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

Transcription

1 Editin: Versin th f June 2018 List Of RV Pharmaceutical Prducts classified accrding t the Fund Quality ssurance Plicy The list is an verview f pharmaceutical prducts subject t the Fund Quality ssurance Plicy that are listed in Natinal and/r standard treatment guidelines and classified accrding t the varius ptins (,, and ERP reviewed) defined in the Fund Quality ssurance Plicy (July 2009, amended in December 20). The list is develped as a tl t assist Principal Recipients (PR) f Fund grants t identify the status f finished pharmaceutical prducts accrding t the Fund Quality ssurance Plicy. The pharmaceutical prducts are classified based n the fllwing infrmatin classified prduct - Listed n prequalificatin list; classified prduct - Stringent NDR Registratin letter/marketing uthrizatin; ERP reviewed prduct- Permitted fr time-limited prcurement based n advice by the Expert Review Panel (ERP); Please nte that the list is nt an exhaustive list. PR can prcure prduct(s) nt listed in the current list as lng as PR demnstrates that the prduct is cmpliant with the Fund Quality ssurance Plicy. The Fund list includes the fllwing infrmatin: - "Imprtant Ntes" fr helpful infrmatin; -,, and ERP reviewed prducts; - Perid validity f the ERP reviewed prducts; - "+" means cmbinatin prduct, bth fixed-dse cmbinatin (c-frmulated) and c-packaged prduct ( i.e. c-blister) - [+]+C means and are in fixed-dse frmulatin and C is c-packaged YELLOW signifies a new entry; PINK signifies mdificatin f an existing entry. Fr mre infrmatin, please lk at: Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 1/56

2 Expert Review Panel (ERP): Expert Review Panel is an independent technical bdy cmpsed f external technical experts, hsted by Department f Essential Medicines and Pharmaceutical Plicies, t review the ptential risks/benefits assciated with the use f FPPs that are nt yet -prequalified r -authrized and t advise the Fund in its decisin n whether t allw grant funds t be used t prcure FPP. ERP reviewed prducts can be prcured fr a limited time (maximum 12 mnths). Hwever, under certain circumstances, it is pssible t extend the recmmendatin perid. Cntracts t supplier/manufacturer fr an ERP reviewed prducts shuld nt be lnger than the validity perid f the recmmendatin f that prduct. Fr detail infrmatin n ERP prcess and Quality ssurance infrmatin, please lk at Prcurement f ERP Reviewed Prducts: Principal Recipients (PRs) must infrm the cncerned Fund Prtfli Manager (FPM) at the Fund in writing by filling the Ntificatin Frm ( available n website) if they intend t prcure ERP-reviewed prduct(s). The Fund Secretariat will review the ntificatin request and upn issuing a n bjectin letter t the PR fr the requested selectin, prcurement can nly prceed. Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 2/56

3 Imprtant Ntes This List may be used by Principal Recipients f Fund grants when cnsidering ptins with respect t prcurement f pharmaceutical prducts pharmaceutical prducts subject t the Fund Quality ssurance Plicy. The list aims at prviding cuntries with infrmatin that will assist them in their prcurement ptins. Please nte that the list is nt designed t be a basis fr cuntries t select medicines t be included in their Natinal Treatment Guidelines r t replace any applicable and legally required prcurement prcesses. The Fund requires its grant recipients t cmply with applicable prcurement laws and prvides the list nly fr the identificatin f prducts/manufacturers that cmply with the Fund s quality assurance plicy. It is imprtant t nte that there is n strict requirement t prcure accrding t the list, as lng as the Principal Recipients can ensure that the prduct selected is cmpliant with the Quality ssurance plicy criteria. Furthermre, the Principal Recipient shuld nt rely slely n the infrmatin prvided in the list but shuld btain evidence f prducts cmpliance with the Quality ssurance plicy. Fr the abve reasns, we strngly encurage users t ensure they are using the mst recent versin n ur website when cnducting prcurement. The Lists will be updated regularly based n evidence received by the Fund. Interested parties are invited t supply infrmatin and evidence f prducts meeting the plicy criteria n an nging basis. Fr the abve reasns, we strngly encurage users t ensure they are using the mst recent versin n ur website when cnducting prcurement. ccrding t the plicy, if there are tw r mre r classified manufacturers available fr any given prduct ND the prduct is available frm these manufacturers (available-means that the manufacturer can supply the selected prduct within 90 days after receiving the Purchase Order), then such prduct must be prcured frm r classified prduct manufacturers. The PR must ntify by writing t the Fund Secretariat (Fund Prtfli Manager) and recieve the "N Objectin" letter frm GF secretariat befre prcuring any prducts cmplying with ptin " ERP Reviewed". Fr ease f reference, each "prduct" has been identified in this list with a unique "Prduct reference number" (Clumn ). Please see examples belw. Several different dsage frms may be gruped under the same Prduct Reference Number and therefre will be cnsidered the same type f prducts when identifying the number f available manufacturers fr the applicatin f this plicy. These prducts share the same dsing prtcl, target the same ppulatin, and there are n fundamental differences amng them. Fr example, within slid frms, sme capsules will have same reference number as tablets while within liquids, ral slutin and suspensin are gruped tgether.similarly, the enter cated tablet r dispersible tablet will nt share the same reference number as nn enter cated r dispersible tablets. Prduc t Ref.N Internatinal Nn-prprietary Strength Manufacturer * Fund Q ed/ Manufacturing site* Cuntry Material Pack XYZ 50mg "Pharma Cmpany 16 " 0mg "Pharma Cmpany 17 " - "Pharmaville" Cuntry bttle 60 - "Pharmaville" Cuntry bttle 60 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 3/56

4 The example abve shws 2 different variants f the same medicine. ecause the strength is different, it is cnsidered 2 different prducts (there are tw different reference numbers 16 and 17). If the strength had been the same but the dsage frm had been different (i.e. tablet and liquid) it wuld als have been cnsidered tw different "prducts". Prduc t Ref.N Internatinal Nn-prprietary Strength Manufacturer * Fund Q ed/ Manufacturing site* Cuntry Packaging 25 C 150mg "Pharma Cmpany - "Pharmaville" Cuntry,, 60 " bttle Capsules "Pharma Cmpany " - "Pharmaville" Cuntry ttle, 60, In this secnd example bth prducts have same reference number (25) because bth manufacturers are supplying the same strength and the dsage frms are cnsidered similar as per explanatin abve. * See belw Disclaimer: The Fund des nt endrse r warrant the fitness f any prduct n the List fr a particular purpse, including in regard f its safety and/r efficacy in the treatment f HIV/IDS, HCV,tuberculsis r malaria. In additin, the Fund assumes n respnsibility fr any misstatement r missin frm the list and directs Principal Recipients f Fund grants t cnduct their wn independent cnfirmatin that the infrmatin n a given prduct n the list is accurate befre relying n it t make a purchase rder fr that prduct, and t ensure that any purchase is in cmpliance with all the requirements f the Fund s quality assurance plicy. The Fund des nt warrant r represent that the prducts listed have btained regulatry apprval fr use f treatment f any disease in any particular cuntry f the wrld, r that their use is therwise in accrdance with the natinal laws and regulatins f any cuntry, including, but nt limited t, intellectual prperty laws. The Fund disclaims any and all liability and respnsibility fr any injury, death, damage r lss f any kind whatsever that may arise as a result f, r in cnnectin with the prcurement, distributin and use f any prduct included in the list. * s frm versin 137, please nte that we cnsider under Supplier / Manufacturer : Marketing authrizatin/ prduct authrizatin r license hlder Manufacturing Site: The Site respnsible fr the release f the FPP Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 4/56

5 List f r prducts: If there are tw r mre r prducts available, then the prduct must be prcured frm ne f the r prducts. Nte: if the prduct intended fr selectin is nt listed in this list, please refer t the List f ERP ( Expert Review Panel) Reviewed Prducts which are permitted fr time limited prcurement: Ref.N 1 bacavir (C) 20 mg / ml Oral slutin ViiV HealthCare Mississauga, Ontari Canada bttle 240ml bacavir (C) as sulfate 20 mg / ml Oral Slutin Meditabs Specialities Pvt Satara, Maharastra PET ttle 0ml bacavir (C) as sulfate 20 mg / ml Oral Slutin Heter labs limited Unit III 22-1 Industrial develpment rea Jeedimetla, Hyderabad ndhra Pradesh, ttle 240ml bacavir (C) 20 mg / ml Oral Slutin urbind Pharma Unit III, Survey N. 313 &314 achupally, Mandal Hyderabad, ndhra Pradesh ttle 240ml 2 bacavir (C) as sulfate 60 mg Dispersible Cipla , MIDC Patalganga ttle 60 bacavir (C) as sulfate 60 mg - Sinnar, Nashik, 60 bacavir (C) as sulfate 60 mg Dispersible Micrlabs H674 Micr Labs, Phase III & Phase IV, Plt N. S-155 t S-159 & N1 Verna Industrial Estate, Verna, Ga 60 3 bacavir (C) 300 mg Cipla , MIDC Patalganga ttle, 60 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 5/56

6 bacavir (C) 300 mg ViiV HealthCare - bacavir (C) 300 mg bacavir (C) 300 mg Sun Pharmaceutical Industries - Glax Operatins UK,, Ware, Herthfrdshire, UK; GSK, Pznan (packaging and release), Pland Panta Sahib, Himachal Pradesh UK 60 ttle; ttle; 60; 6* 60; 6* bacavir (C) as sulfate 300 mg Film cated Strides rclab - 36/7, Suragajakkanahalli Indlavadi crss nekal Taluk angalre ttle; 60; 6* bacavir (C) 300 mg Heter labs limited - Unit III 22-1, Industrial develpment rea, Jeedimetla, Hyderabad ndhra Pradesh, ttle; Film Package 60, 0, 500; bacavir (C) 300 mg urbind Pharma Unit III, Survey N 313 achyupally, Mandal Hyderabad, ndhra Pradesh Unit-VII (SEZ), Mahabb Nagar (DT), ndhra Pradesh ttle; 60 ; 4 bacavir + Lamivudine 60 mg + 30 mg urbind Pharma Unit III, Survey N. 313 and 314, achupally Mandal Hyderabad, ndhra Pradesh ttle; 30, 60; * Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 6/56

7 5 6 bacavir (as Sulfate)+ Lamivudine 60 mg + 30 mg bacavir+lamivudine 60 mg + 30 mg Heter labs limited bacavir Sulfate + Lamivudine bacavir Sulfate + Lamivudine bacavir and Lamivudine s fr Oral Suspensin 60 mg + 30 mg 60 mg + 30 mg 120 mg / 60 mg s fr ral suspensin s fr ral suspensin s fr Oral Suspensin - ND Cipla. - Heter Labs Unit V SEZ Unit I in PIIC SEZ Plepally Village, -33, MIDC Patalganga Waluj, urangabad,, bttle 30, 60 bttle 30 lu-lu blisters cntainer; X 60, 120; bttle 60 bttle 30, 2000 bacavir (as Sulfate) + Lamivudine 120 mg / 60 mg Disp. Cipla. - H662 ND Plt N 33, 2 (Unit I), MIDC, Patalganga District Raigad,, ttle 60 7 bacavir + Lamivudine 600 mg mg urbind Pharma Unit - III Survey N. 313 & 314, achupally, Mandal Hyderabad, ndhra Pradesh ttle; 30; bacavir + Lamivudine bacavir Sulfate+ Lamivudine bacavir + Lamivudine 600 mg mg 600 mg mg 600 mg mg Film cated Glax SmithKline. Cipla. - Ware,Hertfrdshire; randa de Duer, urgs; Research Triangle Park, NC -33, MIDC Patalganga, UK, Spain, US ttle ttle; ; 3* ttle 28; 30 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 7/56

8 8 9 bacavir + Lamivudine bacavir (as Sulfate)+ Lamivudine + Zidvudine bacavir + Lamivudine + Zidvudine bacavir + Lamivudine + Zidvudine bacavir (as Sulfate)+ Lamivudine + Zidvudine 600 mg mg 60 mg + 30 mg + 60 mg 300 mg mg mg 300 mg mg mg 300 mg mg mg Heter labs limited - H657 Sun Pharmaceutical Industries ViiV HealthCare - - Heter Labs, Unit-V SEZ Unit I Survey N. 439, 440, 441 & 458 Mahabb Nagar. Panta Sahib, Himachal Pradesh Glax Operatins UK,, Ware, Hertfrdshire, UK; GSK, Pznan (packaging and release), Pland ttle 30 's x 60 bttle 60 UK tte, 60; 40; 60 ttle 60 bacavir + [Lamivudine + Zidvudine] 300 mg mg mg urbind Pharma Unit III, Survey 313 & 314, achupally, Mandal, Hyderbad, ndhra Pradesh, PVC / PVdC / luminum Fil Card Cntains: + Each Cartn Cntains: ciclvir 200 mg H625, Plt N H-12 & H13 MIDC Waluj Industrial rea, urangabad,, , PVC/lu blister PVC/PVdC/ lu blister x1 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 8/56

9 ciclvir 400 mg Heter labs limited H554 ciclvir 400 mg 11 tazanavir 50 mg / 1.5g Oral pwder 12 tazanavir 0 mg Hard Capsule tazanavir 0 mg Capsule ristl-myers Squibb ristl-myers Squibb Emcure H626 Unit 5, Survey N 439, 440, 441 & 458 TSIIC Frmulatin SEZ, Plepally Village, Jadcherla (M), Mahabb Nagar District, Telangana, , Plt N H-12 & H13 MIDC Waluj Industrial rea, urangabad,, , Hunslw UK Hunslw UK Hinjwadi, Pune Cntainer PVC/lu blister PVC/PVdC/ lu blister ttle () ttle () (alu) bttle; 500x1, 0x1 x1 180g 60, 60 60; tazanavir 0 mg Capsule urbind Pharma Unit-VII (SEZ), Mahabb Nagar (DT), ndhra Pradesh bttle 60, tazanavir 150 mg Capsule tazanavir 150 mg Capsule Hard tazanavir 150 mg Capsule ristl-myers Squibb ristl-myers Squibb Emcure Evansville, nna, Munt Vernn, nna (primary packaging) Hunslw UK US bttle 60 ttle () (alu) Hinjwadi, Pune bttle Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 9/56

10 tazanavir 150 mg Capsule spen Pharmacare ND Elizabeth (Pty), Crner Fairclugh and Gibaud Rads, Krsten, Prt Elizabeth, 6020 Suth frica bttle 60 tazanavir ( as Sulfate) 150 mg Capsule - Sinnar, Nashik District,, ; Waluj, urangabad,, ttle 30, 0 tazanavir ( as Sulfate) 150 mg Capsule urbind Pharma Unit-VII (SEZ), Mahabb Nagar (DT), ndhra Pradesh bttle 60,180, tazanavir 200 mg Capsule Hard tazanavir 200 mg Capsule ristl-myers Squibb Emcure Hunslw UK Hinjwadi, Pune ttle () (alu) bttle; 60, 60 60; tazanavir 200 mg Capsule urbind Pharma Unit-VII (SEZ), Mahabb Nagar (DT), ndhra Pradesh bttle 60,180, 500 tazanavir 200 mg Capsule 15 tazanavir ( as Sulfate) 300 mg Capsule tazanavir ( as Sulfate) 300 mg Capsule spen Pharmacare ristl-myers Squibb Emcure ND Elizabeth (Pty), Crner Fairclugh and Gibaud Rads, Krsten, Prt Elizabeth, 6020 Suth frica bttle 60 Evansville, na, US ttle 30 Hinjwadi, Pune ttle 30 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy /56

11 tazanavir ( as Sulfate) 300 mg Capsule - Sinnar, Nashik District,, ; Waluj, urangabad,, ttle 30, 0 tazanavir ( as Sulfate) 300 mg Capsule urbind Pharma Unit-VII (SEZ), Mahabb Nagar (DT), ndhra Pradesh bttle 30, 90, tazanavir (sulfate)+ Ritnavir tazanavir (sulfate)+ritnavir tazanavir (sulfate)/ritnavir 300mg + 0mg 300mg+0mg (FDC) Emcure - 300mg+0mg Cipla. H632 ttle 30, 90, 120 Hinjwadi, Pune ttle 30 Cipla, Unit 2, Plt - 42 MIDC Industrial rea, Patalganga, Raigad District, ttle lu/lu 30x1; x3 17 [tazanavir Sulfate+ Ritnavir] +[Lamivudine and Zidvudine] [300 mg / 0 mg] +[150 mg / 300 mg] c-packaged s Sinnar, Nashik District , PVC blister Cartns cntaining 5 blister packs (cnsisting f PVC/clar film and cated aluminum fil), each cntaining tw 1-day cards, fr a day supply. Three cartns are further packaged tgether fr a 30 day supply Darunavir 75mg s F-4, F-12, Malegan M.I.D.C, Sinnar, Nashik , state,. ttle 0; 500; 480 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 11/56

12 20 Darunavir (as Ethanlate) Darunavir (as Ethanlate) Darunavir (as Ethanlate) 75 mg s Janssen Infectius Diseases - Diagnstics V/ Pharmacare Suth frica - 75 mg s Lupin 150 mg s Cipla ND Janssen Orth LLC, Gurab, Puert Ric, United States (Manufacturing and release testing); Janssen-Cilag Sp, Latina, Italy (Testing and final QC release and packaging) Puert Ric ttle 480 Plt N. 15, Phase 1, Verna Industrial rea, Verna, Salcette Ga ttle 480 (Unit II), MIDC, Patalganga ttle 480 Darunavir 150mg s F-4, F-12, Malegan M.I.D.C, Sinnar, Nashik , state,. ttle 240; Darunavir (as Ethanlate) 150 mg s Janssen Infectius Diseases - Diagnstics V/ Pharmacare Suth frica - Janssen Orth LLC, Gurab, Puert Ric, United States (Manufacturing and release testing); Janssen-Cilag Sp, Latina, Italy (Testing and final QC release and packaging) Puert Ric ttle 240 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 12/56

13 Darunavir (as Ethanlate) 150 mg s Lupin Plt N. 15, Phase 1, Verna Industrial rea, Verna, Salcette Ga ttle 240 Darunavir 300mg s Darunavir (as Ethanlate) 22 Darunavir 400mg s 300 mg s Lupin F-4, F-12, Malegan M.I.D.C, Sinnar, Nashik , state,. Plt N. 15, Phase 1, Verna Industrial rea, Verna, Salcette Ga F-4, F-12, Malegan M.I.D.C, Sinnar, Nashik , state,. ttle 120; 360 ttle 120 ttle 60; 180; 360 Darunavir 400 mg s Janssen Infectius Diseases - Diagnstics V/ Pharmacare Suth frica Jansen Orth LLc, Gurab Puert Ric ttle 60 Darunavir 400mg Heter Labs limited Darunavir Ethanlate 400mg Cipla - UNIT-III, Hyderabad ttle 60 H627 ND (Unit II), MIDC, Patalganga ttle 60 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 13/56

14 Darunavir (as Ethanlate) 23 Darunavir 600mg s 400mg Lupin Plt N. 15, Phase 1, Verna Industrial rea, Verna, Salcette Ga F-4, F-12, Malegan M.I.D.C, Sinnar, Nashik , state,. ttle 60 ttle 60; 180; 360 Darunavir 600 mg s Darunavir 600 mg s Darunavir 600mg Janssen Infectius Diseases - Diagnstics V/ Pharmacare Suth frica Janssen Infectius Diseases - Diagnstics V/ Pharmacare Suth frica Heter Labs limited Jansen Orth LLc, Gurab Puert Ric ttle 60 Janssen Orth LLC, Gurab, Puert Ric, US (manufacturing and release testing); Janssen-Cilag Sp, Latina, Italy (packaging, testing and QC release); US ttle 60 UNIT-III, Hyderabad ttle 60 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 14/56

15 Darunavir 600 mg Film cated Sandz, UK Manufacturer LEK farmacevtska družba d.d. Vervškva 57, 1526 Ljubljana, Slvenia r Salutas Pharma GmbH, Ott-vn- Guericke-llee 1, Sachsen-nhalt, arleben, Germany r Remedica, harnn Street, Limassl Industrial Slvenia Germany Cyprus luminium- PVC/PE/PV DC perfrated blisters bttles 60x1 unit dse blister, 30, 60, 90, , 120 (2x60), 180 (3x60), 240 (4x60) Darunavir Ethanlate 600mg Cipla - H628 ND (Unit II), MIDC, Patalganga ttle 60 Darunavir (as Ethanlate) Darunavir (as Ethanlate) 24 Didansine (ddi) 2 g 600mg Lupin 800mg Lupin Pwder fr Oral Slutin ristl-myers Squibb Plt N. 15, Phase 1, Verna Industrial rea, Verna, Salcette Ga Plt N. 15, Phase 1, Verna Industrial rea, Verna, Salcette Ga Munt Vernn, na, US; nagni (Secndary packaging and batch release), Italy ttle 60 ttle 30 & 90 US Glass ttle 2g Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 15/56

16 25 Didansine (ddi) mg / ml Pwder fr Oral Slutin 26 Didansine (ddi) 25 mg 27 Didansine (ddi) 50 mg 28 Didansine (ddi) 0 mg 29 Didansine (ddi) 125 mg Capsule Delayed release ristl-myers Squibb ristl-myers Squibb ristl-myers Squibb ristl-myers Squibb Meymac Evansville, na, France US bttle Emcure, New jersy US bttle 60 Emcure, New jersy US bttle 60 Emcure, New jersy US bttle 60 HDPPE ttle 2g 30, 500 Didansine (ddi) 125 mg Capsule Delayed release urbind Pharma Unit - III Survey N. 313 & 314, achupally, Mandal Hyderabad, ndhra Pradesh bttle 30, 500; Didansine (ddi) 150 mg 31 Didansine (ddi) 200 mg Didansine (ddi) 200 mg Capsule Delayed release Capsule Delayed release ristl-myers Squibb arr Labratries, Inc. Emcure, New jersy US bttle 60 bttle 30, 500 Pmna, NY US ttle 30 Didansine (ddi) 200 mg Capsule Delayed release urbind Pharma Unit - III Survey N. 313 & 314, achupally, Mandal Hyderabad, ndhra Pradesh ttle 30, 500; 32 Didansine (ddi) 250 mg Capsule Delayed release ttle 30, 500 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 16/56

17 Didansine (ddi) 250 mg Capsule Didansine (ddi) 250 mg Capsule Delayed release ristl-myers Squibb arr Labratries, Inc. Munt Vernn, na, US; nagni (Primary and secndary packaging and batch release), Italy US 30 Pmna, NY US ttle 30 Didansine (ddi) 250 mg Capsule Delayed release urbind Pharma Unit - III Survey N. 313 & 314, achupally, Mandal Hyderabad, ndhra Pradesh bttle; 30, Didansine (ddi) 400 mg Capsule Delayed release Didansine (ddi) 400 mg Capsule ristl-myers Squibb Munt Vernn, na, US; nagni (Primary and secndary packaging and batch release), Italy ttle 30, 500 US 30 Didansine (ddi) 400 mg Capsule Delayed release arr Labratries, Inc. Pmna, NY US ttle 30 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 17/56

18 Didansine (ddi) 400 mg Capsule Delayed release urbind Pharma Unit - III Survey N. 313 & 314, achupally, Mandal Hyderabad, ndhra Pradesh bttle; 30, 500; 5 34 Dlutegravir (as sdium salt) 50mg s ViiV Healthcare Glax Operatins UK, Hertfrdshire (manufacturing and quality cntrl), UK; Glax Wellcme S.., urgs (primary and secndary packaging, batch release), Spain UK ttle 30 Dlutegravir (as sdium salt) 50mg s Cipla. H680 Cipla, Unit IV, Plt N 9, & 15 Indre Special Ecnmic Zne, Phase II, Pithampur, Dhar District, Madhya Pradesh, , ttle, 30x1;90x1 Dlutegravir (as sdium salt) 50mg s urbind Pharma ND urbind Pharma, Unit VII, SEZ, TSIIC, Plt N. S1, Survey N. s 411, 425, 434, 435 & 458, Green Industrial Park, Plepally village, Jedcherla Mandal, Mahabb Nagar District, Telangana State bttle 30 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 18/56

19 Dlutegravir + Lamivudine + Tenfvir disprxil fumarate + Dlutegravir + Lamivudine + Tenfvir disprxil fumarate + 50mg mg mg 50mg mg mg 35 Efavirenz (EFV) 30 mg / ml Oral Slutin urbind Pharma Mylan labratries Merck Sharp & Dhme - ND ND Unit VII,SEZ, TSIIC, Plt N. SI, Survey N. 411/P, 425/P,434/P, 435/P,458/P Green industrial Park, Plepally Village, Jedcherla Mandal, Mahabb Nagar Telangana (FDF-3) Plt N. 11, 12 & 13, Indre Special Ecnmic Zne Pharma Zne, Phase II, Sectr III, Pithampur District Dhar Madhya Pradesh Pathen Inc. Mississauga, Ontari Harlem Manati, Harlem Cntainer 30 ttle 30, 90, 180 Canada Netherlands ttle 180ml Merck Sharp & Puert Ric 36 Efavirenz (EFV) 50 mg Capsule bttle 30 Dhme Netherlands Efavirenz (EFV) 50 mg Capsule Micrlabs Verna, Ga ttle 30, 60, 90 Efavirenz (EFV) 50 mg Capsule urbind Pharma Unit III, Survey N. 313 &314 achupally, Mandal Hyderabad, ndhra Pradesh Unit-VII (SEZ), Mahabb Nagar (DT), ndhra Pradesh bttle; 30 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 19/56

20 37 Efavirenz (EFV) 50 mg Efavirenz (EFV) 50 mg 38 Efavirenz (EFV) 0mg Efavirenz (EFV) 0mg 39 Efavirenz (EFV) 0mg Dispersible Merck Sharp & Dhme urbind Pharma Sun Pharmaceutical Industries 40 Efavirenz (EFV) 200 mg Capsule Cipla. - Efavirenz (EFV) 200 mg Capsule Efavirenz (EFV) 200 mg Capsule Merck Sharp & Dhme Sun Pharmaceutical Industries Suth Granville, N Haarlem (packager, respnsible fr batch release in the EU) Unit III, Survey N. 313 &314 achupally, Mandal Hyderabad, ndhra Pradesh ustralia bttle 30 ttle 30, 90 ttle 30, 90 ttle; 30, 500; Mhali, Punjab ttle 30 Plt N. L-147, L147-1, Verna Ga, Manati, Harlem Panta Sahib, Himachal Pradesh ttle 90, 00 Puert Ric Netherlands bttle 90 bttle; 90; 90 Efavirenz (EFV) 200 mg Capsule urbind Pharma Unit III, Survey N. 313 &314 achupally, Mandal Hyderabad, ndhra Pradesh Unit-VII (SEZ), Mahabb Nagar (DT), ndhra Pradesh bttle; 30, 90; Efavirenz (EFV) 200 mg Capsule Micrlabs Verna, Ga ttle 30,60,90 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 20/56

21 41 Efavirenz (EFV) 200 mg Film cated Strides rclab - 36/7, Suragajakkanahalli Indlavadi crss nekal Taluk angalre bttle 90 Efavirenz (EFV) 200 mg Efavirenz (EFV) 200 mg Merck Sharp & Dhme Suth Granville, N Haarlem (packager, respnsible fr batch release in the EU) ustralia bttle 90 ttle 30, Efavirenz (EFV) 600 mg Merck Sharp & Dhme ristl-myers Squibb Pharma, Manati, Puert Ric; Merck Sharp & Dhme ustralia Pty., Suth Granville, ustralia; Merck Sharp & Dhme, V Haarlem, The Netherlands; Zhejiang Huahai Pharmaceutical C.,, Zhejiang, China Puert Ric ustralia Netherlands China bttle 30 Efavirenz (EFV) 600 mg Sun Pharmaceutical Industries Panta Sahib, Himachal Pradesh bttle ; 30; 30 Efavirenz (EFV) 600 mg Film cated urbind Pharma Unit III Survey N. 313, achupally, Mandal, Hyderabad, ndhra Pradesh Unit-VII (SEZ), Mahabb Nagar (DT), ndhra Pradesh ttle; 30, Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 21/56

22 Efavirenz (EFV) 600 mg Efavirenz (EFV) 600 mg Shanghai Desan i-pharmaceutical C. - H658 Efavirenz (EFV) 600 mg Cipla Zhangheng Rad, Zhangjiang Hi-Tech Park, Shanghai L-139 t L-146, Verna Ga Quality Chemical Industries, Kampala bttle; 28, 30; China bttle 30x1 Uganda bttle 30, 500 Efavirenz (EFV) 600 mg Film cated Strides rclab - 36/7, Suragajakkanahalli Indlavadi crss nekal Taluk angalre bttle 30 Efavirenz (EFV) 600 mg Film cated Heter labs limited - Unit-III, Jeedimetla, Hyderabad, ndhra Pradesh, ; Unit-V, Mahabb Nagar, ndhra Pradesh, Cntainer 28, 30, 250 Efavirenz (EFV) 600 mg Macleds - Himachal Pradesh cntainer 30 Efavirenz (EFV) 600 mg Emcure Hinjwadi, Pune bttle; 30, 60; 3* Efavirenz (EFV) 600 mg Micrlabs - H633 Verna, Ga bttle; 30x1 x3 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 22/56

23 Efavirenz (EFV) 600 mg Pharmacare.(trading as spen Pharmacare) H649 spen Prt Elizabeth, (Pty), Krsten Prt Elizabeth, Suth frica Suth frica Layflat laminat ag(pet/lu/ LLDPE) ttle Efavirenz (EFV) 600 mg Edict Private Chennai cntainer 30 Efavirenz (EFV) 600 mg Film cated Sandz, UK Lek d.d., Ljubljana r Salutas Pharma GmbH, arleben, r LEK S.., 672 Warszawa r Salutas Pharma GmbH, Dieselstr. 5, Gerlingen, Germany r S.C. Sandz, Targu-Mures, Slvenia Germany Pland Rmania White paque PVC/clar/ l blisters bttles, 28, 30, 50, 60, 84, 90, 0 r , 90 (3x30) r 120 (4x30) 43 Efavirenz + [Lamivudine + Zidvudine] 600 mg + [150 mg mg] urbind Pharma Unit - III Survey N. 313 & 314, achupally, Mandal Hyderabad, ndhra Pradesh PVC/PE/cl ar-l fil ; Cartn 6 blisters per bx Each blister has 5 x (2+1) Efavirenz + [Lamivudine + Zidvudine] 600 mg + [150 mg mg] Strides rclab 36/7, Suragajakkanahalli Indlavadi crss nekal Taluk angalre bttle 30 + (60) Efavirenz + [Lamivudine + Zidvudine] 600 mg + [150 mg mg] C packed Sinnar, Nashik District , cards. -day supply (5 twday blister cards cnsisting f PVC/PvDC film and cated aluminum fil) Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 23/56

24 44 Efavirenz + Emtricitabine + Tenfvir 600 mg mg mg Merck Sharp & Dhme Pathen Inc. Mississauga, Ontari MSD V Haarlem ( packaging and batch release site) Canada bttle 30 Efavirenz + Emtricitabine + Tenfvir Disprxil Fumarate 600 mg mg mg -, Waluj, urangabad, ; Mylan Pithambur, Dhar Dist., Madhya Pradesh bttle 28, 30, 0 Efavirenz + Emtricitabine + Tenfvir 600 mg mg mg Cipla. Plt N. L-147, L147-1, Verna Ga, ttle 30 Efavirenz + Emtricitabine + Tenfvir 600 mg mg mg urbind Pharma Unit-VII (SEZ), Mahabb Nagar (DT), ndhra Pradesh ttle 30, 0 Efavirenz + Emtricitabine + Tenfvir Efavirenz + Emtricitabine + Tenfvir Efavirenz + Emtricitabine + Tenfvir 600 mg mg mg 600 mg mg mg 600 mg mg mg Heter labs limited - Sun Pharmaceutical Industries Macleds Heter Labs, Unit-V SEZ Unit I Survey N. 439, 440, 441 & 458 Mahabb Nagar. Shasun, Periyakalapet, Pndicherry, ttle 28's, 30's and 500's, ttle 30 - Kachigam, Damam ttle 30 Efavirenz + Emtricitabine + Tenfvir 600 mg mg mg Strides rclab nekal Taluk, angalre, ttle 30 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 24/56

25 Efavirenz + Emtricitabine + Tenfvir Disprxil 600 mg+200 mg+300 mg ristl-myers Squibb and Gilead Sciences Carrigthill, Cunty Crk Ireland ttle 30 Efavirenz + Emtricitabine + Tenfvir Disprxil 600 mg+200 mg+300 mg Gilead Sciences, Inc. Pathen Inc. Mississauga, Ontari Canada ttle Efavirenz+ Lamivudine + Tenfvir Disprxil Fumarate 600 mg mg mg - ; H-12 & H-13, M.I.D.C, Waluj, urangabad Maharastra; Mylan Pithambur, Dhar Dist., Madhya Pradesh ttle 30, 0 Efavirenz+ Lamivudine + Tenfvir Disprxil Fumarate Efavirenz+ Lamivudine + Tenfvir Disprxil Fumarate Efavirenz+ Lamivudine + Tenfvir Disprxil Fumarate 600 mg mg mg 600 mg mg mg 600 mg mg mg urbind Pharma urbind Pharma Unit-VII (SEZ) Mahabb Nagar (Dt) P; ttle 30, 0 & 500 Cipla. - UNIT-II-Patalganga ttle 30 Macleds - Macleds addi, District Slan, Himachal Pradesh ttle 30 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 25/56

26 Efavirenz+ Lamivudine + Tenfvir Disprxil Fumarate 600 mg mg mg Heter labs limited - H549 ND Unit III, Survey N 51, Plt N 22-1 ID, Jeedimetla, Hyderabad, Telangana (Unit-V) S.N. 439,440, 441, & 458, TSIIC Frmulatin SEZ, Plepally Village, Jadcherla (Mandal), Mahabbnagar- (District). Pin Telangana Cntainer 30, 90, 0 Efavirenz+ Lamivudine + Tenfvir Disprxil Fumarate 400 mg mg mg (FDF-3) Plt N. 11, 12 & 13, Indre Special Ecnmic Zne, Pharma Zne, Phase - II, Sectr -III, Pithampur, District Dhar , Madhya Pradesh ttle Emtricitabine mg/ml ral slutin Gilead Sciences, Inc. Cuntry Crk Ireland ttle 170ml 47 Emtricitabine 200 mg Capsule Cipla. - Plt N. L-147, L147-1, Verna Ga, ttle 30, 00 Emtricitabine 200 mg Capsule urbind Pharma Unit - III Survey N. 313 & 314, achupally, Mandal Hyderabad, ndhra Pradesh ttle, 30, 500 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 26/56

27 Emtricitabine 200 mg Capsule Emtricitabine 200 mg Capsule 48 (Emtricitabine + Nevirapine) +Tenfvir 49 Emtricitabine +Tenfvir Disprxil Fumarate Emtricitabine + Tenfvir ( ) mg mg 200 mg mg s cpacked Film cated Gilead Sciences, Inc. Gilead Sciences, Inc. Gilead Sciences, Inc. - Fster City US Granta Park bingtn, Cambridge ltana Pharma, Oranienburg GmbH, Pathen Inc. Mississauga, Ontari spen Pharmacare, Prt Elizabeth, UK Germany Canada Suth frica ttle; ttle, lu/lu blister ttle () 30, 0; 2*, 3* 30 (1+2) per blister, 3 blisters in a cartn 30, 90(3x30) tablets bttle 30 Emtricitabine + Tenfvir disprxil fumarate 200 mg mg urbind Pharma Unit - III Survey N. 313 & 314, achupally, Mandal Hyderabad, ndhra Pradesh Unit-VII (SEZ), Mahabb Nagar (DT), ndhra Pradesh bttle 30 Emtricitabine + Tenfvir Disprxil Fumarate 200 mg mg - bttle; blister 28, 30,0; Emtricitabine + Tenfvir Disprxil Fumarate 200 mg mg Cipla. - Plt N. L-147, L147-1, Verna Ga, ttle 30 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 27/56

28 Emtricitabine + Tenfvir Disprxil Fumarate 200 mg mg Heter labs limited - Unit III 22-1, Industrial develpment rea, Jeedimetla, Hyderabad bttle 28, 30, 56 & 60 Emtricitabine + Tenfvir Disprxil Fumarate 200 mg mg Strides rclab - 36/7, Suragajakkanahalli Indlavadi crss nekal Taluk angalre bttle 30 Emtricitabine + Tenfvir Disprxil Fumarate Emtricitabine + Tenfvir Disprxil Fumarate 200 mg mg 200 mg mg Macleds Pharmacare H601 Kachigam, Daman, spen Prt Elizabeth, (Pty), Krsten Prt Elizabeth, Suth frica bttlelu/l u blister 30; x Suth frica bttle 30 Emtricitabine + Tenfvir Disprxil Fumarate 200 mg mg Sun Pharmaceutical Industries Shasun, Periyakalapet, Puducherry, bttle 30 Emtricitabine + Tenfvir Disprxil Fumarate 200 mg mg Micrlabs H631 Micr Labs, Phase III and Phase IV, Plt N S-155 t S-159 Verna Industrial Estate, Verna, Ga, , lu/lu ttle x1 30x1, 0x1 50 [Emtricitabine + Tenfvir Disprxil Fumarate]+Nevirapine 200 mg /300 mg c-packaged with 200 mg C packed Sinnar, Nashik District , cards. Cartns cntaining 5 blister packs (cnsisting f aluminum-aluminum blisters), each cntaining tw 1-day cards, fr a day supply. Three cartns are further packaged tgether fr a 30 day supply Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 28/56

29 [Emtricitabine + Tenfvir Disprxil Fumarate]+Nevirapine 200 mg /300 mg c-packaged with 200 mg C packed 51 Enfuvirtide 90mg/ml Injectin 52 Etravirine 25mg 53 Etravirine 0mg 54 Etravirine 200mg 55 Fsamprenavir (FPV) 700 mg 56 Indinavir (IDV) 200 mg Capsule Hard 57 Indinavir (IDV) 400 mg Capsule Indinavir (IDV) 400 mg Capsule Indinavir (IDV) 400 mg 58 Lamivudine (3TC) mg / ml Lamivudine (3TC) mg / ml Capsule Hard Oral Slutin Oral Slutin Macleds Hffmann-La Rche Inc. Janssen-Cilag Internatinal NV, elgium Janssen Infectius Diseases - Diagnstics V/ Pharmacare Suth frica Janssen-Cilag Internatinal NV, elgium Glax SmithKline. Merck Sharp & Dhme Heter Labs Merck Sharp & Dhme Merck Sharp & Dhme Kachigam, Daman, lu/lu blister asle Switzerland Vials Janssen-Cilag Sp, Latina, Italy rg San Michele, Latina Janssen-Cilag Sp, Latina, Italy (Manufacturing, packaging, release testing and final QC release) Janssen-Cilag Sp, Latina, Italy Glax Wellcme Operatins Hertfrd Rad, Hertfrdshire Unit-III, Jeedimetla, Hyderabad, ndhra Pradesh, (1 + 2) cmbipack vials f water fr inj+syringe Italy ttle 120 Italy ttle 120 Italy ttle 60 UK bttle 60 UK ttle l/l strip; bttle 180,270, 360 ; 180 Elktn, Virgina US bttle 180 Hertfrd Rad, Hertfrdshire UK ttle () 18, 90, 180 ViiV HealthCare Mississauga, Ontari Canada bttle 240ml Cipla. - Cipla L-139 t L-146, Verna Ga, Indre, SEZ, Pithampur, Dist Dhar (M.P.) PET bttle; bttle 0ml; 240ml Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 29/56

30 Lamivudine (3TC) Lamivudine (3TC) Lamivudine (3TC) mg / ml mg / ml mg / ml Oral Slutin Oral Slutin Oral Slutin Heter labs limited urbind Pharma Macleds Unit-III 22-1, Industrial Develpment rea Jeedimetla, Hyderabad ttle 240ml Hyderabad, Telangana ttle 240ml Slan, Himachal Pradesh, ttle 240ml 59 Lamivudine (3TC) 30mg Cipla. Ga ttle 60 Lamivudine (3TC) 30mg Micrlabs Verna, Ga PVC/PVdC/ lu blister ; bttle 60,0,500, Lamivudine (3TC) 30mg Disp 61 Lamivudine (3TC) 0 mg 62 Lamivudine (3TC) 150 mg Film cated Film Cated Sun Pharmaceutical Industries Glax SmithKline. Macleds Panta Sahib, Himachal Pradesh Ware, Hartfrdshire UK - Kachigam, Daman addi, H.P. ttle 60 ; ttle ttle; 28, 84 60; 6* Lamivudine (3TC) 150 mg Film cated Strides rclab - 36/7, Suragajakkanahalli Indlavadi crss nekal Taluk angalre bttle; 30, 60; Lamivudine (3TC) 150 mg spen Pharmacare. Prt Elizabeth, Krsten Suth frica Metallised lay flat pack, PP bttle 60 Lamivudine (3TC) 150 mg Cipla. Ga; Meditab Specialities, Ga ttle 30, 60 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 30/56

31 Lamivudine (3TC) 150 mg urbind Pharma Unit III Survey N. 313, achupally, Mandal, Hyderabad, ndhra Pradesh, ttle; 60; Lamivudine (3TC) 150 mg Film cated ViiV HealthCare - Glax Operatins UK,, Ware, Hertfrdshire, UK; GSK, Pznan (packaging and release), Pland Pharmacare (SPEN), Prt Elizabeth, UK Suth frica bttle 60 Lamivudine (3TC) 150 mg Heter labs limited - Unit-III, Jeedimetla, Hyderabad, ndhra Pradesh, ; STD-VN Jint Venture C,, Dung Prvince, Vietnam Vietnam ttle, 60, 600 ; Lamivudine (3TC) 150 mg Micrlabs H644 Verna, Ga lu/pvc/pv dc blister ttle 6x 60 Lamivudine (3TC) 150 mg Lamivudine (3TC) 150 mg Sun Pharmaceutical Industries lkem Labratries - Panta Sahib, Himachal Pradesh ttle, maliya, Daman ttle 60 Lamivudine (3TC) 150 mg Micrlabs Verna, Ga bttle 60, 30, 60, 90 Lamivudine (3TC) 150 mg Centaur Pharmaceutical Private itech Park Hinjewadi Phase II Pune, bttle 60 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 31/56

32 Lamivudine (3TC) 150 mg MYLN 63 Lamivudine (3TC) 300 mg MYLN - Lamivudine (3TC) 300 mg urbind Pharma ND# ND USFD 2, F- 4 & F-12, MIDC, Malegan, Sinnar, Nashik , F- 4 & F-12, MIDC, Malegan, Sinnar, Nashik Unit III Survey N. 313, achupally, Mandal, Hyderabad, ndhra Pradesh, PVC/PVDC/ luminium) bttle PVC/PVDC/ luminium) ; bttle ttle; x1 ; 60x1 x1 ; 60x1 30; Lamivudine (3TC) 300 mg Cipla. Ga ttle 30,60 Lamivudine (3TC) 300 mg Film cated Strides rclab 36/7, Suragajakkanahalli Indlavadi crss nekal Taluk angalre ttle, 30; 60 Lamivudine (3TC) 300 mg Macleds - Kachigam, Daman ttle; 30; 3* ; 6* Lamivudine (3TC) 300 mg Glax SmithKline. Greenfrd, Middlesex UK High density plyethylene () bttle 30 Lamivudine (3TC) 300 mg Heter labs limited Unit III 22-1, I.D.., Jeedimetla Jeedimeta, Hyderabad bttle 30, 600 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 32/56

33 Lamivudine (3TC) 300 mg Micrlabs Verna, Ga Lamivudine + Nevirapine 30 mg + 50 mg + + Stavudine 6 mg Lamivudine + Nevirapine 60 mg + 0 mg + Stavudine + 12 mg Lamivudine + Nevirapine + Stavudine Lamivudine + Nevirapine + Stavudine Lamivudine + Nevirapine + Stavudine Lamivudine + Nevirapine + Stavudine 150 mg +200 mg+ 30 mg 150 mg +200 mg+ 30 mg 150 mg +200 mg+ 30 mg 150 mg +200 mg+ 30 mg Dispersible Dispersible Cipla. - Cipla. - Cipla. - Emcure Macleds Plt N. L-139, L146- Verna, Ga Plt N. L-139, L146- Verna, Ga Kurkumbh, Patalganga, ; Plt 136,146(UNITIII&IV), L147,L147-1 UNIT-VII- Ga,; Himachal Pradesh, ; Cipla Indre, SEZ, Pithampur, Dist Dhar (M.P.), bttle 30, 60, 90 bttle 60, 00 ttle 60, 00 bttle 30; 60; 00 Hinjwadi, Pune bttle 60 ttle 60 Kachigam, Daman ttle 60 Lamivudine + Nevirapine + Stavudine 150 mg +200 mg+ 30 mg Strides rclab 36/7, Suragajakkanahalli Indlavadi crss nekal Taluk angalre ttle 60 Lamivudine + Nevirapine + Stavudine 150 mg +200 mg+ 30 mg Pharmacare. Strides, anglre ttle 60 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 33/56

34 67 Lamivudine + Nevirapine + Zidvudine 30mg+ 50mg +60mg Dispersible - Sinnar, Nashik District,, ; Waluj, urangabad,, ttle 60 Lamivudine + Nevirapine + Zidvudine 30mg+ 50mg +60mg fr Oral Suspensin Strides rclab - 36/7, Suragajakkanahalli, Indlavadi crss, nekal Taluk, angalre ttle 60 Lamivudine + Nevirapine + Zidvudine 30mg+ 50mg +60mg fr Oral Suspensin Cipla. Plt N. L-147, L147-1 (Unit VII), Verna Industrial Estate, Verna Salcette Ga, ttle 60, Lamivudine + Nevirapine + Zidvudine 150 mg mg mg - Sinnar Nashik, Maharastra; Waluj, urangabad,, ; Missin Vivacare, Pithampur, Dhar, M.P., ; Shasun Pharmaceutical, Periyakalapet, Puducherry bttle ; PVC/PVdC/ lu blister; 60; 6 X ; Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 34/56

35 Lamivudine + Nevirapine + Zidvudine 150 mg mg mg Cipla. - Cipla, Ga,UNIT- III & UNIT-IV ; Cipla, Indre, SEZ; Mylan Pithambur, Dhar Dist., Madhya Pradesh; Quality Chemical Industries, Kampala, Uganda; Cipla addi, Himachal Pradesh, Uganda bttle 30, 60, 500 Lamivudine + Nevirapine + Zidvudine 150 mg mg mg Heter labs limited - Unit-III, Jeedimetla, Hyderabad, ndhra Pradesh, ; Unit-V, Mahabb Nagar, ndhra Pradesh ; bttle ; 60, 0, 500 Lamivudine + Nevirapine + Zidvudine Lamivudine + Nevirapine + Zidvudine 150 mg mg mg 150 mg mg mg Sun Pharmaceutical Industries Macleds - Panta Sahib, Himachal Pradesh; Shasun Pharmaceutical, Puducherry, Kachigam, Daman addi, H.P. ttle /PVdc/PVC blister 60, ttle 60 Lamivudine + Nevirapine + Zidvudine 150 mg mg mg urbind Pharma Unit III, Survey N. 313 &314 achupally, Mandal Hyderabad, ndhra Pradesh Unit-VII (SEZ), Mahabb Nagar (DT), ndhra Pradesh ttle; 60; Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 35/56

36 Lamivudine + Nevirapine + Zidvudine 150 mg mg mg Film cated Strides rclab - 36/7, Suragajakkanahalli Indlavadi crss nekal Taluk angalre bttle Lamivudine + Stavudine 30 mg + 6mg fr Oral Suspensin Cipla. - L-139 t L-146, UNIT- III & VI, Verna Ga bttle; 30, 60, 00; Lamivudine + Stavudine 60 mg + 12mg fr Oral Suspensin Cipla. - L-139 t L-146, UNIT- III & VI, Verna Ga bttle; 30, 60, 00; Lamivudine + Stavudine 150 mg + 30 mg Cipla. - Patalganga, L-139 t L-146, UNIT- III & VI, Verna Ga bttle 60, 30, 00 Lamivudine + Stavudine 150 mg + 30 mg Strides rclab 36/7, Suragajakkanahalli Indlavadi crss nekal Taluk angalre ttle 60 Lamivudine + Stavudine 150 mg + 30 mg Macleds Kachigam, Daman ttle 60 Lamivudine + Stavudine 150 mg + 30 mg Heter labs limited Unit III 22-1, I.D.., Jeedimetla Jeedimeta, Hyderabad ttle 30, 60, 0, 500 Lamivudine + Stavudine 150 mg + 30 mg Pharmacare. Strides, anglre ttle 60 Lamivudine + Tenfvir disprxil fumarate 75 mg + 75 mg Heter labs limited ND Unit III Plt N. 22-1, I.D.., Jeedimetla, Hyderabad , Telangana ttle 30 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 36/56

37 70 Lamivudine + Tenfvir disprxil fumarate 300 mg mg Heter labs limited - Unit-III, 22-1, Industrial Develpment rea, Jeedimetla, Hyderabad; and Unit V Mahabb Nagar Dist, ndhra Pradesh. ttle 30, 60, 0, 500 Lamivudine + Tenfvir disprxil fumarate 300 mg mg - bttle 30, 0 Lamivudine + Tenfvir disprxil fumarate 300 mg mg urbind Pharma Unit-VII (SEZ), Mahabb Nagar (DT), ndhra Pradesh bttle 30 Lamivudine + Tenfvir disprxil fumarate 300 mg mg Cipla. H666 Peninsula usiness Park, Ganpatra Kadam Marg, Lwer Parel, Mumbai,, ,, Film cated ttle,hdp E 30x1;,lu/ lu x1;,lu/ PVC-CLR x1 Lamivudine + Tenfvir disprxil fumarate 300 mg mg Cipla. - D-7 MIDC Kurkumbh; Quality Chemical Industries, Kampala, Uganda ttle 30, 500 Lamivudine + Tenfvir disprxil fumarate Lamivudine + Tenfvir disprxil fumarate 300 mg mg 300 mg mg Sun Pharmaceutical Industries Macleds - - Shasun Kachigam- Daman addi- Himachal Pradesh ttle 30 ttle 30 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 37/56

38 Lamivudine + Tenfvir disprxil fumarate 300 mg mg Micrlabs Verna, Ga ttle 30, 0 71 [Lamivudine+Tenfvir] +tazanavir+ Ritnavir [300mg+300mg] +300mg+0mg Capsules+ s+ s lu/lu per c packed blister (1+1+1) per cblister; 3 blisters in a cartn 72 [Lamivudine+Tenfvir] +Nevirapine [300mg + 300mg] +200mg s ( cpackaged) - Village Theda, Pst Office Ldhimajra lu/lu ; in Cartn (1+2) per blister; 3 blisters in a cartn [Lamivudine+Tenfvir disprxil fumarate] + Nevirapine ( mg) + 200mg C-ed tablets urbind Pharma urbind Pharma, Unit VII (SEZ) ndhra Pradesh 1 cntains(4+ 2) 15 blisters in a bx. [Lamivudine+Tenfvir disprxil fumarate] + Nevirapine ( mg) + 200mg C-ed tablets Heter labs limited Heter Labs Unit III 22-1, I D, Jeedimetla, Hyderabad C 1 cntains(1+ 2) blisters in a bx. [Lamivudine+Tenfvir disprxil fumarate] + Nevirapine ( mg) + 200mg C-ed tablets Macleds Kachigam, Damam lu/lu blister ne cartn cntains ne blister f ne lamivudine/ TDF tablet and ne blister f tw nevirapine tablets 73 Lamivudine + Zidvudine 30 mg + 60 mg Dispersible - Sinnar-Nashik, Waluj, urangabad 60 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 38/56

39 Lamivudine + Zidvudine Lamivudine + Zidvudine 30 mg + 60 mg 30 mg + 60 mg Dispersible Dispersible Sun Pharmaceutical Industries Cipla. ND Panta Sahib, Himachal Pradesh L-147 t L (Unit VII), Verna Industrial Estate, Verna Salcette, Ga ttle 60 bttle; 60; Lamivudine + Zidvudine Lamivudine + Zidvudine Lamivudine + Zidvudine 75 Lamivudine + Zidvudine 30 mg + 60 mg 30 mg + 60 mg urbind Pharma - Sinnar-Nashik, Waluj, urangabad UNIT III, Survey N. 313 and 314, achupally Mandal, Hyderabad, ndhra Pradesh 30 mg + 60 mg Micrlabs Verna, Ga 150 mg mg urbind Pharma Unit III Survey, Hyderabad, ndhra Pradesh Unit-VII (SEZ), ndhra Pradesh 60 ttle; PVC/PVdC/ lu blister bttle; 60, 00; 6 x ; 60, 0, 00 60; Lamivudine + Zidvudine 150 mg mg Shanghai Desan i-pharmaceutical C H655 Shanghai Desan i- Pharmac+H309eutical C, 1479 Zhangheng Rad, China (Shanghai) Pilt Free Trade Zne, Shanghai, China bttle 60' Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 39/56

40 Lamivudine + Zidvudine Lamivudine + Zidvudine Lamivudine + Zidvudine Lamivudine + Zidvudine Lamivudine + Zidvudine 150 mg mg Cipla mg mg 150 mg mg Heter Labs mg mg ViiV HealthCare 150 mg mg Sun Pharmaceutical Industries Plt N. L-147, L147-1, Verna Ga, Indre, SEZ, Pithampur, Dist Dhar (M.P.), ; Quality Chemical Industries, Kampala, Uganda; Cipla addi, Himachal Pradesh, Meditab Specialities Pvt, Kundaim, Ga Unit-III, 22-1, Jeedimetla, Hyderabad Unit-V, Hyderabad Glax Operatins UK,, Ware, Hertfrdshire, UK; GSK, Pznan (packaging and release), Pland Panta Sahib, Himachal Pradesh Uganda UK bttle ; bttle ; bttle ; ttle, bttle; lu/p/pvc ; PVdC/PVC blister 60, 00 ;, 14 60, 500 ; 60; 60, 60 60; Lamivudine + Zidvudine 150 mg mg Film cated Strides rclab - 36/7, Suragajakkanahalli Indlavadi crss nekal Taluk angalre bttle 60 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 40/56

41 Lamivudine + Zidvudine 150 mg mg Universal Crpratin Kikuyu Kenya 60 Lamivudine + Zidvudine 150 mg mg Micrlabs Verna, Ga bttle; PVDC/PVC/ lu blister; 30, 60, 90; *; Lamivudine + Zidvudine Lamivudine + Zidvudine 150 mg mg Pharmacare. 150 mg mg Macleds - Prt Elizabeth, Krsten Kachigam, Daman addi, H.P. Suth frica 60 ttle; 60; 6*, 12* Lamivudine + Zidvudine 150 mg mg Emcure Hinjwadi, Pune bttle Lamivudine + Zidvudine [Lamivudine + Zidvudine] + Nevirapine 150 mg mg Lupin [150mg+300mg] +200mg C packaged Heter labs limited Dhar, Pithampur, Madhya Pradesh; Verna, Salcette Ga, Unit III 22-1, Industrial develpment rea, Jeedimetla, Hyderabad bttle 60 PVC/lu ; dses n ne blister sheet and 6 sheets included in the cartn 77 [Lamivudine + Zidvudine] + Nevirapine [150mg+300mg] +200mg C packaged Pharmacare. Fairclugh Rad, Krsten, Prt Elizabeth, 6020, Suth frica cards. Each card cntains 6 lamivudine / zidvudine tablets and 6 nevirapine tablets. Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 41/56

42 [Lamivudine + Zidvudine] + Nevirapine [150mg+300mg] +200mg C packaged Strides rclab 36/7, Suragajakkanahalli Indlavadi crss nekal Taluk angalre ttle (60) Lpinavir (LPV) + Ritnavir (RTV) Lpinavir (LPV) + Ritnavir (RTV) Lpinavir (LPV) + Ritnavir (RTV) (80 mg + 20 mg) / ml (80 mg + 20 mg) / ml (80 mg + 20 mg) / ml 79 Lpinavir+Ritnavir 40mg/mg 80 Lpinavir (LPV) + Ritnavir (RTV) Lpinavir (LPV) + Ritnavir (RTV) Lpinavir (LPV) + Ritnavir (RTV) Lpinavir (LPV) + Ritnavir (RTV) Lpinavir (LPV) + Ritnavir (RTV) Oral Slutin Oral Slutin Oral Slutin Pellets in Capsule 0 mg + 25 mg 0 mg + 25 mg 0 mg + 25 mg 0 mg + 25 mg 0 mg + 25 mg bbtt Labratries. bbtt Labratries. Cipla. Cipla. bbtt Labratries. bbtt Labratries. urbind Pharma Macleds - Queensbrugh, Kent UK PET bttle 60ml, 160ml Nrth Chicag Illinis,US PET bttle 160ml ND Plt N. L-139, S-3 & M-62, Verna Industrial Estate, Verna Salcette, Ga Plt L147 t L-147-1, Verna Industrial Estate, mber clured PET ttle 160ml ttle 120 Ludwigshafen Germany bttle 60 Nrth Chicag Illinis,US bttle 60 - H429 ND#7907 4, F-4, F-12, Malegan M.I.D.C, Sinnar, Nashik , state, Unit III Survey N. 313 and 314 achupally Mandal, Hyderabad ndhra Pradesh Slan, Himachal Pradesh ttle 60, 120 ttle; 60; 6* bttle 60 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 42/56

43 81 Lpinavir (LPV) + Ritnavir (RTV) Lpinavir (LPV) + Ritnavir (RTV) 0 mg + 25 mg Heter labs limited mg mg Capsule bbtt Labratries. ND Heter labs (Unit-III), Jeedimetla,Hyderabad bttle 60; 120 RP Scherer, Flrida US bttle 90 Lpinavir (LPV) + Ritnavir (RTV) mg mg Capsule Sft bbtt Labratries. Queenbrugh, Kent UK ttle () ttle (PVC) 90, Lpinavir (LPV) + Ritnavir (RTV) Lpinavir (LPV) + Ritnavir (RTV) Lpinavir (LPV) + Ritnavir (RTV) 200 mg + 50 mg 200 mg + 50 mg 200 mg + 50 mg bbtt Labratries. urbind Pharma - ttle; 120; Ludwigshafen Germany bttle 120 Unit III Survey N. 313 and 314 achupally Mandal, Hyderabad ndhra Pradesh ttle; 120; 6* Lpinavir (LPV) + Ritnavir (RTV) 200 mg + 50 mg Cipla. -42, MIDC Patalganga ttle 120, Lpinavir (LPV) + Ritnavir (RTV) Lpinavir (LPV) + Ritnavir (RTV) 83 Nevirapine (NVP) mg / ml 200 mg + 50 mg Heter labs limited mg + 50 mg Oral Suspensin Macleds ehringer Ingelheim Unit III 22-1, Industrial develpment rea, Jeedimetla, Hyderabad Slan, Himachal Pradesh Rxane, Clumbus, US lu/lu lu/pvc/pv dc blister 60, 120 bttle 120 bttle+ syringe 240ml + 5ml Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 43/56

44 Nevirapine (NVP) Nevirapine (NVP) mg / ml 50 mg /5 ml Oral Suspensin Oral Suspensin Cipla. urbind Pharma 84 Nevirapine 20mg Micrlabs 85 Nevirapine (NVP) 50mg Nevirapine (NVP) Nevirapine (NVP) 50mg 50mg fr Oral Suspensin fr Oral Suspensin Dispersible tablet urbind Pharma Cipla. - Sun Pharmaceutical Industries 86 Nevirapine 50mg Micrlabs 87 Nevirapine (NVP) 0mg fr Oral Suspensin Cipla. - Cipla, Ga, ; Meditab Specialties Pvt,, ; Indre, SEZ, Pithampur, Dist Dhar (M.P.) Unit III Survey N. 313 and 314 achupally Mandal, Hyderabad ndhra Pradesh Plt N: S-155 t S- 159, Phase III, Verna Industrial Estate, Verna, Ga Unit III Survey N. 313 and 314 achupally Mandal, Hyderabad ndhra Pradesh -42, MIDC, Patalganga Panta Sahib, Himachal Pradesh Plt N: S-155 t S- 159, Phase III, Verna Industrial Estate, Verna, Ga , MIDC, Patalganga mber clured PET ttle mber clured glass bttle bttle bttle 0ml, ml, ml 240ml 0ml 30,60,90 bttle 30, 180 bttle 60, 00 bttle 60 bttle bttle 30,60,90 60, 00 Editin: Versin 147, 15th f June 2018 List f IDS drugs classified accrding t the GF Q Plicy 44/56