

Glaxo Operations UK, Ltd, Ware, Hertfordshire, UK; Tablet Film GSK, Poznan UK Lamivudine (3TC) 150 mg ViiV HealthCare A - B Yes HDPE bottle 60 coated (packaging and South Africa release), Poland Pharmacare (ASPEN), Port Elizabeth,

Unit-III, Jeedimetla, Hyderabad, Andhra Pradesh, India; India HDPE Bottle 60, 600 Lamivudine (3TC) 150 mg Tablet Hetero labs limited A-B Yes STADA-VN Joint Vietnam Blister, 10; Venture Co, Ltd, Duong Province, Vietnam

Alu/PVC/Pv 6x10 Lamivudine (3TC) 150 mg Tablet Microlabs Ltd A-B HA644 Verna, Goa India dC blister 60 HDPE Bottle Sun HDPE Paonta Sahib, 60, Lamivudine (3TC) 150 mg Tablet Pharmaceutical A - B Yes India Bottle, Himachal Pradesh 10 Industries Ltd Blister Alkem Laboratories Lamivudine (3TC) 150 mg Tablet B Yes Amaliya, Daman India HDPE Bottle 60 Ltd

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 36/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Centaur Biotech Park Lamivudine (3TC) 150 mg Tablet Pharmaceutical B Yes Hinjewadi Phase II India HDPE bottle 60 Private Limited Pune, Maharashtra Mylan Laboratories Limited, Blister F- 4 & F-12, MIDC, NDA# PVC/PVDC/ Lamivudine (3TC) 150 mg Tablet MYLAN B Malegaon, India 10x1 ; 60x1 078545 Aluminium) Sinnar, Nashik - 422 HDPE bottle 113 Maharashtra Mylan Laboratories Limited, Blister ANDA F- 4 & F-12, MIDC, PVC/PVDC/ 63 Lamivudine (3TC) 300 mg Tablet MYLAN A-B 078545 Malegaon, India Aluminium) 10x1 ; 60x1 USFDA 2 Sinnar, Nashik - 422 ; 113 HDPE bottle Maharashtra

Lamivudine (3TC) 300 mg Tablet Cipla Ltd. A Yes Goa India HDPE Bottle 30,60

36/7, Film coated Strides Arcolab Suragajakkanahalli HDPE Lamivudine (3TC) 300 mg B Yes India 30; 60 Tablet Limited Indlavadi cross Anekal Bottle, Taluk Bangalore

Macleods HDPE 30; Lamivudine (3TC) 300 mg Tablet Pharmaceuticals A - B Yes Kachigam, Daman India Bottle; 3* 10; 6*10 Limited Blister

High density Glaxo SmithKline polyethylene Lamivudine (3TC) 300 mg Tablet B Yes Greenford, Middlesex UK 30 Ltd. (HDPE) bottle

Unit III 22-110, I.D.A., Lamivudine (3TC) 300 mg Tablet Hetero labs limited B Yes Jeedimetla Jeedimeta, India HDPE bottle 30, 600 Hyderabad

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 37/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA

HDPE bottle 30, 60, 90 Lamivudine (3TC) 300 mg Tablet Microlabs Ltd B Yes Verna, Goa India Blister 10

Track-II, 126, Beximco Film-coated Kathaldia, Auchpara, HDPE Lamivudine (3TC) 300 mg Pharmaceuticals A HA668 Bangladesh 30x1 Tablet Tongi-1711, Gazipur, Bottle Limited Bangladesh

Sinnar, Nashik District, Maharashtra, Lamivudine + Nevirapine 30mg+ 50mg Dispersible Mylan Laboratories 67 A -B Yes India; India HDPE Bottle 60 + Zidovudine +60mg Tablet Ltd Waluj, Aurangabad, Maharashtra, India

Strides Pharma Science Limited, Tablet for Strides house, Opp. Lamivudine + Nevirapine 30mg+ 50mg Strides Pharma Oral A-B HA557 IIMB, Bilekahali, India HDPE Bottle 60 + Zidovudine +60mg Science Limited Suspension Bannerghatta Road, Bangalore, Karnataka, 560 076, India

Plot No. L-147, L147-1 Tablet for (Unit VII), Verna Lamivudine + Nevirapine 30mg+ 50mg Oral Cipla Ltd. B Yes Industrial Estate, India HDPE Bottle 60, 1000 + Zidovudine +60mg Suspension Verna Salcette Goa, 403 722 Unit III Plot No. 22-110, Lamivudine + Tenofovir NDA 75 mg + 75 mg Tablet Hetero labs limited B I.D.A., Jeedimetla, India HDPE Bottle 30 disoproxil fumarate 207315 Hyderabad – 500 055, Telangana

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 38/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Unit-III, 22-110, Industrial Development Area, Jeedimetla, Lamivudine + Tenofovir 300 mg + 300 30, 60, 100, 70 Tablet Hetero labs limited A-B Yes Hyderabad; India HDPE Bottle disoproxil fumarate mg 500 and Unit V Mahaboob Nagar Dist, Andhra Pradesh. Celltrion Pharm, Inc. 82, 2Sandan-ro, HA712- Lamivudine + Tenofovir 300 mg + 300 Celltrion Pharm, Ochang-eup, Republic of Tablet A-B NDA HDPE Bottle 30, 60, 100 disoproxil fumarate mg Inc. Cheongwon-gu, Korea 211284 Cheongju-si, Chungcheongbuk-do Mylan Laboratories Ltd, F4 & F12 Malegaon MIDC, Sinnar, Nashik District, Maharashtra, 422 113; Lamivudine + Tenofovir 300 mg + 300 Mylan Laboratories Mylan Laboratories Tablet A-B Yes India, Kenya HDPE bottle 30, 100 disoproxil fumarate mg Ltd Ltd, Plot No H-12 & H13 MIDC Waluj Industrial Area, Aurangabad, Maharashtra, 431 136; Questa Care Limited, Plot No. 209/7184, Unit-VII (SEZ), Lamivudine + Tenofovir 300 mg + 300 Aurobindo Pharma Tablet B Yes Mahaboob Nagar India HDPE bottle 30 disoproxil fumarate mg Ltd (DT), Andhra Pradesh

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 39/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA

D-7 MIDC Kurkumbh; Quality 30, 500 Lamivudine + Tenofovir 300 mg + 300 HDPE Bottle Tablet Cipla Ltd. A- B HA666 Chemical Industries India disoproxil fumarate mg Blister Ltd, Kampala, 10 Uganda

Sun Lamivudine + Tenofovir 300 mg + 300 Shasun Tablet Pharmaceutical A-B Yes India HDPE Bottle 30 disoproxil fumarate mg Pharmaceuticals Ltd Industries Ltd Macleods Kachigam- Daman Lamivudine + Tenofovir 300 mg + 300 HDPE Bottle 30 Tablet Pharmaceuticals A-B Yes Baddi- Himachal India disoproxil fumarate mg Blister 10 Limited Pradesh Plot No: S-155 to S- 159, Phase III, Lamivudine + Tenofovir 300 mg + 300 Tablet Microlabs Ltd A HA620 Verna Industrial India HDPE Bottle 30, 100 disoproxil fumarate mg Estate, Verna, Goa- 403722

Plot No. 6A1, 6A2, Sector-17, Special Lamivudine + Tenofovir 300 mg + 300 Tablet Lupin Ltd A HA703 Economic Zone, India HDPE Bottle 30 disoproxil fumarate mg MIHAN, Nagpur, Maharashtra, 441 108

Alu/Alu (1+1+1) per Capsules+ Sinnar,Nashik, [Lamivudine+Tenofovir] [300mg+300mg] Mylan Laboratories Blister per coblister; 3 71 Tablets+ A Yes Maharashtra India +Atazanavir+ Ritonavir +300mg+100mg Ltd co packed blisters in a Tablets blister carton Sinnar-Nashik, Lamivudine + Dispersible Mylan Laboratories 73 30 mg + 60 mg A -B Yes Maharashtra India HDPE 60 Zidovudine Tablet Ltd Waluj, Aurangabad Sun Lamivudine + Dispersible Paonta Sahib, 30 mg + 60 mg Pharmaceutical A Yes India HDPE Bottle 60 Zidovudine Tablet Himachal Pradesh Industries Ltd

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 40/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA L-147 to L-147.1 (Unit VII), Verna Industrial HDPE Lamivudine + Dispersible NDA 60; 1000 30 mg + 60 mg Cipla Ltd. B Estate, India bottle; Zidovudine Tablet 202814 10 Verna Salcette, Goa Blister 403 722 India

Plot No 11, 12 & 13, Indore Special Economic Zone, Pharma Zone, Phase II, Sector Lamivudine + Dispersible Mylan Laboratories HA572; III, Pithampur, District Dhar, 30 mg + 60 mg A -B Madya Pradesh, 454 775: India HDPE 60 Zidovudine Tablet Ltd NDA Plot No H-12 & H13 MIDC Waluj Industrial Area, Aurangabad, Maharashtra, 431 136

Sinnar-Nashik, Lamivudine + Mylan Laboratories 74 30 mg + 60 mg Tablet A -B Yes Maharashtra India HDPE 60 Zidovudine Ltd Waluj, Aurangabad 6 x 10; PVC/PVdC/ Lamivudine + 30 mg + 60 mg Tablet Microlabs Ltd A Yes Verna, Goa India Alu blister Zidovudine 60, 100, HDPE 1000

Shanghai Desano Bio- Pharmac+H309eutical Shanghai Desano Co Ltd, 1479 Lamivudine + 150 mg + 300 mg Tablet Bio-Pharmaceutical A HA655 Zhangheng Road, China HDPE bottle 60' Zidovudine Co Ltd China (Shanghai) Pilot Free Trade Zone, Shanghai, 201203

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 41/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Plot No. L-147, L147-1, Verna Goa, Indore, SEZ, Pithampur, Dist Dhar (M.P.), India; Quality Chemical HDPE bottle Lamivudine + Industries Ltd, India 60, 1000 ; 150 mg + 300 mg Tablet Cipla Ltd. A - B Yes ; Zidovudine Kampala, Uganda; Uganda 10, 14 Blister Cipla Ltd Baddi, Himachal Pradesh, India Meditab Specialities Pvt Ltd, Kundaim, Goa Unit-III, 22-110, Lamivudine + Hetero Labs Jeedimetla, HDPE bottle 60, 500 150 mg + 300 mg Tablet A-B Yes India Zidovudine Limited Hyderabad Blister; 10; Unit-V, Hyderabad Sinnar,Nashik, Maharashtra; Mylan Laboratories Limited, Plot No.11, 12 & 13, Indore Special HDPE bottle Lamivudine + Mylan Laboratories 60; 150 mg + 300 mg Tablet A - B Yes Economic Zone, India ; Zidovudine Ltd 10 Pharma Zone, Phase - Blister II, Sector - III, Pithampur – 454775 Dist. Dhar, Madhya Pradesh. Glaxo Operations UK, Ltd, Ware, Lamivudine + Hertfordshire, UK; Bottle 60, 150 mg + 300 mg Tablet ViiV HealthCare A Yes UK Zidovudine GSK, Poznan Blister, 60 (packaging and release), Poland

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 42/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA HDPE bottle; Sun Lamivudine + Paonta Sahib, Alu/PA/PVC 60; 150 mg + 300 mg Tablet Pharmaceutical A Yes India Zidovudine Himachal Pradesh Blister; 10 Industries Ltd PVdC/PVC blister Anhui Biochem Bio- pharmaceutical Co., Anhui Biochem Bio- Ltd., No. 30 Hongfeng China Lamivudine + Film coated 150 mg + 300 mg pharmaceutical A HA656 Road, Hi-Tech (People's HDPE bottle 60 Zidovudine Tablet Co., Ltd., Development Zone, Republic of) Hefei City, Anhui Province

36/7, Lamivudine + Film coated Strides Arcolab Suragajakkanahalli 150 mg + 300 mg A-B Yes India HDPE bottle 60 Zidovudine Tablet Limited Indlavadi cross Anekal Taluk Bangalore

Lamivudine + Universal 150 mg + 300 mg Tablet A HA490 Kikuyu Kenya HDPE 60 Zidovudine Corporation HDPE Lamivudine + bottle; 30, 60, 90; 150 mg + 300 mg Tablet Microlabs Ltd A Yes Verna, Goa India Zidovudine PVDC/PVC/ 10*10; Alu blister; Lamivudine + Port Elizabeth, 150 mg + 300 mg Tablet Pharmacare Ltd. B Yes South Africa Blister 60 Zidovudine Korsten Macleods HDPE Lamivudine + Kachigam, Daman 60; 150 mg + 300 mg Tablet Pharmaceuticals A -B Yes India Bottle; Zidovudine Baddi, H.P. 6*10, 12*10 Limited Blister Emcure Lamivudine + HDPE bottle 60 150 mg + 300 mg Tablet Pharmaceuticals B Yes Hinjwadi, Pune India Zidovudine Blister 10 Limited

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 43/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Dhar, Pithampur, Lamivudine + 150 mg + 300 mg Tablet Lupin A Yes Madhya Pradesh; India HDPE bottle 60 Zidovudine Verna, Salcette Goa,

AbbVie Inc., 1 N Waukegan Road, IL 60064, North Chicago, Aesica Queenborough HA098N Lopinavir (LPV) + (80 mg + 20 mg) Oral Limited, North Road, USA, UK, 78 AbbVie Ltd A -B DA PET bottle 160ml Ritonavir (RTV) / ml Solution Queenborough, Kent, Netherlands 021251 ME11 5EL, UPS SCS B.V., Marco Poloweg 22-24, 5928 LE Venlo, Netherlands

Plot L147 to L-147-1, Pellets in NDA Verna Industrial 79 Lopinavir+Ritonavir 40mg/10mg Cipla Ltd. B India HDPE Bottle 120 Capsule 205425 Estate, MylanVerna, Laboratories Goa Limited (FDF-1) Plot # F/4 & F/12, Malegaon MIDC Sinnar, Nashik District- 422113 Maharashtra; Mylan Laboratories HA697- Oral Mylan Laboratories Limited, Plot No.11, 12 aluminum Lopinavir+Ritonavir 40mg/10mg A-B NDA India 120 Granules Limited & 13, Indore Special foil sachets 210540 Economic Zone, Pharma Zone, Phase - II, Sector - III, Pithampur – 454775 Dist. Dhar, Madhya Pradesh. EMA Art Lopinavir (LPV) + 100 mg + 25 mg Tablet AbbVie Ltd B 58 H-W- Ludwigshafen Germany HDPE bottle 60 Ritonavir (RTV) 764-2

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 44/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA

Bottle Lopinavir (LPV) + NDA2190 100 mg + 25 mg Tablet AbbVie Ltd B North Chicago USA (HDPE) 60 Ritonavir (RTV) 6 Bottle (PVC) Mylan Laboratories Limited, F-4, F-12, Malegaon M.I.D.C, Sinnar, Nashik – 422113, Maharashtra state, Lopinavir (LPV) + Mylan Laboratories HA429 100 mg + 25 mg Tablet A-B ANDA#7907 India ;Mylan India HDPE Bottle 60, 120 Ritonavir (RTV) Ltd 4 Laboratories Limited, Plot No.11, 12 & 13, Indore Special Economic Zone, Pharma Zone, Phase - II, Sector - III, Pithampur – 454775 Unit III Survey No. 313 and 314 HDPE Lopinavir (LPV) + Aurobindo Pharma Bachupally 60; 100 mg + 25 mg Tablet B Yes India Bottle; Ritonavir (RTV) Ltd Quthubullapur 6*10 Blister Mandal, Hyderabad Andhra Pradesh Macleods Lopinavir (LPV) + Solan, Himachal 100 mg + 25 mg Tablet Pharmaceuticals A Yes India HDPE bottle 60 Ritonavir (RTV) Pradesh Limited

Unit III, Plot No 22- ANDA Lopinavir (LPV) + 110 IDA, Jeedimetla, 100 mg + 25 mg Tablet Hetero labs limited A-B 091677 India HDPE bottle 60; 120 Ritonavir (RTV) Hyderabad, HA650 Telangana, 500 055

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 45/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Sinnar,Nashik, Maharashtra; Mylan Laboratories Limited, Plot No.11, 12 & 13, Indore Special HDPE Lopinavir (LPV) + Mylan Laboratories 120; 82 200 mg + 50 mg Tablet A - B Yes Economic Zone, India Bottle; Ritonavir (RTV) Ltd 6. 12 Pharma Zone, Phase - Blister II, Sector - III, Pithampur – 454775 Dist. Dhar, Madhya Pradesh.

AbbVie LTD., Deutschland GmbH and Com KG, Knollstrasse 67061, Ludwigshafen, AbbVie LTD., KM 58 HA381, Carretera, 2 Cruce Lopinavir (LPV) + Germany, Bottle 200 mg + 50 mg Tablet AbbVie Ltd A-B NDA2190 Davilla, Barceloneta 120x1 Ritonavir (RTV) Ireland HDPE, 6 00617, Puerto Rico Fournier Laboratories Ireland Limited, Carrigtwohill business park, Anngrove, Carrigtwohill, Co. Cork

Unit III Survey No. 313 and 314 HDPE Lopinavir (LPV) + Aurobindo Pharma Bachupally 120; 200 mg + 50 mg Tablet B Yes India Bottle; Ritonavir (RTV) Ltd Quthubullapur 6*10 Blister Mandal, Hyderabad Andhra Pradesh

Lopinavir (LPV) + A-42, MIDC HDPE Bottle 120, 200 mg + 50 mg Tablet Cipla Ltd. B Yes India Ritonavir (RTV) Patalganga Blister 10

Unit III 22 - 110, HDPE Industrial Alu/Alu Lopinavir (LPV) + 60, 120 200 mg + 50 mg Tablet Hetero labs limited A-B Yes development Area, India Blister Ritonavir (RTV) 10 Jeedimetla, Alu/PVC/PV Hyderabad dC blister

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 46/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Macleods Lopinavir (LPV) + Solan, Himachal 200 mg + 50 mg Tablet Pharmaceuticals A Yes India HDPE bottle 120 Ritonavir (RTV) Pradesh Limited HDPE Oral Boehringer 240ml + 83 Nevirapine (NVP) 10 mg / ml A Yes Roxane, Columbus, USA bottle+ Suspension Ingelheim 5ml syringe Cipla Ltd, Goa, India; Amber Meditab Specialties coloured Pvt Ltd, Maharashtra, 100ml, 240 Oral PET Bottle Nevirapine (NVP) 10 mg / ml Cipla Ltd. A Yes India; India Suspension Amber Indore, SEZ, 25ml, 10ml coloured Pithampur, Dist Dhar glass bottle (M.P.) Unit III Survey No. 313 and 314 Oral Aurobindo Pharma Bachupally 240ml Nevirapine (NVP) 50 mg /5 ml B Yes India HDPE bottle Suspension Ltd Quthubullapur 100ml Mandal, Hyderabad Andhra Pradesh Tablet 60, 1000 A-42, MIDC, HDPE bottle Nevirapine (NVP) 50mg for Oral Cipla Ltd. A-B Yes India Patalganga Blister Suspension 10 Sun Dispersible Paonta Sahib, Nevirapine (NVP) 50mg Pharmaceutical A Yes India HDPE bottle 60 tablet Himachal Pradesh Industries Ltd Unit III Survey No. Dispersible Aurobindo Pharma NDA 313 and 314 Nevirapine (NVP) 50mg B India HDPE bottle 30 tablet Ltd 22299 Bachupally Mandal, Telangana Plot No: S-155 to S- 159, Phase III, HDPE bottle 30,60,90 86 Nevirapine 50mg Tablet Microlabs Ltd A Yes Verna Industrial India Estate, Verna, Goa- Blister 10 403722

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 47/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Plot No: S-155 to S- HA570, 159, Phase III, HDPE bottle 60, Nevirapine 200mg Tablet Microlabs Ltd A-B ANDA Verna Industrial India 203080 Estate, Verna, Goa- Blister 10's 403722

Merck Sharp & Dohme USA Film-coated B. V. Waarderweg 39 China 91 Raltegravir 400mg Merck & Co, USA B Yes Bottle 60 tablet 2031 BN Haarlem Singapore Pays-Bas Netherlands

Unit III 22 - 110, Industrial 60, 120 Bottle Raltegravir 400mg Tablet Hetero labs limited B Yes development Area, India 10'sx10 Blister Jeedimetla, 10'sx14 Hyderabad

Merck Sharp & Dohme USA Chewable B. V. Waarderweg 39 92 Raltegravir 100mg Merck & Co, USA B Yes Bottle 60 tablet 2031 BN Haarlem China Pays-Bas

Merck Sharp & PATHEON PHARM child Granules for Dohme B. V. INC., 2110 East NDA resistant 60 Raltegravir ( Potassium) 100mg Oral Waarderweg 39 B Galbraith Road, USA 205784 single-use packets+kit Suspension 2031 BN Haarlem OH45237-1625 – foil packet Pays-Bas Cincinnati -USA

Merck Sharp & Dohme Chewable B. V. Waarderweg 39 93 Raltegravir 25mg Merck & Co, USA B Yes Netherland Bottle 60 tablet 2031 BN Haarlem Pays-Bas Oral 94 Ritonavir (RTV) 80 mg / ml AbbVie Ltd HA096 Yes Queenborough, Kent UK PET bottle 90ml Solution NDA A-42, MIDC, 95 Ritonavir (RTV) 25 mg Tablet Cipla Ltd. B India HDPE Bottle 60 205040 Patalganga Mylan Laboratories Sinnar, Nashik, Ritonavir (RTV) 25 mg Tablet A Yes India HDPE Bottle 30 Ltd Maharashtra

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 48/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA NDA A-42, MIDC, 96 Ritonavir (RTV) 50 mg Tablet Cipla Ltd. B India HDPE Bottle 60 205040 Patalganga Mylan Laboratories Sinnar,Nashik, HDPE Ritonavir (RTV) 100 mg Tablet A Yes India 30, 120 Ltd Maharashtra Bottle Ritonavir (RTV) 100 mg Tablet AbbVie Ltd HA491 Yes Luwigshafen, Germany HDPE Bottle 30, 60 A-42, MIDC, Ritonavir (RTV) 100 mg Tablet Cipla Ltd. A-B Yes India HDPE Bottle 30 Patalganga, Unit III, Survey No 51, Plot No 22-110 IDA, ANDA20 Ritonavir (RTV) 100 mg Tablet Hetero labs limited B Jeedimetla, India HDPE Bottle 30x1; 120x1 4587 Hyderabad, Telangana, 500 055 F.Hoffman-La 99 Saquinavir 500mg Tablet A Yes Madrid Spain HDPE Bottle 120 Roche 40mg/gm( Eq to Tenofovir Disoproxil 33mg/gm of Gilead Sciences, Takeda GmbH Germany 104 granule B Yes HDPE bottle 60g Fumarate Tenofovir Inc. Country Cork Ireland Disoproxil

Patheon Inc. Mississauga, Ontario Canada Tenofovir Disoproxil Tablet Film Gilead Sciences, HDPE 105 300mg B Yes Nycomed Oranienburg Germany 30 Fumarate coated Inc. container GmbH Granta Park UK Abington, Cambridge

Tenofovir Disoproxil Plot No. L-147, L147-1, 300 mg Tablet Cipla Ltd. A - B Yes India HDPE bottle 30, 1000 Fumarate Verna Goa Sun Tenofovir Disoproxil Paonta Shahib, 300mg Tablet Pharmaceutical A Yes India HDPE Bottle 30 Fumarate Himachal Pradesh Industries Ltd HDPE Tenofovir Disoproxil Mylan Laboratories Sinnar,Nashik, 30,100; 300 mg Tablet A - B Yes India Bottle; Fumarate Ltd Maharashtra 2*10 Blister

36/7, Tenofovir Disoproxil Strides Arcolab Suragajakkanahalli HDPE Bottle 30 300 mg Tablet A-B Yes India Fumarate Limited Indlavadi cross Anekal Blister 10 Taluk Bangalore

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 49/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA

Unit - III Survey No. 313 & 314, Bachupally, Quthubullapur Tenofovir Disoproxil Aurobindo Pharma Mandal Hyderabad, 300 mg Tablet B Yes India HDPE bottle 30, Fumarate Ltd Andhra Pradesh Unit-VII (SEZ), Mahaboob Nagar (DT), Andhra Pradesh

Unit III 22-110 Industrial Tenofovir Disoproxil 30, 60, 100, 300 mg Tablet Hetero labs limited A-B Yes development Area India HDPE Bottle Fumarate 500, 1000 Jeedimetla, Hyderabad Aspen Port Elizabeth , HA588 (Pty) Ltd, Korsten Port Tenofovir Disoproxil 300 mg Tablet Pharmacare Ltd. A-B ANDA Elizabeth, South Africa HDPE Bottle 30 Fumarate 203470 South Africa

(Unit-2), Plot No:19, 20 & 21, Western Sector, APSEZ, Tenofovir Disoproxil Laurus Labs 300 mg Tablet A HA679 Atchutapuram India HDPE Bottle 30x1, 500x1 Fumarate Limited Mandal,Visakhapatna m-District, Andhra Pradesh, 531011 Macleods Tenofovir Disoproxil Kachigam, Daman 300 mg Tablet Pharmaceuticals A Yes India HDPE bottle 30, Fumarate Baddi, H.P. Limited PVC/PVdC/ 10x10 106 Zidovudine 60mg Tablet Microlabs Ltd A Yes South Africa India Alu blister 60, 100, HDPE bottle 500, 1000 Sun Dispersible Paonta Shahib, HDPE 107 Zidovudine 60mg Pharmaceutical A Yes India 60 Tablet Himachal Pradesh Bottle Industries Ltd

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 50/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Infusion Barnard Castle, 108 Zidovudine 10mg/ml ViiV HealthCare A Yes UK Glass vial 20ml solution County Durham Macleods Solan, Himachal 100ml, Zidovudine 10mg/ml Oral solution Pharmaceuticals A Yes India HDPE Bottle Pradesh 240ml Limited 109 Zidovudine 50mg/5ml Oral solution ViiV HealthCare A Yes Mississauga, Ontario Canada PET bottle 200ml Unit-III, Jeedimetla, Zidovudine 50mg/5ml Oral solution Hetero labs limited A Yes Hyderabad, Andhra India HDPE Bottle 240ml Pradesh, India Cipla Limited L-139 to HDPE 100ml, L-146, Verna Goa, Zidovudine 50mg/5ml Oral solution Cipla Ltd. A - B Yes India bottle; 240ml Meditab Specialities PET Bottle 100ml; Ltd Unit III Survey No. HDPE 313, Bachupally, bottle, with Aurobindo Pharma Zidovudine 50mg/5ml Oral solution B Yes Quthubullapur India dose 240ml Ltd Mandal, Hyderabad, delivery Andhra Pradesh device Mylan Laboratories Sinnar,Nashik, 110 Zidovudine 100mg Tablet A - B Yes India HDPE Bottle 60 Ltd Maharashtra L138-147 L150 s103- 105 VernaGoa; 111 Zidovudine 100mg Capsules Cipla Ltd. A - B Yes Indore, SEZ, India HDPE Bottle 100; 1000 Pithampur, District Dhar (M.P.) S.C. Europharm, Bottle 100; Zidovudine 100mg Capsules ViiV HealthCare A Yes Romania Brasov Blister 100 S. C. Europharm, 112 Zidovudine 250mg Capsules ViiV HealthCare A Yes Romania Blister 40 Brasov Unit-III, 22-110, Industrial 60, 500, Zidovudine 300mg Tablets Hetero labs limited A-B Yes Development Area, India HDPE bottle 600 Jeedimetla, Hyderabad

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 51/52 WHO Global International Non- Supplier/ Prequalifi Ref.N Strength/ Dose Dosage form Fund QA Manufacturing site Country Material Pack proprietary name Manufacturer(s) cation/ o Standard SRA Glaxo Operations UK, Ltd, Ware, Hertfordshire, UK; UK Bottle 28 Zidovudine 300mg Tablets ViiV HealthCare A Yes Glaxo Wellcome SA, Blister 28, 60; Aranda (packaging and release), Spain Sun HDPE Paonta Sahib, 60; Zidovudine 300mg Tablets Pharmaceutical A -B Yes India bottle; Himachal Pradesh 10, 8 Industries Ltd Blister HDPE Mylan Laboratories Sinnar,Nashik, 56, 60; Zidovudine 300mg Tablets A -B Yes India bottle; Ltd Maharashtra 2 x 10 Blister HDPE 30, 60, Plot No. L-147, L147-1, Zidovudine 300mg Tablets Cipla Ltd. A - B Yes India Bottle; 1000 ; Verna Goa Blister 10 PVDC/PVC/ 10; Zidovudine 300mg Tablets Microlabs Ltd A yes Verna, Goa India Alu blister; 30, 60, 90 HDPE bottle A raltegravir (RAL)-based regimen may be recommended as an alternative first-line regimen for infants and children for whom approved DTG dosing is not available titulaire AMM release center End of A or B products List

Edition: Version 163,14 July 2021 List of AIDS drugs classified according to the GF QA Policy 52/52 List Of ARV Pharmaceutical Products classified according to the Global Fund Quality Assurance Policy

Edition: Version 163- 14 July 2021 List of ERP ( Expert Review Panel) Reviewed Products which are permitted for time limited procurement:

If there is no or only one A or B product available ( supply of the product cannot be done within 90 days after the receipt of the Purchase Order by the manufacturer) , grant funds may be used to procure a ERP reviewed product eligible for procurement for limited time (12 months) period. The PR must send the “notification form” (available at https://www.theglobalfund.org/media/5863/psm_notification_form_en.doc) to the Global Fund and upon receiving the “ No Objection” letter form the Global Fund, the procurement can proceed. Please note that the QC test of the selected ERP product will be performed by the Global Fund.

Global Period International Non- Dosage Supplier/ Ref. Strength/ Dose Fund QA Validity for Manufacturing site Country Material Pack proprietary name form Manufacturer(s) No Standard ERP Review

Unit – III (Formulations), ERP # 22 – 110, I.D.A, HDPE Darunavir + Ritonavir 400mg + 50mg tablet FDC Hetero Labs Limited 23-08-2021 India 30, 60, 120 Reviewed Jeedimetla, Container Hyderabad, Telangana 500 055 End of ERP Reviewed products list

Edition: Version 163, 14 July 2021 List of AIDS drugs classified according to the GF QA Policy 1/1