RIVASTIGMINE
PHARMACOMPASS MARKET OVERVIEW
PharmaCompass.com New Delhi: [email protected] Paris: [email protected] Overview
Rivastigmine (sold under the trade name Exelon) is a parasympathomimetic or cholinergic Agent. Synonyms: Exelon™, Rivastigmine tartrate , Rivastach® Patch, Prometax®, SDZ ENA 713
Chemical Name: (S)-3-[1-(dimethylamino)ethyl]phenyl N-ethyl-N-methylcarbamate PRODUCTPATENT OVERVIEW& NEWS Therapeutic Indication: It is used for the treatment of mild to moderate dementia of the AND Alzheimer's type and dementia due to Parkinson's disease. Originator: Novartis PATENT IN Originator Market: The United States THE U.S. Developer: Novartis; Ono Pharmaceutical
Patent in the US Novartis’ Exelon has 6 patents for Transdermal Patch (Extended Release) which are set to expire in Jan 2019 Related news and articles
• The Hague District Court rejected Novartis’ claim based on infringement of its patent for patches containing rivastigmine against Alvogen and Focus Farma because the patent was invalid- July 7, 2016
Novartis AG is co-owner of EP 2 292 219 B1 (EP 219), granted on 12 June 2013. EP 219 relates to a “Transdermal therapeutic system for the administration of rivastigmine”
PATENT & NEWS • Novartis has been battling generic-drug makers over the Exelon patch patents in multiple suits over GLOBAL NEWS the past few years:- November 6, 2015 (i) Novartis and LTS Lohmann Therapie-Systeme AG claim Dr. Reddy’s and Amneal and its New York and India subsidiaries infringed two patents associated with Exelon (ii) The brand name drugmaker sued Par Pharmaceuticals and Watson Lab. over the Exelon patch patents in 2013 (iii) A judge ruled that Watson infringed the patents in its ANDA in June 2014 and Par settled, only to go to trial later (iv) After beating Watson, Novartis took on Mylan Pharmaceuticals in June 2014 as well (v) Zydus Pharma (USA) also got slapped with an Exelon suit in 2014, but it was thrown out for lack of jurisdiction in August Patch Alvogen Launches the First Generic Exelon® Patch in the United States market - September 04, 2015
Sandoz launches authorized generic version of Exelon® Patch GENERIC in the United States market - September 2, 2015 LANDSCAPE U.S. MARKET Capsules
Sun Pharma introduces generic rivastigmine capsules in the United States market- July 2, 2010
Dr. Reddy’s announces the launch of Rivastigmine Tartrate Capsules in the United States market - September 22, 2011
Generic overview: detailed description here PRODUCT SALES INFORMATION Exelon® Patch is the first and only patch to treat all stages of Alzheimer's disease U.S. MARKET Sales 2011 from IMS data EXELON®* brand and generic Rivastigmine tartrate had U.S. sales of approximately $92.6 million for the most recent twelve months ending June 2011. Sales Data from U.S. Medicare Prescription Payment in 2013
DRUG NAME GENERIC NAME BENEFICIARIES PRESCRIPTIONS CLAIMS TOTAL DRUG COST Capsules generics are Exelon Rivastigmine Patch 235,060 78,098 1,381,768 $465,772,265.79 Exelon Rivastigmine Tartrate Capsules 1,092 1,129 3,704 $1,395,838.32 on the rise Rivastigmine Rivastigmine Tartrate Capsules 51,762 36,189 333,686 $54,729,264.75 Sales 2014 from IMS data Novartis’s Exelon® patch, delivered sales of approximately $400 million USD in the United States during 2014. Market Size : $ 26.7 million global sales of Rivastigmine in 2015 (as per IMS Data) Sales Data from Annual Reports 2015
Market share: 9 % 2014 REVENUE 2015 REVENUE IN SALES DIFFERENCE IN COMPANY PRODUCT ACTIVE MAIN THERAPEUTIC GROWTH IN MILLIONS MILLIONS MILLIONS NAME NAME INGREDIENT INDICATION (%) As per U.S. Medicare Prescription (2013): (USD) (USD) (USD) Exelon Caps/ Neuroscience and Capsules sales : 11 % Novartis Rivastigmine 1,009 728 -281 -28% Patch Sales: 89 % Exelon Patch Mental Health S. COMPANY NAME COUNTRY ACTIVE INGREDIENTS US DMF CEP/ WRITTEN COMPLIANCE NO. ALL COMBINED COS CONFIRMATION ISSUES 1 Aarti Drugs Ltd India Rivastigmine Hydrogen Tartrate Filed ( 2009) - Issued (2013) Import Alert (23-3-2015) GLOBAL 2 Actavis Group Ptc Ehf Ireland Rivastigmine Hydrogen Tartrate Filed ( 2009) - - - 3 Alembic India Rivastigmine Filed ( 2015) Issued (2015) Issued (2013) - Pharmaceuticals Ltd API SUPPLIER Rivastigmine Tartrate Filed ( 2008) - - - Rivastigmine Hydrogen Tartrate - Issued (2014) - -
LANDSCAPE 4 Apotex Pharmachem Inc Canada Rivastigmine Filed ( 2015) -- Warning Letter Rivastigmine Tartrate Filed ( 2008) - (30/01/15) 5 Aurobindo Pharma Ltd India Rivastigmine Filed ( 2015) - Rivastigmine Tartrate Filed ( 2010) - - - Rivastigmine Hydrogen Tartrate - Issued ( 2015) - - Regulatory Filings 6 Cadila Healthcare Ltd India Rivastigmine Filed ( 2013) - Issued (2013) -
(US DMF, CEP/COS, 7 Cambrex Karlskoga Ab United Rivastigmine Filed ( 2015) Issued (2016) - - States EU Written Confirmation) Rivastigmine Hydrogen Tartrate - Issued (2016) - - 8 Centaur India Rivastigmine Hydrogen Tartrate - - Issued (2016) - Pharmaceuticals Rivastigmine Hydrogen Tartrate [1/3] 9 Cipla Ltd India Filed ( 2003) Issued (2015) Issued (2013) - 10 Dr Reddys Laboratories India Rivastigmine Filed ( 2012) - Issued (2013) Warning Ltd Letter (11/05/15) Rivastigmine Tartrate - - Issued (2016) - Rivastigmine Hydrogen Tartrate Filed Issued (2015) Issued (2016 - ( 2004) (2008) S. COMPANY NAME COUNTRY ACTIVE INGREDIENTS US DMF CEP/ WRITTEN COMPLIANCE NO. ALL COMBINED COS CONFIRMATION ISSUES
11 Erregierre Spa Italy Rivastigmine Filed ( 2011) - - - GLOBAL Rivastigmine Tartrate Filed ( 2007) - - - 12 Excella Gmbh De 90537 Germany Rivastigmine - Issued (2015) - - Feucht API SUPPLIER 13 Interquim Sa Spain Rivastigmine Filed ( 2009) Issued (2015) - -
Rivastigmine Hydrogen - Issued (2015) - - LANDSCAPEGLOBAL Tartrate 14 Jubilant Generics Ltd India Rivastigmine Filed ( 2011) - - - API Supplier Rivastigmine Tartrate Filed ( 2011) - - - 15 Macleods India Rivastigmine Tartrate Filed ( 2010) - - - Landscape Pharmaceuticals Ltd 16 MSN Organics Private India Rivastigmine Filed ( 2015) - - - Regulatory Filings Ltd Rivastigmine Tartrate Filed ( 2014) - - -
(US DMF, CEP/COS, Rivastigmine Hydrogen - Issued (2016) - - with DMF & COS Tartrate EU Written Confirmation) 17 Mylan Laboratories Ltd United Rivastigmine Filed Issued (2015) Issued (2013) - [2/3] States ( 2010) (2012) Rivastigmine Tartrate Filed ( 2010) - - [2/3] Rivastigmine Hydrogen - Issued (2014) Issued (2013) Tartrate 18 Nuray Chemicals Pvt. India Rivastigmine Hydrogen - - Issued (2014) - Ltd., Tartrate S. COMPANY NAME COUNTRY ACTIVE INGREDIENTS US DMF CEP/ EU WRITTEN COMPLIANCE NO. ALL COMBINED COS CONFIRMATION ISSUES GLOBAL 19 Orchid Chemicals And India Rivastigmine - - Issued (2013) - Pharmaceuticals Ltd API SUPPLIER Rivastigmine Tartrate Filed ( 2007) - Issued (2013) - GLOBAL 20 Shodhana Laboratories India Rivastigmine - - Issued (2013) - Ltd. LANDSCAPE Rivastigmine Hydrogen - - Issued (2013) - API Supplier Tartrate 21 Sun Pharmaceutical India Rivastigmine Tartrate Filed ( 2004) - Issued (2013) - Industries Ltd Landscape 22 Zhejiang Jiuzhou China Rivastigmine - Issued - - Pharmaceutical Co., Ltd. (2015) CN 318 000 Taizhou City Regulatory Filings (USwith DMF, DMF CEP/COS & COS and Conclusion: Total API Suppliers= 22 API Suppliers for : EU Written[3/3 Confirmation)] India # 14 (i.e. more than 50%) United States # 2 Canada # 1 [3/3] China # 1 Germany # 1 Italy # 1 Ireland # 1 Spain # 1 Other Suppliers in various databases Rivastigmine Bioiberica S.A (CPHI China Exhibitor Product List) Hangzhou Read Chemical Co.,Ltd. (CPHI China Exhibitor Product List) Hubei Lansun Biochemistry Pharmaceutical Co., Ltd. (CPHI China Exhibitor Product List) Interquim, S.A. *(New Zealand Database) Mylan Laboratories Limited *(New Zealand Database) Novartis Pharma AG *(New Zealand Database) GLOBAL Novartis Ringaskiddy Ltd *(New Zealand Database) API SUPPLIER Shenzhen Oriental Pharmaceutical Co., Ltd. (CPHI China Exhibitor Product List) Rivastigmine Tartrate LANDSCAPE Alembic Pharmaceuticals Limited, Unit I (Mexico COFEPRIS Database ) Bharat Pharma (Product List) BOC Sciences (Product List) Cipla Ltd (New Zealand Database) Dalian Wondersun Biochemical Technology Co,.Ltd (CPHI China Exhibitor Product List) Globe Quimica Ltda (Product List) Hangzhou Neway Chemicals Co.,Ltd (CPHI China Exhibitor Product List) Others Langfang Gaobo Jingband Pharmaceutical Co.,Ltd. (CPHI China Exhibitor Product List)
Rivastigmine Hydrogen Tartrate Aarti Drugs Limited Cipla Ltd (Iran API Registration ) Interquim (Iran API Registration ) Sun Pharmaceutical (Iran API Registration )
* Manufacturer for both Rivastigmine and Rivastigmine Tartrate COMPANY NAME (SUPPLIERS) COUNTRY CUSTOMERS IN EGYPT
Aarti Drugs Limited India Al Esraa Pharmaceutical Optima-egypt Dr Reddy's Laboratories Ltd India Global NAPI Pharmaceuticals (GNP), Hikma pharma Emcure Pharmaceutical Limited India Global NAPI Pharmaceuticals (GNP) EGYPT MARKET Interquim S.A-spain Spain Eva pharma for Pharmaceuticals and Medical Appliances Arab Company for Pharmaceuticals & Medicinal Plants Mahavir Laboratories Private Ltd India CUSTOMERS SUPPLIERS (Mepaco- Medi Food) LANDSCAPE MSN Organics P Ltd India universal pharmceutical industries (unipharma) Mash Company For Pharmaceutical Industries Shodhana Laboratories Ltd India (Mash Premiere) Sun Pharmaceutical Industries-india India Eva pharma for Pharmaceuticals and Medical Appliances Mash Company For Pharmaceutical Industries Shanghai Daishang Chemical Co.,Ltd-china China (Mash Premiere) Mash Company For Pharmaceutical Industries Zhengzhou Sigma Chemical Co.Ltd-china China (Mash Premiere) Mash Company For Pharmaceutical Industries Zhiyu Biotechnology Co,ltd-china China Commercial opportunity (Mash Premiere) for Multinational Conclusion: Pharmaceutical Companies • Egypt' s pharmaceutical and healthcare sector presents a high-risk investment opportunity for international drug makers • Egypt finished dosage formulators import API majorly from India and China API Imports to India from Jan 2015- Mid 2016
COMPETITOR Major destinations from where API has been Imported are :
ANALYSIS QUANTITY AVG. PRICE Imported by Zydus Cadila from Spain IMPORTING PORT CIF ($) (KGS) ($/KGS) (Highly possibility that the supplier is Interquim)
Spain 5.5 44,455.0 8,082.7 Ahmedabad 5.5 44,455.0 8,082.7 Slovak Republic 1.0 3,349.0 3,349.0 API Trade Mumbai Air 1.0 3,349.0 3,349.0 Imported by Rusan Pharma from Statistics Slovak Republic (Highly possibility that the supplier is Saneca)
[1/2] The United States 16.2gms of API was imported for USD 132,475. Possible suppliers can be Mylan US or Cambrex Karlskoga France From Jan 2015- Mid 2016, 11gms of API was imported for USD 9,844 Less than 10 Kg API has been imported into India API Exports of India from Jan 2015- Mid 2016 Major destinations where API has been exported are :
EXPORTING PORT QUANTITY AVG. PRICE CIF ($) From Jan 2015-Mid 2016; DESTINATION IN INDIA (KGS) ($/KGS) Seoul - Incheon Int' 1,027 3,904,116 3,801.5 Total Export Of API - 2,653 Kg/ USD 9,650,590 Mumbai Air 999 3,767,068 3,771.2 Hyderabad Air 24 123,926 5,163.6 Export of different salts of API mentioned below- Ahmedabad 4 13,122 3,200.5 COMPETITOR Boston - Logan, Ma 591 1,897,779 3,206.3 Rivastigmine: 2,090 Kg/ USD 7,261,356 Mumbai Air 591 1,897,779 3,206.3 Rivastigmine Tartrate: 368 Kg/ USD 1,320,979 Philadelphia 421 1,346,487 3,196.6 Rivastigmine Hydrogen Tartrate: 198 Kg/ USD 1,068,947 ANALYSIS Mumbai Air 421 1,346,487 3,196.6 Guarulhos 221 732,501 3,314.5 Ahmedabad 120 383,935 3,199.5 API exported by Mumbai - 2,375 Kg/ USD 8,648,618 Mumbai Air 101 348,566 3,451.1 Reykjavik 85 297,485 3,499.8 . Mylan (Mumbai) exported 814 Kg/ USD 2,625,032 Mumbai Air 47 159,164 3,386.5 . Other exports are of Oceanic Pharmachem Ahmedabad 38 138,321 3,640.0 Tehran 71 255,219 3,594.1 [104 Kg/ 400891] and Cipla based on transaction data API Trade Mumbai Air 71 255,219 3,594.1 . Centaur Pharma, Macleods , Sun Pharmaceuticals can be other possible suppliers from Mumbai Statistics Exported by Emcure to Marham Daru, Iran Alembic Pharmaceuticals exported 197 Kg/ USD 660,215 API from Ahmedabad as per the transaction data [2/2] Hyderabad exported 67 Kg/ USD 309,044 API ; possible supplier can be Aurobindo Pharma, MSN organic, Hetero Drugs, Shodhana Laboratories as per the transaction data Bangalore exported 14 Kg/ USD 32,713 API
Conclusion: API export of India (2,552Kgs) has been almost 365 times compare to the API import (7Kgs) to India FDF Imports to India from Jan 2015- Mid 2016
Major destinations from where FDF has been imported are:
IMPORTING PORT CIF ($) DESTINATION IN INDIA From Jan 2015-Mid 2016; USD 2,003,303 FDF has been imported
Spain 1,162,336 Transdermal Patch Capsules Bombay Air Cargo 881,879 USD1,804,522 USD198,781 COMPETITOR Mumbai Air 280,457 Germany 600,371 Rivastigmine Transdermal patch was imported by Novartis India, ANALYSIS Mumbai Air 600,371 Possible supplier from Spain can be Novartis Farmaceutica as per the Iceland 198,781 list of Imported finished formulation (registered) (June 2014- Dec. 2014 Chennai Air Cargo 187,578 which is valid till 2017) issued by CDSCO (India) Chennai Air 11,203 Japan 21,256 Rivastigmine capsules was imported by Novartis India, Bombay Air Cargo 16,912 Possible supplier from Germany can be M/S Lts Lohmanni as per the list of Imported finished formulation (registered) (June 2014- Dec. 2014 FDF Trade Ahmedabad 4,344 which is valid till 2017) issued by CDSCO (India) United States 20,329 Statistics Mumbai Air 20,329 France 230 Actavis Pharma Development Centre (Chennai) imported Capsules from Bangalore Air 230 Iceland [1/2] GRAND TOTAL 2,003,303 Mumbai imported USD 1,799,948 Exelon Patch
Lupin and Cliantha Research, India are among the few importers who imported Rivastigmine Transdermal Patch from Japan Sidmak Laboratories, India imported USD 4,170 Exelon patch from the United States FDF Exports of India from Jan 2015- Mid 2016 Major destinations from where FDF has been exported:
EXPORTING PORT CIF ($)
Chicago, Il 2,647,080 From Jan 2015-Mid 2016; USD 8,112,264 FDF has been exported Detroit Mi 1,547,854 Miami, Fl 992,421 Capsules Patch Prague - Ruzyne 672,825 USD 8,112,109 USD 155 COMPETITOR Wixom 632,110 Kuala Lumpur 397,471 ANALYSIS Helsinki 230,798 Mumbai exported USD 6,155,118 capsules Brownsburg 168,451 Hyderabad exported USD 1,937,414 capsules Chicago 146,005 Ahmedabad exported USD 7,400 capsules London Metropolitan 111,544 Stuttgart 106,071 Summary of FDF exports of India: FDF Trade Mylan Laboratories, India exported USD 437,033 Rivastigmine Capsules to Medis International A S, Serbia Mind (Torrent Pharmaceuticals), India exported USD 429,979 capsules (Brand Name: Rivadem) Statistics Macleods Pharmaceuticals, India exported USD 343,710 capsules to Macleods Pharmaceuticals USA as per the transaction data Sun Pharmaceuticals, India exported USD 266,480 capsules (Brand Name: Rivamer and Rivastigmine Tartrate) Torrent Pharmaceuticals, India exported USD 230,798 capsules (Brand Name: Rivastigmin Orion) to Orion [2/2] Corp, Finland Dr. Reddy, India exported USD 1,612,049 capsules to Dr. Reddy’s, United States Pharmascience exported USD 19,194 capsules (Brand Name: PMS- rivastigmine) Zydus exported USD 18,274 capsules out of India
Conclusion: India exported USD 8,112,264 FDF which is almost 4 times compare to the FDF import (USD 2,003,303) COMPANY NAME COUNTRY WEBSITE Genericon Pharma Gesellschaft M.B.H Austria http://www.genericon.at/ STADA Arzneimittel Gmbh Austria http://www.stada.at/unternehmen/stada-arzneimittel-gmbh/ Enestia Belgium N.V / S.A. Belgium http://www.sharpservices.com/ Eurogenerics N.V Belgium http://www.eg.be/nl Novartis (Bangladesh) Ltd. Bangladesh Sun Pharmaceutical (Bangladesh) Ltd. Bangladesh http://www.sunpharma.com/ Apotex Inc Canada http://www.apotex.com/global/default.asp Generic Medical Partners Inc Canada http://www.gmprx.com/Site/Home.html Mint Pharmaceuticals Inc Canada http://www.mintpharmaceuticals.com/English/index.php Novopharm Ltd Canada https://www.tevacanada.com/default.aspx Pharmascience Inc Canada http://www.pharmascience.com/home GLOBAL Pro Doc Limitee Canada http://www.prodoc.qc.ca/ S & D Pharma CZ , Spol . S.R.O Czech Republic http://www.sdpharma.cz/ Orifarm Generics A / S, Denmark Denmark http://www.orifarm.com/ FINISHED DOSAGE Pharmacodane Aps Denmark http://pharmacodane.dk/ Al Esraa Pharmaceutical Optima Egypt http://esraapharma.com/hcp/ Eva Pharma For Pharmaceuticals And Medical Appliances Egypt http://www.evapharma.com/ FORMULATORS Mash Company For Pharmaceutical Industries Egypt http://www.mashpharma.com/ Mepaco-medifood Egypt http://www.mepaco-pharma.net/ Unipharma Co. Egypt http://www.unipharma-eg.com/ Western Pharmaceuticals Industries Egypt http://www.western-pharmaceutical.com/index.html [1/5] Delpharm Huningue SAS France http://www.delpharm.com/Delpharm-Huningue Laboratoires Plasto Sante France http://www.plastopharma.com/ TEVA Santé France http://www.teva-france.fr/Pages/default.aspx Zydus France France http://www.zydusfrance.com/ ACC Gmbh Analytical Clinical Concepts Germany http://www.accgmbh.com/en/index.html Aliud Pharma Gmbh & Co. Kg Germany http://www.aliud.de/ AMW Gmbh Germany https://a-m-w.eu/en/ Betapharm Arzneimittel Gmbh Germany http://www.drreddys.com/germany/dr-reddys-in-germany.aspx Genus Pharmaceuticals Ltd Germany http://www.thorntonross.co.uk/ Hexal AG Germany http://www.hexal.de/ Lek Pharmaceuticals D.D Germany http://www.lek.si/en/ Lts Lohmann Therapie Systeme Ag Germany http://www.ltslohmann.de/en/home.html Merckle GMBH Germany http://www.merckle.de/ Neuraxpharm Arzneimittel Gmbh Germany http://www.neuraxpharm.de/html-de/start.php COMPANY NAME COUNTRY WEBSITE Novartis Pharma Gmbh Germany https://www.novartis.de/ PHAST Society For Pharmaceutical Quality Standards Mbh Germany http://www.phast.com/index.html Salutas Pharma Gmbh Germany http://www.sandoz.de/salutas/ Stada Arzneimittel Ag Germany https://www.stada.com/start.html Torrent Pharma Gmbh Germany http://www.torrentpharma.com/int_europe.php Welding Gmbh & Co. Kg Germany http://welding.eu/en/ Winthrop Arzneimittel Gmbh Germany https://www.zentiva.de/ Genepharm Sa Greece http://www.genepharm.gr/en/ Global Napi Pharmaceuticals Greece http://www.globalnapi.com/ Heumann Pharma Gmbh & Co. Generica KG Greece https://www.heumann.de/ Kleva Pharmaceuticals SA Greece GLOBAL Lavipharm SA Greece http://www.lavipharm.gr/ Pharmanel Pharmaceuticals SA, Greece http://www.pharmanel.gr/ Pharmathen Greece http://www.pharmathen.com/home/home-27.htm?lang=en FINISHED DOSAGE Specifar S.A Greece http://www.specifar.gr/ Vianex S.A Greece http://www.vianex.gr/ Mylan Hungary Kft. Hungary http://www.mylan.co.hu/hu-hu/kapcsolatfelvetel-mylan FORMULATORS Actavis Group PTC Ehf Iceland http://www.actavis.co.uk/en-gb/home Aurochem Pharmaceuticals (India) Pvt. Ltd India http://www.aurochemlaboratories.com/ Alembic Pharmaceuticals Limited India Cipla Ltd India http://www.cipla.com/en/ [2/5] Mylan Laboratories Limited India http://www.mylan.in/ Orchid Healthcare (Una División De Orchid Chemicals & Pharmaceuticals Ltda.) De India India http://www.orchidpharma.com/Default.aspx Veros Healthcare Pvt . Ltd . De India India http://www.verospharma.com/ Mcdermott Laboratories Limited Ireland http://www.mylan.ie/en-ie/contact-mylan Suir Pharma (Formerly A Stada AG Manufacturing Site) Ireland http://www.suirpharma.com/ Jeil Pharmaceutical Co., Ltd. Korea https://www.jeilpharm.co.kr/eng/ Myungmoon Pharm. Co., Ltd Korea http://www.mmpharm.co.kr/ APL Swift Services (Malta) Limited Malta http://www.aurobindo.com/ Milpharm Limited Malta http://www.aurobindo.com/ Centrafarm Services B.V. Netherlands http://www.centrafarm.nl/ Focus Farma Netherlands http://www.focusfarma.nl/ http://www.tevapharm.com/teva_worldwide/europe/teva_in_net Teva Pharma B.V Netherlands herlands/ COMPANY NAME COUNTRY WEBSITE Tjoapack Netherlands BV Netherlands http://tjoapack.com/ Douglas Pharmaceuticals (Fiji) Limited New Zealand http://www.douglaspharmaceuticals.com/en/ Douglas Manufacturing Ltd New Zealand http://www.douglasmanufacturing.co.nz/en/ ICN Polfa Rzeszów S.A. Poland http://www.icnpolfa.pl/en Jelfa SA Poland http://www.valeant.eu/contact/jelfa-sa Pabianice Polfa SA Poland http://med-interplast.com/producers/10.html Teva Operations Poland Sp . Z O.O. Poland http://www.teva.pl/Pages/default.aspx Valeant Sp. Z O.O. Sp. J. Poland http://www.valeantinfo.pl/en http://www.atlasdasaude.pt/publico/content/farma-aps-produtos- Farma-aps Pharmaceuticals, SA Portugal farmaceuticos-sa GLOBAL S.C. Rompharm Company S.R.L. Romania http://www.rompharm.ro/ HBM Pharma S.R.O. Slovak Republic http://www.hbmpharma.eu/en/main/index FINISHED DOSAGE Krka, D. D., Novo Mesto slovenia https://www.krka.biz/en/ Cinfa Laboratories, Sa Spain http://www.cinfa.com/cinfa/home/inicio.aspx Kern Pharma Spain http://www.kernpharma.com/en FORMULATORS Laboratorios Medicamentos Internacionales S.A Spain http://www.medinsa.es/ Laboratorios Vir S.A. Spain http://vir.es/index.php/en/ Labosuan Spain http://www.labosuan.com/en/ Lacer S.A Spain http://www.lacer.es/wps/portal/wp/lacer [3/5] Novartis Farmacéutica, S.A Spain https://www.novartis.es/ Acino Ag Switzerland http://www.acino-pharma.com/html/index.php?id=1&L=1 Novartis Pharma-switzerland Switzerland https://www.novartis.com/ Novartis (Thailand) Ltd Thailand www.th.novartis.com World Medicine Ilac San Ve Tic LTD Stl Turkey http://www.worldmedicinegroup.com/ Bristol Laboratories Limited United Kingdom http://www.bristol-labs.co.uk/ Generics [UK] Ltd United Kingdom http://www.mylan.co.uk/ Hikma Pharma United Kingdom http://www.hikma.com/en/index.html Nicobrand Limited United Kingdom http://www.nicobrand.com/ Rosemont Pharmaceuticals Ltd United Kingdom https://www.rosemontpharma.com/ Watson Labs [NDC No. 0591-3208-60] is getting the USFDA approved product manufactured in India by Cipla based on the Label
GLOBAL FINISHED DOSAGE FORMULATORS
Alvogen is getting the USFDA approved product [4/5] manufactured in Germany by Acino AG on the basis of NDC No. 47781-304-03 (mentioned on Medlibrary) GLOBAL Breckenridge Pharmaceutical [NDC No. 51991-793-33] is FINISHED DOSAGE getting the USFDA approved product manufactured in India by Alembic Pharmaceuticals based on the Label FORMULATORS
Sun Pharmaceuticals Industries, US [5/5] [NDC 62756-145-86] is getting the USFDA approved product manufactured in India by Sun Pharmaceuticals India based on the label NO GENERICS PRESENT IN BELOW MENTIONED COUNTRIES Arab Emirates, Bahrain, China, Costa Rica, Colombia, Lebanon, Mexico, Saudi Arabia, Singapore, Sudan, Taiwan
NOT LAUNCHED IN BELOW MENTIONED COUNTRIES OPPORTUNITIES Guatemala, Vietnam
TO OPPORTUNITY FOR API MANUFACTURER IN MENTIONED COUNTRIES CONSIDER MEXICO Alembic Pharmaceuticals Limited, Unit I is the only API manufacturer IRAN Cipla, Interquim and Sun Pharmaceutical are the API manufacturer JAPAN No JPDMF fillings