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

Transcription

1 List Of Tuberculosis Pharmaceutical Products classified according to the Global Fund Quality ssurance Policy Edition: Version 95-18th of December 2018 The list is an overview of pharmaceutical products subject to the Global Fund Quality ssurance Policy that are listed in National and/or standard treatment guidelines and classified according to the various options (,, and ERP reviewed) defined in the Global Fund Quality ssurance Policy (July 2009, amended in December 20). 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 ssurance Policy. The pharmaceutical products are classified based on the following information classified product - Listed on prequalification list; classified product - Stringent NDR Registration letter/marketing uthorization; 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. PR can procure product(s) not listed in the current list as long as PR demonstrates that the product is compliant with the Global Fund Quality ssurance Policy. The Global Fund list includes the following information: - "Important Notes" for helpful information; -,, and ERP reviewed products; - Period validity of the ERP reviewed products; - "+" means combination product, both fixed-dose combination (co-formulated) and co-packaged product ( i.e. co-blister) - [+]+C means and are in fixed-dose formulation and C is co-packaged YELLOW signifies a new entry; PINK signifies modification of an existing entry. For more information, please look at: 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 ssurance 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 ssurance 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 ssurance 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. List of T drugs classified according to the GF Q Policy 1/22

2 ccording to the Global Fund Q policy, if there are two or more or classified manufacturers available for any given product ND 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 or 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 ). 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 s while within liquids, oral solution and suspension are grouped together.similarly, the entero coated or dispersible will not share the same reference number as non entero coated or dispersible s. Ref.No Non- International proprietary name Strength Dosage form Supplier/Manufacturer* Global Fund Q Prequalified/ SR Manufacturing site* Country Material Pack XYZ 50mg "Pharma Company " - "Pharmaville" Country bottle mg "Pharma Company " - "Pharmaville" Country bottle 60 The example above shows 2 different variants of the same medicine. ecause 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. and liquid) it would also have been considered two different "products". Ref.No Non- International proprietary name Strength Dosage form Supplier/Manufacturer* Global Fund Q Prequalified/ SR Manufacturing site* Country Material Packaging Pack 25 C 150mg "Pharma Company " - "Pharmaville" Country, bottle, 60 Capsules "Pharma Company " - "Pharmaville" Country ottle, 60, 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/IDS, 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. List of T drugs classified according to the GF Q Policy 2/22

3 List of or products: If there are two or more or products available, then the product must be procured from one of the or 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. Ref.No Global Fund Q SR 1 mikacin ( as sulfate) 500 mg/2ml Injection Cipla Goa Glass vial 2ml Injection for Fisio Pharma mikacin ( as sulfate) 500 mg/2ml Pharmatex, Italy Italy Glass Vial x 2ml IM/IV use Palomonte mikacin 500 mg/2ml Injection, for IM/IV use Medochemie Limassol Cyprus Glass vial, ampoules Pack of, 0 mikacin 500 mg/2ml Injection, for IM/IV use Vianex Vianex S.. - Plant ', ttiki, Greece Greece Glass Vial 1x2ml mikacin ( as sulfate) 500 mg/2ml Injection Pharmathen Hellas S.. Pharmathen S., Pallini ttiki, Greece; DEMO S.. Krioneri ttiki, Greece Greece Glass ampoule 2ml 1, 5 or ampoules per carton mikacin ( as sulfate) 500 mg/2ml Solution for Injection Qilu Pharmaceutical Co.,, T319 Qilu Pharmaceutical Co.,., No. 317, Xinluo Road, Hightech Zone, Jinan, Shandong, 2501 China Glass ampoule 2ml x1 2 moxycillin + Clavulanic acid moxycillin + Clavulanic acid moxycillin + Clavulanic acid 3 moxycillin + Clavulanic acid moxycillin + Clavulanic acid 250mg : 62.5mg/ 5ml 250mg mg/ 5ml 250mg mg/ 5ml 125mg mg/ 5ml 125mg mg/ 5ml oral susp oral susp oral susp oral susp oral susp Glaxo SmithKline. Middlesex UK ottle 0ml rown & urk UK Medreich UK Micro Labs, Veersandhra, nekal, angalore Medreich Virgonagar angalore bottle 0ml Glass bottle 0ml with measure cup Glaxo SmithKline. Middlesex UK ottle 0ml rown & urk UK Micro Labs, Veersandhra, nekal, angalore bottle 0ml List of T drugs classified according to the GF Q Policy 3/22

4 moxycillin + Clavulanic acid 125mg mg/ 5ml oral susp Medochemie, Limassol (Cyprus) Global Fund Q SR 4 moxycillin + Clavulanic acid 250mg+125mg rown & urk UK No Medochemie, Limassol Micro Labs, Veersandhra, nekal, angalore Cyprus bottle 0ml moxycillin + Clavulanic acid 250mg+125mg Remedica Limassol Cyprus lu/ lu 5 moxycillin + Clavulanic acid 500mg + 125mg moxycillin + Clavulanic acid 500mg+125mg rown & urk UK Remedica Limassol Cyprus lu/ lu Micro Labs, Veersandhra, nekal, angalore 8,, 14, 16, 21 (2x s in carton box) (2x s in carton box) 8,, 14, 16, 21, 50 & 0 s moxycillin + Clavulanic acid 500mg+125mg Medochemie Limassol Cyprus l/pvc 16, 20, 0 moxycillin + Clavulanic acid 500mg+125mg Reig Jofre Toledo Spain 6, 12(2*6), 24(4*6) ottle 500 moxycillin + Clavulanic acid 500mg+125mg Glaxo SmithKline. Middlesex, Worthing UK 14 6 moxycillin + Clavulanic acid 875mg + 125mg Medochemie Limassol Cyprus l/pvc 14 moxycillin + Clavulanic acid 875mg + 125mg Reig Jofre Toledo Spain ottle 6, 12(2*6), 24(4*6) 500 moxycillin + Clavulanic acid 875mg + 125mg Glaxo SmithKline. Middlesex UK 14 moxycillin + Clavulanic acid 875mg+125mg rown & urk UK Micro Labs, 2x7, 3x7, 5x5, Veersandhra, x nekal, angalore Medreich moxycillin + Clavulanic acid 875mg+125mg Medreich UK Virgonagar, angalore PVC/lu blister 2x8(16) 7 edaquiline Fumarate * 0mg (ase) Janssen Cilag, elgium 8 Capreomycin Capreomycin Capreomycin Capreomycin Capreomycin powder for powder for powder for for IM use powder for powder for Recipharm Pharmaservices private ottle korn korn, Illinois US Glass vial 1, 1* King Pharmaceuticals Limited Vianex Hisun Pharmaceutical (Hangzhou) Co spen Pharmacare Vianex S.. - Plant C', 16th km Marathonos ve., Pallini, ttiki, Vianex S.. - Plant C', 16th km Marathonos ve., Pallini, ttiki, Fuyang, Hangzhou City, Zhejiang Province Korsten, Port Elizabeth Greece Glass vial 1 Greece Glass vial 1 China Glass vial 1 South frica Glass vial 1 List of T drugs classified according to the GF Q Policy 4/22

5 Capreomycin, Mumbai () Global Fund Q SR T 211 Macleods Pharmaceutical, Kachigam, Daman Glass vial 1 Capreomycin NCPC International Corp., China (People's Republic of) T316 North China Pharmaceutical Co, New Preparation ranch Factory, No. 115 Hainan Road, Shijiazhuang Economic & Technological Development Zone, Shijiazhuang, Hebei China Glass vial vialx Capreomycin (sulfate) Mylan Laboratories T329 Mylan Laboratories Limited [HSF], Plot No. 14, Sipcot II, Krishnagiri Road, Hosur, Type 1 glass vial x1 Capreomycin (sulfate) 0.5g 9 Clarithromycin 250mg Injection s. T337 Macleods Pharmaceuticals, Unit 2, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam, Daman, Glass vial ml Remedica Limassol Cyprus lu/pvc 7 (2*7 s in carton box) Clarithromycin 250mg Medochemie Limassol Cyprus 14 PVC/PVdC lu 6,7,8,,12,14 Clarithromycin 250mg Micro Labs Hosur, Tamilnadu bottle,16,20 0,500 Clarithromycin 250mg HEC Pharm GmbH, Sunshine Lake Pharma Co.,. China Clarithromycin 250mg Clarithromycin 500mg Sunshine Lake Pharma Co.,. DongGuan, GuangDong Province China PVC/PVDC/lu strip Remedica Limassol Cyprus lu/pvc Clarithromycin 500mg Medochemie Limassol Cyprus 14 6,, 12,14, 15, 16, 20, 24 7 (2*7 s in carton box) List of T drugs classified according to the GF Q Policy 5/22

6 Global Fund Q SR Clarithromycin 500mg Strandhaven UK Essex UK 14 Clarithromycin 500mg Micro Labs Hosur, Tamilnadu lu/pvc 6,7,8,,12,14,16,20 0,500 Clarithromycin 500mg HEC Pharm GmbH, Sunshine Lake Pharma Co.,. China Clarithromycin 500mg DongGuan, Sunshine Lake Pharma PVC/PVDC/lu, 14, 16, GuangDong China Co.,. strip 20, 42, 0 Province Waluj, Clarithromycin 500mg Mylan Laboratories urangabad, Maharashtra bottle Clofazimine * 50mg Capsule Novartis, Switzerland Sandoz, Kalwe ottle 0 Clofazimine * 0mg Capsule Novartis, Switzerland Sandoz, Kalwe ottle 0 Cycloserine 125 mg Capsule T330 Unit 2, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam, Daman, lu/lu blister; lu/lu strip x 12 Cycloserine 250 mg Capsule Cycloserine 250 mg Capsule Dong- Pharmaceutical Co Cycloserine 250 mg Capsule Chao Centre Kachigam, Daman Solan Himachal Pradesh Dong- Pharmaceutical Co Cheonan, Chungcheongnamdo Chao Centre na l Strip Republic of Korea lu/lu strip x US ottle 40 Cycloserine 250 mg Capsule iocom JSC Stavropol Russia ottle 0 Cycloserine 250 mg Capsule Cipla Verna Salcette, Goa ottle 40 Cycloserine 250 mg Capsule Strides Shasun T306 Strides Shasun, Unit II, RS No 32-34, PIMS Road, Periyakalapet, Puducherry, ottle lu/lu 40x1 x Cycloserine 250 mg Capsule Mylan Laboratories T304 Plot No H-12 & H13 MIDC Waluj Industrial rea, urangabad, Maharashtra, ottle ; lu/lu 0x1; x1 List of T drugs classified according to the GF Q Policy 6/22

7 13 Delamanid * 50mg Otsuka Novel Products GmbH, Global Fund Q SR ndersonrecon (UK). 14 Ethambutol 0 mg Labatec Pharma Meyrin, Geneva Ethambutol 0 mg SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) Ethambutol 0 mg UK Switzerlan d Kachigam Damam ottle lu/lu strip PVC/lu ottle PVC/clar/PVC /lu blister l/pvc/pvdc blister 50, 300 5x8tab(40) 6x8 tab(48) * 0 50, 0, 500 x, 24 x 28; bottle Ethambutol 0mg disp T334 Unit II, Plot No Sr. No. 366, Kachigam, Daman pack lu/lu strip pack x 6x 15 Ethambutol 250 mg 16 Ethambutol 400 mg SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) Cadila Pharmaceuticals Dholka, hmedabad, PVC/lu blister 0, 500 lu/pvc/pvdc ; bottle, 28; ;, 28; Ethambutol 400 mg Kachigam, Daman ottle Ethambutol 400 mg OlainFarm JSC Olaine Latvia ottle Chikalthana, PVC/PVDC/lu 28,; urangabad blister ; Ethambutol 400 mg Lupin ari 0, 500, rahmana, Jammu bottles (J & K) Switzerlan Ethambutol 400 mg Labatec Pharma Meyrin, Geneva PVC/lu * d Ethambutol 400 mg Svizera Europe V Svizera Labs Pvt, Plot No D16/6 TTC Industrial rea, MIDI, Turbhe, Navi Mumbai, ottle ; 28x24, 0 Ethambutol 400 mg SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) PVC/lu blister 0, 500 Ethambutol 400 mg S.C. ntibiotice S. Lasi Romania lupvc 17 Ethambutol 500 mg 18 Ethambutol + Isoniazid 400 mg mg SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) Kachigam, Daman 2x 150x PVC/lu blister 0, 500 lu/pvc/pvdc ; bottle, 28; List of T drugs classified according to the GF Q Policy 7/22

8 Ethambutol + Isoniazid 400 mg mg 19 Ethambutol + Isoniazid + Rifampicin Ethambutol + Isoniazid +Rifampicin 275 mg+75 mg+150 mg 275mg +75mg +150mg s Cadila Pharmaceuticals Global Fund Q SR Dholka, hmedabad, Kachigam, Daman; Oxalis lab, Solan, addi Lupin urangabad PVC/PVdcV/ lu blister container; lu/pvc/pvdc ottle lu/pvc/pvdc blister, 28 ;, Ethambutol + Isoniazid +Rifampicin 275mg +75mg +150mg Svizera Europe V T192 Svizera Labs Pvt, Plot No D16/6 TTC Industrial rea, MIDI, Turbhe, Navi Mumbai, ottle ; lu/pvc/pvdc x1; 28x24 20 Ethambutol + Isoniazid + Pyrazinamide + Rifampicin Ethambutol + Isoniazid + Pyrazinamide + Rifampicin Ethambutol Hydrochloride+ Isoniazid + Pyrazinamide + Rifampicin 275 mg + 75 mg mg mg 275 mg + 75 mg mg mg 275 mg + 75 mg mg mg Lupin Micro Labs T223 Chikalthana urangabad Kachigam, Daman; Oxalis lab, Solan, addi Kumbalgodu, angalore, Karnataka, ; bottle container; lu/pvc/pvdc lu/lu strip ottle 4, 28;672 0, 500, 500, ;, 28 x, 24x Ethambutol Hydrochloride+ Isoniazid + Pyrazinamide + Rifampicin 275 mg + 75 mg mg mg Svizera Europe V T193 Svizera Labs Pvt, Plot No D16/6 TTC Industrial rea, MIDI, Turbhe, Navi Mumbai, ottle ; lu/pvc/pvdc x1; 28x24 Ethionamide 125 mg Ethionamide 125 mg Dispersible, Mumbai (), Mumbai () T314 Kachigam, Daman lu/lu strip x T333 Kachigam, Daman lu/lu strip 6x5 Ethionamide 125 mg Micro Labs T331 Unit 03, 92 Sipcot Industrial Complex, Hosur, Tamil Nadu ottle lu/pvc- PVdC 0x1; x;x14 21 Ethionamide 250 mg Kachigam, Daman Oxalis lab, Solan, addi ; Strip 0; List of T drugs classified according to the GF Q Policy 8/22

9 Ethionamide 250mg Global Fund Q SR Cipla Patalganga Ethionamide 250mg Lupin urangabad Ethionamide 250mg Micro Labs Hosur, Tamilnadu 22 Imipenum+Cilastatin 250mg/250mg 23 Imipenum+Cilastatin 500mg/500mg Imipenum+Cilastatin Imipenum+Cilastatin Imipenum+Cilastatin Imipenum+Cilastatin Panpharma 500mg/500mg 500mg/500mg 500mg/500mg 500mg/500mg solution for infusion Injection Injection solution for infusion solution for infusion solution for infusion ottle; lu/pvc/pvdc lsiter ottle ; L/L Strip ottle ; PVDC/PVC/L Strip 0; 0; 5x Fresenius Kabi Runcorn, Cheshire UK Glass vial x 20ml Labatec Pharma DEMO S Pharmaceutical Industry nfarm Facta Farmaceutici CS Dobfar Greece Italy Italy ttiki Greece Glass vials in carton box Glass vial in carton box 0; 1;;50 Fresenius Kabi Runcorn, Cheshire UK Glass vial x 20ml Sun Pharmaceutical Industries 24 Isoniazid 50 mg SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) 25 Isoniazid 0 mg PNMEDIC, France Isoniazid 0 mg SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) Madhya Pradesh Glass vial x 30ml FCT FRMCEUTICI S.p. Kachigam, Daman Oxalis lab, Solan, addi Isonazid 0mg Micro Labs Hosur, Tamilnadu Isonazid 0mg Lupin Chikalthana, urangabad, Isonazid 0mg Labatec Pharma Meyrin, Geneva Italy Glass vial 20ml 1,, 25 Switzerlan d PVC/clar/PVC /lu blister Container; PVC/PVdc PVC/clar/PVC /lu blister Container l/pvc/pvdc blister bottle PVC/lu ottle Isonazid 0mg S.C. ntibiotice S. Lasi Romania lupvc 26 Isoniazid 200 mg SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) PVC/clar/PVC /lu blister 0, 500 ;, 28 0, 500 * (0) 0, * 0 2x 150x 0, 500 List of T drugs classified according to the GF Q Policy 9/22

10 27 Isoniazid 300 mg Global Fund Q SR Kachigam, Daman Oxalis lab, Solan, addi Isoniazid 300 mg Micro Labs Hosur, Tamilnadu Container ; PVC/PVdC/lu Container Isonazid 300mg S.C. ntibiotice S. Lasi Romania lupvc Isonazid 300mg 28 Isoniazid + Rifampicin 30mg+ 60mg Isoniazid + Rifampicin 30mg+ 60mg 29 Isoniazid + Rifampicin 60mg + 60mg Dispersible DispersibleT ablet Dispersible Cadila Pharmaceuticals Lupin 30 Isoniazid + Rifampicin 75 mg mg Lupin Isoniazid + Rifampicin 75 mg mg Dholka, hmedabad Kachigam, Daman Chikalthana, urangabad; ari rahmana, Jammu (J&K) Kachigam, Daman Chikalthana urangabad Kachigam, Daman; Oxalis lab, Solan, addi PVC-PVDC/lu blister ; bottle container; lu/pvc/pvdc ;, 28 3x 150x x,24x28 500, ;, 28 l/l strip 15x6; 14x6 container; lu/pvc/pvdc ; bottle ottle; lu/pvc/pvdc ;, 28 15; 0, 500, 500, ;, 28 Isoniazid + Rifampicin 75 mg mg Svizera Europe V T189 Svizera Labs Pvt, Plot No D16/6 TTC Industrial rea, MIDI, Turbhe, Navi Mumbai, ottle ; lu/pvc/pvdc x1; 28x24 31 Isoniazid+Rifampicin 150mg+150mg Lupin urangabad $ 32 Isoniazid + Rifampicin 150 mg mg Grouppo Lepetit Isoniazid + Rifampicin Isoniazid + Rifampicin 150 mg mg 150 mg mg nagni 28 Italy 8, 24 Remedica Limassol Cyprus PP/PE ottle 0 SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) PVC/lu blister 0, 500 Isoniazid + Rifampicin 150 mg mg Capsule S.C. ntibiotice S. Lasi Romania lupvc 1x 0x List of T drugs classified according to the GF Q Policy /22

11 Isoniazid + Rifampicin 150 mg mg 33 Isoniazid + Pyrazinamide+Rifampicin 30 mg+ 150 mg+60mg Dispersible Global Fund Q SR T231 Kachigam, Daman Kachigam, Daman ottle; PVC/PVDC/ lu blister container; lu/pvc/pvdc,500; x, 3x28, 24x28 ;, 28 Isoniazid + Pyrazinamide+Rifampicin 30 mg+ 150 mg+60mg Dispersible Lupin Chikalthana, urangabad, ; ari rahmana, Jammu (J&K), l/l strip 15x6; 14x6 Isoniazid + Pyrazinamide+Rifampicin 50 mg+ 150 mg+75mg Dispersible T309 Unit 2, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam, Daman, Strip lu/lu, ottle x, 0 34 Kanamycin Kanamycin (sulfate) powder for powder for Panpharma Laboratory Fougeres France Glass vial 50 T213 Unit 2, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam, Daman, Glass vial ml 1 Kanamycin (acid sulfate) powder for Hisun Pharmaceutical (Hangzhou) Co T301 Xialian Village, Xukou Town, Hangzhou City, Zhejiang Province China Vial Glass Type I 1x1 Kanamycin (sulfate) 500mg powder for T212 Unit 2, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam, Daman, Glass vial ml 1 Kanamycin (acid sulfate) 500mg powder for Hisun Pharmaceutical (Hangzhou) Co T300 Xialian Village, Xukou Town, Hangzhou City, Zhejiang Province China Vial Glass Type I 1x1 35 Kanamycin /4ml Levofloxacin 0mg solution for - Route of administratio n:im Dispersible Meiji Seika Pharma Tokyo Japan Glass ampoule Macleods T326 lock N2 Village Theda, P.O. Lodhimajra, Tehsil addi, District:-Solan Himachal Pradesh pack lu/lu strip pack x x List of T drugs classified according to the GF Q Policy 11/22

12 Global Fund Q SR 36 Levofloxacin 250mg Cipla Goa ottle; lu/pvc 50; * Levofloxacin 250mg Hetero Labs Hetero Labs Limited UNIT- V, TSIIC Formulation SEZ, Sy No. 439, 440, 441 & 458, Polepally Village, Jadcherla Mandal, Mahaboobnagar District, Telangana lu/pvc 3*1, 5*1, 7*1, *1,14*1, 50*1, 200*1 Levofloxacin 250mg Micro Labs Hosur, Tamilnadu PVC/lu blister x Levofloxacin 250mg Denk Pharma GmbH & Co Rottendorf Pharma GmbH, Ennigerloh, 3, 5, 7, Levofloxacin 250mg Medochemie Limassol Cyprus Levofloxacin 250mg Levofloxacin HEC Pharm 250mg HEC Pharm GmbH, Solan, Himachal Pradesh, Sunshine Lake Pharma Co.,. 37 Levofloxacin 500mg Cipla Goa China 3,5,7, ox (x) lu/pvc blister 5's x 20 PVC/PVDC/L U- ottle; lu/pvc Levofloxacin 500mg Micro Labs Hosur, Tamilnadu PVC/lu blister x Levofloxacin 500mg Denk Pharma GmbH & Co Rottendorf Pharma GmbH, Ennigerloh 6's 50; 1* 5, 7, Levofloxacin 500mg Medochemie Limassol Cyprus Levofloxacin 500mg Levofloxacin HEC Pharm 500mg HEC Pharm GmbH, Solan, Himachal Pradesh, Sunshine Lake Pharma Co.,. China 3,5,7, ox (8x) lu/pvc blister 5's x 20 PVC/PVDC/L U- 's List of T drugs classified according to the GF Q Policy 12/22

13 Global Fund Q SR Levofloxacin 500mg Hetero Labs Hetero Labs Limited UNIT- V, TSIIC Formulation SEZ, Sy No. 439, 440, 441 & 458, Polepally Village, Jadcherla Mandal, Mahaboobnagar District, Telangana lu/pvc 1*1, 5*1, 7*1, *1,14*1, 50*1, 500*1 Levofloxacin 750mg Levofloxacin 750mg Hetero Labs, 39 Linezolid 600mg Hetero Europe SL Spain Linezolid 600mg Micro Labs T323 Solan, Himachal Pradesh, Hetero Unit V ndra Pradesh Hetero Unit V ndra Pradesh ML08, Plot No 15/, 2nd Phase, Kumbalgodu Industrial rea, angalore, lu/pvc blister 's x 5, 5, Strip,lu/lu 4x1 Linezolid 600mg Pharmacia UK Pfizer, Puurs, elgium Linezolid 600mg Teva Pharma S.L.U, Zaragoza, Spain Teva Pharmaceutical Works, Debrecen ottle 1x, 2x, 3x, 5x, 6x 30,60 Hungary Linezolid 600mg Cipla, T321 Indore, SEZ, Pithampur, Dist Dhar (M.P.), lu/pvc blister ottle x2 20x1 Linezolid 600mg Hetero Labs, T299 Linezolid 600mg Dr.Reddy s Laboratories (UK) Limited Mahaboob Nagar District, ndhra Pradesh ulk Production Polpharma S. ul.pelplinska 19, Starogard Gdanski, Poland Poland ottle op/l/pvc/l blister 20 s & 0 s units per pack in ; 20; 30; 50; 60; 0 List of T drugs classified according to the GF Q Policy 13/22

14 Global Fund Q SR Linezolid 600mg s T297 lock No. N2, Village Theda, P.O. Lodhi Majra, Tehsil addi, District Solan, Himachal Pradesh, lu/pvc Strip lu/lu x;x, 4x5 Linezolid 600mg Lupin T350 Lupin, EPIP, SIDCO Industrial Complex, Kartholi, ari rahmana, Jammu & Kashmir, lu/pvc ; lu/pvc/pvdc x 40 Linezolid 0 mg/5 ml Granules for Oral Suspension Pharmacia UK Pfizer, Puurs, elgium Glass bottle 5x240ml (66 g per bottle) x240ml (66 g per bottle) 41 Linezolid 2mg/ml Intra Venous Infusion Pharmacia UK Fresenius Kabi Norge S Norway Infusion bag 5x300ml x300ml 20x 300ml 42 Meropenem Intra Venous /Inf usion Vianex, Greece Vianex Plant D Patra, xaia Greece Glass vial 1 vial 1x vials Meropenem Intra Venous PNMEDIC, France FacT FRMCEUTICI S.p., Teramo Italy Glass vial 1 vial 1x vials Meropenem Intra Venous DEMO S Pharmaceutical Industry Greece DEMO S Pharmaceutical Industry Greece Glass vial 1 vial 1x vials Moxifloxacin( as hydrochloride) 0mg disp Micro Labs T349 Micro Labs, Unit 03, 92 Sipcot Industrial Complex, Hosur, Tamil Nadu, ; Micro Labs, ML08, Plot No 15/, 2nd Phase, Kumbalgodu Industrial rea, angalore, lu-lu strips; lu- PVC/PE/PVDC blisters x; x1, 14x1 List of T drugs classified according to the GF Q Policy 14/22

15 Global Fund Q SR Moxifloxacin( as hydrochloride) 0mg disp s T342 Macleods Pharmaceuticals, lock No. N2, Village Theda, P.O. Lodhi Majra, Tehsil addi, District Solan, Himachal Pradesh, lu/lu blister x 43 Moxifloxacin ( as hydrochloride) 400 mg Cipla Patalganga Moxifloxacin 400mg ayer Schering G Moxifloxacin 400mg Moxifloxacin 400mg Sun Pharmaceutical Industries Moxifloxacin 400mg Hetero Europe SL Moxifloxacin ( as hydrochloride) 400 mg Mylan Laboratories Limited T286 ayer Schering G Leverkusen Kachigam, Damam; Solan, addi MSN Laboratories, Medak District, ndhra Pradesh, Hetero Unit V ndra Pradesh Sinnar, Nashik, Maharashtra, ottle; 30, 0, ; 5 5 lu/lu cold form blister lu/lu strip lu/pvc/pvdc blister 5,, 20 1 x 5, 1 x, x 5,7, lu/pvc/pvdc blister ottle x 0 Moxifloxacin ( as hydrochloride) 400 mg Micro Labs, T263 Hosur, Tamilnadu PVC/PE/PVDC /lu blister; lu/lu blister; bottle x; x ; 30, 0 Moxifloxacin ( as hydrochloride) 400 mg MSN Laboratories Private Limited T341 Formulations Division, Unit-II, Survey Nos. 1277, 1319 to 1324, Nandigama (Village & Mandal), Rangareddy (District), Telangana, ottle; ;lu/pvc /PVdC 30x1, 500x1:; 5x3, 7x5, x3 Moxifloxacin ( as hydrochloride) 400 mg Hetero Labs, T315 Unit 5, Survey No 439, 440, 441 & 458 TSIIC Formulation SEZ, Polepally Village, Jadcherla (M), Mahaboob Nagar District, Telangana, lu/lu x1 List of T drugs classified according to the GF Q Policy 15/22

16 Moxifloxacin ( as hydrochloride) 400 mg Zhejiang Hisun Pharmaceutical Co Global Fund Q SR T289 1 Haizheng venue, Taizhou, Jiaojiang District, Zhejiang, Ofloxacin 200mg Cipla Patalganga Ofloxacin 200mg Micro Labs Hosur, Tamilnadu Ofloxacin 200mg Solon Himachal Pradesh Ofloxacin 200mg Remedica Limassol Cyprus 45 Ofloxacin 400mg Cipla Patalganga Ofloxacin 400mg Micro Labs Hosur, Tamilnadu Ofloxacin 400mg Remedica Limassol Cyprus 46 Para-aminosalicylate sodiam 60% w/w 47 Para-aminosalicylic cid sodiam 4g Delayed Release Granules oral solution Kachigam, Daman Solan, Himachal Pradesh China lu-pvc/pvdc x3 ottle; lu/pvc ottle; PV/lu PVC/lu blister bottle PVC/lu blister bottle ottle; lu/pvc ottle; PV/lu PVC/lu blister bottle container; Sachet x3 0, 500, ; 0 0 0,500, 0, 500, ; 0 0,500, OlainFarm JSC - Olaine Latvia ox 25, 300 Para-minoSalicylic cid 4g Granules Jacobus New Jersey US ox Prothionamide 250mg OlainFarm JSC Olaine Latvia Prothionamide 250mg SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) - T345 Schiffweiler PVC/L blister 50, 0 Prothionamide 250mg Micro Labs Hosur Prothionamide 250mg Lupin Chikalthana, urangabad ; ottle 0g; 9.2g 14; 0 bottle 50 Pyrazinamide 150mg Dispersible s Micro Labs T335 ML08, Plot No 15/, 2nd Phase, Kumbalgodu Industrial rea, angalore, ottle; lu/lu Strip 0x1,500x1, x1 x 49 Pyrazinamide 150mg Dispersible s T307 Solan, Himachal Pradesh triple laminated bag further packed in bottle 0 50 Pyrazinamide 400 mg Cadila Pharmaceuticals Dholka, hmedabad ; bottle, 28; List of T drugs classified according to the GF Q Policy 16/22

17 Pyrazinamide 400 mg Global Fund Q SR Kachigam,Daman Oxalis lab, Solan, addi Pyrazinamide 400 mg Micro Labs Hosur, Tamilnadu 51 Pyrazinamide 500 mg Micro Labs Hosur, Tamilnadu ottle; lu/pvc/pvdc container container lu/pvc/pvdc Pyrazinamide 500 mg SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) PVC/lu blister 0, 500 Pyrazinamide 500 mg OlainFarm JSC Olaine Lativia ottle Pyrazinamide 500 mg Labatec Pharma Meyrin, Geneva Switzerlan d x Pyrazinamide 500 mg 3 x, x Kachigam Damam lu/pvc blister, 3 x 28, 24 Oxalis lab, Solan, bottle x 28; addi Pyrazinamide 500 mg S.C. ntibiotice S. Lasi Romania lupvc 2x 150x 52 Rifabutin 150mg Capsule Lupin - Chikalthana, urangabad ottle 0 53 Rifapentine 150mg Sanofi ventis, US - T366 Sanofi Sp, nagni Italy 24 (3 x 8's) 54 Rifampicin 0 mg/5ml Rifampicin 0 mg / 5 ml Granule for Syrup Granulate for oral suspension vantis Pharma SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) Gruppo Lepanti, nagni Lomapharm, 55 Rifampicin 150 mg Capsule Labatec Pharma Meyrin, Geneva Rifampicin 150 mg Capsule vantis Pharma Rifampicin 150 mg SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) Gruppo Lepanti, nagni ;,28 Italy Glass ottle; 120ml Glass bottle 0ml Switzerlan d Italy PVC/lu Rifampicin 150 mg Capsule Remedica Limassol Cyprus lu/pvc blister *8's Glass ottle; 0; 0 PVC/clar/PVC 0, 500 /lu blister (* caps in carton box) 2x 0x Rifampicin 150 mg Capsule S.C. ntibiotice S. Lasi Romania lupvc Rifampicin 150 mg Capsule T259 Kachigam, Daman ottle; lu/lu strip 0; * Rifampicin 300 mg Capsule T332 Unit 2, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam, Daman, 396 2, lu/pvc ; Strip, x; 0x1, lu/lu ; LDPE ag List of T drugs classified according to the GF Q Policy 17/22

18 Global Fund Q SR 56 Rifampicin 300 mg Capsule Labatec Pharma Meyrin, Geneva Switzerlan d PVC/lu *4's Rifampicin 300 mg Capsule vantis Pharma Gruppo Lepanti, Glass ottle; Italy nagni 0; 0 Rifampicin 300 mg SW Pharma GmbH PVC/clar/PVC (Former FTOL-(RIEMSER) rzneimittel) /lu blister 0, 500 Rifampicin 300 mg Capsule S.C. ntibiotice S. Lasi Romania lupvc 1x 0x (* Rifampicin 300 mg Capsule Remedica Limassol Cyprus lu/pvc blister caps in carton box) 57 Rifampicin 450 mg Capsule vantis Pharma Gruppo Lepanti, Glass ottle; Italy nagni 30; 8 Rifampicin 450 mg SW Pharma GmbH PVC/clar/PVC (Former FTOL-(RIEMSER) rzneimittel) /lu blister 0, Rifampicin 600 mg SW Pharma GmbH PVC/clar/PVC (Former FTOL-(RIEMSER) rzneimittel) /lu blister 0, 500 Rifampicin+Isoniazid 75mg + 50mg Disp Macleods T Streptomycin Streptomycin Streptomycin (sulfate) sterile 1 g -IM Phase II, Unit II, Plot No , Premier Ind. Estate, Kachigam, Daman (U.T). Oxalis Labs, Vill. Theda, P.O. Lodhimajra, addi, Dist. Solan (H.P.) container pack lu/lu strip pack 0 (x), 28 Panpharma Laboratory Fougeres France ottle 50 Reig Jofre NCPC International Corp. T296 Laboratorio Reig Jofré, S.. Madrid. raun Medical, S.. Jaén North China Pharmaceutical Co, New Preparation ranch Factory, No. 115 Hainan Road, Shijiazhuang, Hebei Spain Glass Vial 0 China (People's Republic of) Vial, Type III glass 1x 60 Terizidone 250mg Capsule SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) - T346 Schiffweiler 50 List of T drugs classified according to the GF Q Policy 18/22

19 * Terizidone 250mg Capsule s Global Fund Q SR T303 Macleods Pharmaceuticals, Unit 2, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam, Daman, 396 2, Container, Strip, lu/lu Conditions to be observed before procuring the products: * edaquiline: Procurement of this item is subject to compliance with recommendations (as confirmed by ) concerning management of this item. See relevant guidance at : * Delamanid: Procurement of this item is subject to compliance with recommendations (as confirmed by ) concerning management of this item. See relevant guidance at: * Clofazimine : Procurement of this item is subject to receipt by GDF of named prescriptions from practitioners authorized to prescribe the medicine for this indication and signed Disclaimer for the use of this product 0x1 ; x End of or products list List of T drugs classified according to the GF Q Policy 19/22

20 Edition: Version 95-18th December 2018 List Of Tuberculosis Pharmaceutical Products classified according to the Global Fund Quality ssurance Policy List of ERP ( Expert Review Panel) Reviewed Products which are permitted for time limited procurement: If there is no or only one or 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 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. Ref.N o International Nonproprietary name Strength/ Dose Dosage form Supplier/ Manufacturer(s) Global Fund Q Period Validity for ERP Review Clofazimine * 50mg Macleods Pharmaceutical ERP reviewed Macleods Pharmaceuticals Limited, t, Oxalis Labs Village Theda, P.O Lodhimajra, addi, Distt. Solan, Himachal Pradesh, 1741 l/pvc/pvd C blister or l/l strip pack 28x s or x s Edition: Version 95,18th December 2018 List of T drugs classified according to the GF Q Policy 20/22

21 Ref.N o International Nonproprietary name Strength/ Dose Dosage form Supplier/ Manufacturer(s) Global Fund Q Period Validity for ERP Review Clofazimine * 0mg Macleods Pharmaceutical ERP reviewed Macleods Pharmaceuticals Limited, t, Oxalis Labs Village Theda, P.O Lodhimajra, addi, Distt. Solan, Himachal Pradesh, 1741 l/pvc/pvd C blister or l/l strip pack 28x s or 8x6 s Kanamycin 500mg/2ml solution for Livzon, China ERP reviewed Pharmaceutical Factory No. 38 Chuangye Road North, Jinwan district, Zhuhai, Guangdonglock: Production Line: P08 small volume workshop for production uilding number: P08 Zip: China 3ml Glass ampoule Kanamycin /3ml solution for Livzon, China ERP reviewed Pharmaceutical Factory No. 38 Chuangye Road North, Jinwan district, Zhuhai, Guangdonglock: Production Line: P08 small volume workshop for production uilding number: P08 Zip: China 3ml Glass ampoule Ethionamide 125 mg disp Micro Labs ERP reviewed (Unit-03) 92, Sipcot Industrial Complex, Hosur , Tamilnadu lu/lu strips; lu- PVC/PE/P VdC blisters x 3, x; x3, x, 14x Edition: Version 95,18th December 2018 List of T drugs classified according to the GF Q Policy 21/22

22 Ref.N o International Nonproprietary name Strength/ Dose Dosage form Supplier/ Manufacturer(s) Global Fund Q Period Validity for ERP Review Levofloxacin 0mg disp Micro Labs ERP reviewed Levofloxacin 750mg Micro Labs ERP reviewed (Unit-03) 92, Sipcot Industrial Complex, Hosur , Tamilnadu (Unit-03) 92, Sipcot Industrial Complex, Hosur , Tamilnadu lu/lu strips; lu- PVC/PE/P VdC blisters Container pack X ; x2 0 x Rifampin+Isoniazid 75mg+50 mg disp FDC Lupin ERP reviewed /1, MIDC rea, Chikalthana, urangabad,urangabad lu-lu Strip; lu-lu x1; 5x1 End of ERP Reviewed products list Edition: Version 95,18th December 2018 List of T drugs classified according to the GF Q Policy 22/22