100th UAC Meeting (21.12.2018) VISAKHAPATNAM TABLE AGENDA FOR 101th UNIT APPROVAL COMMITTEEs MEETING FOR THE SEZs LOCATED IN VSEZ & OTHER PRIVATE SEZs OF ANDHRA PRADESH REGION TO BE HELD ON 22.01.2019 AT 11.00 A.M. AT CONFERENCE HALL, 3RD FLOOR, VUDA, UDYOG BHAWAN COMPLEX, SIRIPURAM, VISAKHAPATNAM. Sl. TABLE AGENDA/SUPPLIMENTARY AGENDA Page No No. 1 Table Agenda Item No. 01: Request of M/s. Quantum Clothing India Pvt. Ltd., 2 unit in M/s. Brandix India Apparel City Pvt. Ltd. SEZ for inclusion of manufacturing and trading activity under broad-banding in LOA. 2 Table Agenda Item No. 02 : Request of M/s. Aurobindo Pharma Limited, unit in 2-3 APIIC, Multiproduct SEZ for inclusion of additional product under broad-banding in LOA. 3 Table Agenda Item No. 03: Request of M/s. Honour Lab Limited, unit in M/s 3-4 Hetero Infrastructure Ltd, SEZ for inclusion of additional product under broad- banding in LOA 4 Table Agenda Item No. 04 : Request of M/s. GVK Biosciences Pvt. Ltd., unit in 4-5 M/s Ramky Pharma City SEZ, Parawada, Visakhapatnam for inclusion of additional product under broad-banding in LOA. 5 Table Agenda Item No. 05 : Request of Dr. Reddy Laboratories Ltd, Formulations 5-6 Tech Ops-IX for Inclusion of QC/QA related services as part of the LoA for extending to all without restriction –request for broad banding of LoA to include services 6 Table Agenda Item No. 06 : Request of M/s. Rashmita Information Systems Pvt. 6 Ltd LoA No.9/SEZ/301/VSEZ/2015 dt.9.09.2012 – Request for Extension of the validity of LoA 7 Table Agenda Item No. 07 : Request M/s. Worldwide Sorting Private Limited for 6-7 inclusion of HSN Codes for the authorized Activity in LoA Letter No.9/SEZ/302/VSEZ/2016 dt.16.08.2017 1 100th UAC Meeting (21.12.2018) VISAKHAPATNAM TABLE AGENDA Table Agenda Item No. 01: Request of M/s. Quantum Clothing India Pvt. Ltd., unit in M/s. Brandix India Apparel City Pvt. Ltd. SEZ for inclusion of manufacturing and trading activity under broad-banding in LOA. M/s Quantum Clothing India Pvt. Ltd., vide letters dt. 11.12.2018 has requested for inclusion of Trading Activity in the LoA as per the change in business model across their group level and to cater with ease to their future customers. The unit has submitted the following revised projections of NFE details along with new product:- Fx Balance 1st Year 2nd Year 3rd Year 4th Year 5th Year Total Total $ in Sheet (Rs. In (Rs. In (Rs. In (Rs. In (Rs. In (Rs. In thousand lakh) lakh) lakh) lakh) lakh) lakh) Value of - - 4,647 24,728 36,908 66,283 93,834 Exports for the first 5 years Foreign Export - - 2,086 10,133 14,589 26,808 37,442 outgo for the first 5 years Net Foreign - - 2,561 14,595 22,319 39,475 56,392 Exchange earnings for the first 5 years Employment and Investment:-The unit has informed that there would be no changes what so ever in terms of Employment, Investment and Additional storage. They would trade in fabric, Sewing Trims and Packing Trims only. In terms of Rule 19(2), Approval Committee may also approve proposal for broad banding, diversification, enhancement of capacity of production, change in the terms of manufacture or service activity. Accordingly, the proposal is placed before UAC for consideration. Table Agenda Item No. 02 : Request of M/s. Aurobindo Pharma Limited, unit in APIIC, Multiproduct SEZ for inclusion of additional product under broad-banding in LOA. M/s. Aurobindo Pharma Limited vide letters dated 24.10.2018 has requested for inclusion of the following additional products in the LoA.. S.No Name of the Product UOM ITCHS Annual Capacity C o d e 2 100th UAC Meeting (21.12.2018) VISAKHAPATNAM 1 Losartan Potassium Tablets-25mg Mil 30049073 177 2 Losartan Potassium Tablets-50mg Mil 30049073 381 3 Silodosin Capsules – 4mg Mil 30049099 1.5 4 Silodosin Capsules – 8mg Mil 30049099 9 5 Dolutegravir,Lamivudine and Tenofovir Mil 30049099 802 50mg+300mg+300mg DisproxilFumarate Tablets 6 Fluoxetine Capsules-10mg Mil 30049099 155 7 Fluoxetine Capsules-20mg Mil 30049099 544 8 Fluoxetine Capsules-40mg Mil 30049099 243 9 Valaciclovir Hydrochloride Tablets-500mg Mil 30049099 144 10 Valaciclovir Hydrochloride Tablets-1gm Mil 30049099 125 11 Tramadol Hydrochloride Tablets-50mg Mil 30049099 484 12 Sertraline Hydrochloride Tablets-25mg Mil 30049099 136 13 Sertraline Hydrochloride Tablets-50mg Mil 30049099 452 14 Sertraline Hydrochloride Tablets-100mg Mil 30049099 635 15 Dofetilide Capsules-0.125mg Mil 30049099 1 16 Dofetilide Capsules-0.25mg Mil 30049099 2.5 17 Dofetilide Capsules-0.50mg Mil 30049099 2.64 18 EletriptanHydrobromide tablets-20mg Mil 30049099 0.37 19 EletriptanHydrobromide tablets-40mg Mil 30049099 2.49 20 Loperamide Hydrochloride and Mil 30049099 14 Simethicone Tablets-2mg/125mg The unit has submitted DRUG LICENSE for the above products. In terms of Rule 19(2), approval Committee may also approve proposal for broad banding, diversification, enhancement of capacity of production, change in the items of manufacture or service activity, if it meets the requirement of rules 18. Accordingly, the proposal is placed before UAC for consideration. Table Agenda Item No. 03: Request of M/s. Honour Lab Limited, unit in M/s Hetero Infrastructure Ltd, SEZ for inclusion of additional product under broad-banding in LOA- Reg. M/s. Honour Lab Limited vide letter dated 11.12.2018 has requested for inclusion of the following additional product in the LoA. S.No Name of the Product API ITC CODE NO. Annual Capacity 1 URSODIOL API 29372900 50 TONS 2 BETRIXABAN MALEATE API 29333990 50 TONS 3 POLMACOXIB API 29350090 50 TONS 4 REMOGLIFLOZIN ETABONATE API 29093090 50 TONS 3 100th UAC Meeting (21.12.2018) VISAKHAPATNAM 5 SAFINAMIDE MESYLATE API 29093090 50 TONS The unit has submitted drug license dt. 16.11.2018, 28.08.2018 & 30.08.2018 valid upto three years. In terms of Rule 19(2), approval Committee may also approve proposal for broad banding, diversification, enhancement of capacity of production, change in the items of manufacture or service activity, if it meets the requirement of rules 18. Accordingly, the proposal is placed before UAC for consideration. Table Agenda Item No. 04 : Request of M/s. GVK Biosciences Pvt. Ltd., unit in M/s Ramky Pharma City SEZ, Parawada, Visakhapatnam for inclusion of additional product under broad-banding in LOA. M/s. GVK Biosciences Pvt. Ltd.vide letters dated 18.12.2018 has requested for inclusion of the following additional products in the LoA.. S.No Name of the Product IT CHS Code 1 (1R,2S,3S,4R)-3-(2-(5-chloro-1H-pyrrolo[2,3-b]pyridin-3-yl)-5- 29420090 fluoro-7H-pyrrolo[2,3-d]pyrimidin-7-yl)bicyclo[2.2.2]octane-2- carboxylic acid (CDS-0100) 2 1-(3-(dimethylamino)-4-methylphenyl)-3-((5—(2,6-dioxopiperidin- 29420090 3-yl)-6-oxo-5,6-dihydro-4H-thieno[2,3-c]pyrrol-2- yl)methyl)urea(CDS-0124) 3 :8-bromo-6,7-difluoro-1,4,4,9-tetramethyl-4,5-dihydro- 29420090 [1,2,4]triazolo[4,3-a]quinoxaline (CDS-0135) 4 2-((1r, 4r)-4aminocyclohexyl)acetonitrile hydrochloride (CDS- 29332990 0042) 5 Ethyl,(R)-4((1-(-2-cyanoacetyl) pimperidin-3yl) amino)-1H- 29332990 pyrrolo[2,3-b] Pyridine-5-carboxylate (CDS-0088) 6 2-(6-aminopyridin-3-yl) propan-2-ol succinate (CDS-0025) 29420090 7 STG-03 (final stage of CDS0114-02): (3-chloro-7- 29420090 methoxyquinolin-4-yl)(4-fluorophenyl)methanone (CDS-0114) 8 Methyl (1s,4s)-4-(4-hydroxy-6-methylpyrimidin-2-yl)-1- 29420090 methoxycyclohexane-1-carboxylate (CDS-0099) 9 N-1 : 3-chloro-4-((3,5-difluropyridin-2yl)methoxy)-2’-(2-(2- 29420090 hydroxypropane-2-yl)pyrimidin-4-yl)-5’,6-dimethyl-2H-[1,4’- bipyridin]-2-one The unit has informed that the above products are intermediates and DRUG LICENSE are not required for the above product. Further the unit has informed that they are unable to specify the Manufacturing Quantity because these are intermediates every time they will get the new intermediates for manufacturing. 4 100th UAC Meeting (21.12.2018) VISAKHAPATNAM In terms of Rule 19(2), approval Committee may also approve proposal for broad banding, diversification, enhancement of capacity of production, change in the items of manufacture or service activity, if it meets the requirement of rules 18. Accordingly, the proposal is placed before UAC for consideration. Table Agenda Item No. 05 : Inclusion of QC/QA related services as part of the LoA for extending to all without restriction –request for broad banding of LoA to include services –By Dr. Reddy Laboratories Ltd, Formulations Tech Ops-IX- Reg. Dr. Reddy Laboratories Ltd, Formulations Tech Ops-IX , unit in VSEZ has submitted the proposal for Inclusion of QC/QA related services as part of the LoA for extending to all SEZ units and DTA units without restriction. The proposal of the unit was placed in the UAC meeting held on 29.9.2016 and the Unit approval committee after deliberation has approved the proposal for inclusion of additional activity i.e. Advanced instrumentation Lab(R&D) for rendering QC/QA related services under broad banding exclusively for Dr. Reddy‖ s Laboratories Limited (FTO-IX) a unit in VSEZ only and not for other SEZ and DTA units. Subsequently, Dr. Reddy‖ s Laboratories Limited (FTO-IX) has submitted the request and requested for grant of permission to extend the QC/QA related services to other units in SEZs and units in DTA.