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

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1 List Of Tuberculosis Pharmaceutical Products classified according to the Global Fund Quality ssurance Policy Edition: Version 88-06th of pril 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. Edition: Version 88, 06th of pril 2018 List of T drugs classified according to the GF Q Policy 1/21

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 mg "Pharma Company " - "Pharmaville" Country 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. Edition: Version 88, 06th of pril 2018 List of T drugs classified according to the GF Q Policy 2/21

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 mikacin ( as sulfate) 500 mg/2ml Injection for IM/IV use Pharmatex, Italy Fisio Pharma Palomonte Italy Glass Vial x 2ml mikacin 500 mg/2ml Injection, for IM/IV use Medochemie Limassol Cyprus Glass vial, ampoules Pack of, 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 2 moxycillin + Clavulanic acid 250mg : 62.5mg/ 5ml oral susp Glaxo SmithKline. Middlesex UK ottle ml moxycillin + Clavulanic acid 250mg mg/ 5ml oral susp rown & urk UK Micro Labs, Veersandhra, nekal, angalore ml moxycillin + Clavulanic acid 250mg mg/ 5ml oral susp Medreich UK Medreich Virgonagar angalore Glass bottle ml with measure cup 3 moxycillin + Clavulanic acid 125mg mg/ 5ml oral susp Glaxo SmithKline. Middlesex UK ottle ml Edition: Version 88, 06th of pril 2018 List of T drugs classified according to the GF Q Policy 3/21

4 Global Fund Q SR moxycillin + Clavulanic acid 125mg mg/ 5ml oral susp rown & urk UK Micro Labs, Veersandhra, nekal, angalore ml moxycillin + Clavulanic acid 125mg mg/ 5ml oral susp Medochemie, Limassol (Cyprus) No Medochemie, Limassol Cyprus ml 4 moxycillin + Clavulanic acid 250mg+125mg rown & urk UK Micro Labs, Veersandhra, nekal, angalore 8,, 14, 16, 21 moxycillin + Clavulanic acid 250mg+125mg Remedica Limassol Cyprus lu/ lu (2x s in carton box) 5 moxycillin + Clavulanic acid 500mg + 125mg Remedica Limassol Cyprus lu/ lu (2x s in carton box) moxycillin + Clavulanic acid 500mg+125mg rown & urk UK Micro Labs, Veersandhra, nekal, angalore 8,, 14, 16, 21, 50 & s moxycillin + Clavulanic acid 500mg+125mg Medochemie Limassol Cyprus l/pvc 16, 20, moxycillin + Clavulanic acid 500mg+125mg Reig Jofre Toledo Spain ottle 6, 12(2*6), 24(4*6) 500 moxycillin + Clavulanic acid 500mg+125mg Glaxo SmithKline. Middlesex, Worthing UK 14 moxycillin (as trihydrate)+ Clavulanic acid (as potassium) 500mg+125mg potex Inc Toronto Canada ottle 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, Veersandhra, nekal, angalore 2x7, 3x7, 5x5, Edition: Version 88, 06th of pril 2018 List of T drugs classified according to the GF Q Policy 4/21

5 Global Fund Q SR moxycillin + Clavulanic acid 875mg+125mg Medreich UK Medreich Virgonagar, angalore PVC/lu blister 2x8(16) 7 edaquiline Fumarate * mg (ase) Janssen Cilag, elgium Recipharm Pharmaservices private ottle Capreomycin powder for korn korn, Illinois US Glass vial 1, 1* Capreomycin powder for King Pharmaceuticals Limited Vianex S.. - Plant C', 16th km Marathonos ve., Pallini, ttiki, Greece Glass vial 1 Capreomycin powder for for IM use Vianex Vianex S.. - Plant C', 16th km Marathonos ve., Pallini, ttiki, Greece Glass vial 1 Capreomycin powder for Hisun Pharmaceutical (Hangzhou) Co Fuyang, Hangzhou City, Zhejiang Province China Glass vial 1 Capreomycin powder for spen Pharmacare Korsten, Port Elizabeth South frica Glass vial 1 Capreomycin Capreomycin, Mumbai () NCPC International Corp., China (People's Republic of) T 211 T316 Macleods Pharmaceutical, Kachigam, Daman North China Pharmaceutical Co, New Preparation ranch Factory, No. 115 Hainan Road, Shijiazhuang Economic & Technological Development Zone, Glass vial 1 China Glass vial vialx Edition: Version 88, 06th of pril 2018 List of T drugs classified according to the GF Q Policy 5/21

6 Capreomycin (sulfate) 9 Clarithromycin 250mg Global Fund Q SR Mylan Laboratories T329 Mylan Laboratories Limited [HSF], Plot No. 14, Sipcot II, Krishnagiri Road, Hosur, Type 1 glass vial x1 Remedica Limassol Cyprus lu/pvc Clarithromycin 250mg Medochemie Limassol Cyprus 14 7 (2*7 s in carton box) Clarithromycin 250mg Micro Labs Hosur, Tamilnadu PVC/PVdC lu 6,7,8,,12,14,16,20,500 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 Clarithromycin 500mg Strandhaven UK Essex UK 14 6,, 12,14, 15, 16, 20, 24 7 (2*7 s in carton box) Clarithromycin 500mg Micro Labs Hosur, Tamilnadu lu/pvc 6,7,8,,12,14,16,20,500 Clarithromycin 500mg Clarithromycin 500mg HEC Pharm GmbH, Sunshine Lake Pharma Co.,. Clarithromycin 500mg Mylan Laboratories Sunshine Lake Pharma Co.,. DongGuan, GuangDong Province Waluj, urangabad, Maharashtra China China PVC/PVDC/lu strip, 14, 16, 20, 42, Clofazimine * 50mg Capsule Novartis, Switzerland Sandoz, Kalwe ottle Clofazimine * mg Capsule Novartis, Switzerland Sandoz, Kalwe ottle Edition: Version 88, 06th of pril 2018 List of T drugs classified according to the GF Q Policy 6/21

7 Global Fund Q SR 12 Cycloserine 250 mg Capsule Kachigam, Daman Solan Himachal Pradesh l Strip Cycloserine 250 mg Capsule Dong- Pharmaceutical Co Cycloserine 250 mg Capsule Chao Centre Dong- Pharmaceutical Co Cheonan, Chungcheongnamdo Chao Centre na Republic of Korea lu/lu strip US ottle 40 Cycloserine 250 mg Capsule iocom JSC Stavropol Russia ottle 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 Cycloserine 250 mg Capsule Mylan Laboratories T304 Plot No H-12 & H13 MIDC Waluj Industrial rea, urangabad, Maharashtra, ottle ; lu/lu x1; x1 13 Delamanid * 50mg Otsuka Novel Products GmbH, ndersonrecon (UK). 14 Ethambutol mg Labatec Pharma Meyrin, Geneva Ethambutol mg (Former FTOL-(RIEMSER) rzneimittel) Ethambutol 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) * 50,, 500 x, 24 x 28; bottle Edition: Version 88, 06th of pril 2018 List of T drugs classified according to the GF Q Policy 7/21

8 15 Ethambutol 250 mg 16 Ethambutol 400 mg (Former FTOL-(RIEMSER) rzneimittel) Cadila Pharmaceuticals Global Fund Q SR Dholka, hmedabad, PVC/lu blister, 500 lu/pvc/pvdc ;, 28; Ethambutol 400 mg Kachigam, Daman ; ottle, 28; Ethambutol 400 mg OlainFarm JSC Olaine Latvia ottle Chikalthana, PVC/PVDC/lu 28,; urangabad blister ; Ethambutol 400 mg Lupin ari, 500, rahmana, Jammu s (J & K) Ethambutol 400 mg Labatec Pharma Meyrin, Geneva Ethambutol 400 mg Svizera Europe V Svizera Labs Pvt, Plot No D16/6 TTC Industrial rea, MIDI, Turbhe, Navi Mumbai, Switzerlan d PVC/lu * ottle ; 28x24, Ethambutol 400 mg (Former FTOL-(RIEMSER) rzneimittel) PVC/lu blister, 500 Ethambutol 400 mg S.C. ntibiotice S. Lasi Romania lupvc 17 Ethambutol 500 mg 18 Ethambutol + Isoniazid 400 mg mg Ethambutol + Isoniazid 400 mg mg 19 Ethambutol + Isoniazid + Rifampicin Ethambutol + Isoniazid +Rifampicin 275 mg+75 mg+150 mg 275mg +75mg +150mg s (Former FTOL-(RIEMSER) rzneimittel) Cadila Pharmaceuticals Kachigam, Daman Dholka, hmedabad, Kachigam, Daman; Oxalis lab, Solan, addi Lupin urangabad 2x 150x PVC/lu blister, 500 lu/pvc/pvdc ; PVC/PVdcV/ lu blister container; lu/pvc/pvdc ottle lu/pvc/pvdc blister, 28;, 28 ;, Edition: Version 88, 06th of pril 2018 List of T drugs classified according to the GF Q Policy 8/21

9 Global Fund Q SR 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 275 mg + 75 mg mg mg Lupin Chikalthana urangabad ; 4, 28;672, 500, Ethambutol + Isoniazid + Pyrazinamide + Rifampicin 275 mg + 75 mg mg mg Sandoz Pty Strides rcolab, angalore; Sandoz, Kalwe, Navi Mumbai; Sandoz, Kolshet, Thane; ; ottle PVC/PE/PVd C/lu blister 30, 60, 120, 240, 672, ; Polypropylen e containers 500,; 500 Ethambutol + Isoniazid + Pyrazinamide + Rifampicin Ethambutol Hydrochloride+ Isoniazid + Pyrazinamide + Rifampicin 275 mg + 75 mg mg mg 275 mg + 75 mg mg mg Micro Labs T223 Kachigam, Daman; Oxalis lab, Solan, addi Kumbalgodu, angalore, Karnataka, container; lu/pvc/pvdc lu/lu strip ottle 500, ;, 28, 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, Mumbai () T314 Kachigam, Daman lu/lu strip Ethionamide 125 mg Dispersible, Mumbai () 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 x1; ;x14 Edition: Version 88, 06th of pril 2018 List of T drugs classified according to the GF Q Policy 9/21

10 21 Ethionamide 250 mg Ethionamide 250mg Global Fund Q SR Kachigam, Daman Oxalis lab, Solan, addi Cipla Patalganga Ethionamide 250mg Lupin urangabad Ethionamide 250mg Micro Labs Hosur, Tamilnadu ; Strip ottle; lu/pvc/pvdc lsiter ottle ; L/L Strip ottle ; PVDC/PVC/L Strip ; ; ; 5x ; 22 Imipenum+Cilastatin 250mg/250mg solution for infusion Fresenius Kabi Runcorn, Cheshire UK Glass vial x 20ml 23 Imipenum+Cilastatin 500mg/500mg Injection Labatec Pharma nfarm Facta Farmaceutici CS Dobfar Greece Italy Italy Glass vials in carton box Imipenum+Cilastatin 500mg/500mg Injection DEMO S Pharmaceutical Industry ttiki Greece Glass vial in carton box 1;;50 Imipenum+Cilastatin 500mg/500mg solution for infusion Fresenius Kabi Runcorn, Cheshire UK Glass vial x 20ml Imipenum+Cilastatin Imipenum+Cilastatin Panpharma 500mg/500mg 500mg/500mg solution for infusion solution for infusion Sun Pharmaceutical Industries 24 Isoniazid 50 mg (Former FTOL-(RIEMSER) rzneimittel) 25 Isoniazid mg PNMEDIC, France Isoniazid mg (Former FTOL-(RIEMSER) rzneimittel) Madhya Pradesh Glass vial x 30ml FCT FRMCEUTICI S.p. Kachigam, Daman Oxalis lab, Solan, addi Isonazid mg Micro Labs Hosur, Tamilnadu Isonazid mg Lupin Chikalthana, urangabad, Isonazid mg 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 PVC/lu ottle, 500 ;, 28, 500 * (), * Edition: Version 88, 06th of pril 2018 List of T drugs classified according to the GF Q Policy /21

11 Global Fund Q SR Isonazid mg S.C. ntibiotice S. Lasi Romania lupvc 26 Isoniazid 200 mg (Former FTOL-(RIEMSER) rzneimittel) 27 Isoniazid 300 mg Kachigam, Daman Oxalis lab, Solan, addi Isoniazid 300 mg Micro Labs Hosur, Tamilnadu PVC/clar/PVC /lu blister Container ; PVC/PVdC/lu Container Isonazid 300mg S.C. ntibiotice S. Lasi Romania lupvc 2x 150x, 500 ;, 28 3x 150x Isonazid 300mg Cadila Pharmaceuticals Dholka, hmedabad PVC-PVDC/lu blister ;,24x28 500, 28 Isoniazid + Rifampicin 30mg+ 60mg Isoniazid + Rifampicin 30mg+ 60mg 29 Isoniazid + Rifampicin 60mg + 60mg Dispersible DispersibleT ablet Dispersible Lupin Kachigam, Daman Chikalthana, urangabad; ari rahmana, Jammu (J&K) Kachigam, Daman container; lu/pvc/pvdc ;, 28 l/l strip 15x6; 14x6 container; lu/pvc/pvdc ;, Isoniazid + Rifampicin 75 mg mg Lupin Chikalthana urangabad ; 15;, 500, Isoniazid + Rifampicin 75 mg mg Sandoz Pty Isoniazid + Rifampicin 75 mg mg Strides rcolab, angalore; Sandoz, Kalwe, Navi Mumbai; Sandoz, Kolshet, Thane Kachigam, Daman; Oxalis lab, Solan, addi ; ottle; lu/pvc/pvdc 30, 60, 120, 240, 28,672, ; 500, ; 500, ;, 28 Edition: Version 88, 06th of pril 2018 List of T drugs classified according to the GF Q Policy 11/21

12 Global Fund Q SR 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 (Former FTOL-(RIEMSER) rzneimittel) PVC/lu blister, 500 Isoniazid + Rifampicin 150 mg mg Capsule S.C. ntibiotice S. Lasi Romania lupvc Isoniazid + Rifampicin 150 mg mg 33 Isoniazid + Pyrazinamide+Rifampicin 30 mg+ 150 mg+60mg Dispersible T231 Kachigam, Daman Kachigam, Daman ottle; PVC/PVDC/ lu blister container; lu/pvc/pvdc 1x x,500;, 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, 34 Kanamycin Kanamycin (sulfate) Kanamycin (sulfate) 500mg powder for powder for powder for Panpharma Laboratory Fougeres France Glass vial 50 T213 T212 Unit 2, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam, Daman, Unit 2, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam, Daman, Glass vial ml 1 Glass vial ml 1 Edition: Version 88, 06th of pril 2018 List of T drugs classified according to the GF Q Policy 12/21

13 35 Kanamycin /4ml Levofloxacin mg solution for - Route of administratio n:im Dispersible Global Fund Q SR 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 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, lu/pvc 3*1, 5*1, 7*1, *1,14*1, 50*1, 200*1 Levofloxacin 250mg Micro Labs Hosur, Tamilnadu PVC/lu blister Levofloxacin 250mg Denk Pharma GmbH & Co Rottendorf Pharma GmbH, Ennigerloh, 3, 5, 7, Levofloxacin 250mg potex Inc potex Inc Toronto Canada ottle 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 () lu/pvc blister 5's x 20 PVC/PVDC/L U- ottle; lu/pvc Levofloxacin 500mg Micro Labs Hosur, Tamilnadu PVC/lu blister 6's 50; 1* Edition: Version 88, 06th of pril 2018 List of T drugs classified according to the GF Q Policy 13/21

14 Global Fund Q SR Levofloxacin 500mg Denk Pharma GmbH & Co Rottendorf Pharma GmbH, Ennigerloh 5, 7, Levofloxacin 500mg potex Inc potex Inc Toronto Canada ottle Levofloxacin 500mg Medochemie Limassol Cyprus 3,5,7, ox (8x) Levofloxacin 500mg Solan, Himachal Pradesh, lu/pvc blister 5's x 20 Levofloxacin HEC Pharm 500mg HEC Pharm GmbH, Sunshine Lake Pharma Co.,. China PVC/PVDC/L U- 's Levofloxacin 500mg Hetero Labs Hetero Labs Limited UNIT- V, TSIIC Formulation SEZ, Sy No. 439, 440, 441 & 458, Polepally Village, Jadcherla Mandal, Mahaboobnagar District, lu/pvc 1*1, 5*1, 7*1, *1,14*1, 50*1, 500*1 38 Levofloxacin 750mg potex Inc potex Inc Toronto Canada ottle Levofloxacin 750mg Solan, Himachal Pradesh, lu/pvc blister 's x Levofloxacin 750mg Hetero Labs, Hetero Unit V ndra Pradesh 5, 39 Linezolid 600mg Hetero Europe SL Spain Hetero Unit V ndra Pradesh 5, Linezolid 600mg Pharmacia UK Pfizer, Puurs, elgium ottle 1x, 2x, 3x, 5x, 6x 30,60 Edition: Version 88, 06th of pril 2018 List of T drugs classified according to the GF Q Policy 14/21

15 Global Fund Q SR Linezolid 600mg Teva Pharma S.L.U, Zaragoza, Spain Teva Pharmaceutical Works, Debrecen 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 Linezolid 600mg 40 Linezolid mg/5 ml 41 Linezolid 2mg/ml 42 Meropenem Meropenem Granules for Oral Suspension Intra Venous Infusion Intra Venous /Inf Intra Venous Dr.Reddy s Laboratories (UK) Limited s T297 Mahaboob Nagar District, ndhra ulk Pradesh Production Polpharma S. ul.pelplinska 19, Starogard Gdanski, Poland lock No. N2, Village Theda, P.O. Lodhi Majra, Tehsil addi, District Solan, Himachal Pradesh, Poland ottle op/l/pvc/l blister lu/pvc Strip lu/lu Pharmacia UK Pfizer, Puurs, elgium Glass bottle Pharmacia UK Vianex, Greece PNMEDIC, France Fresenius Kabi Norge S Vianex Plant D Patra, xaia FacT FRMCEUTICI S.p., Teramo Norway Greece Italy Infusion bag Glass vial Glass vial 20 s & s units per pack in ; 20; 30; 50; 60; ;, 4x5 5x240ml (66 g per bottle) x240ml (66 g per bottle) 5x300ml x300ml 20x 300ml 1 vial 1x vials 1 vial 1x vials Meropenem Intra Venous DEMO S Pharmaceutical Industry Greece DEMO S Pharmaceutical Industry 43 Moxifloxacin ( as hydrochloride) 400 mg Cipla Patalganga Greece Glass vial ottle; 1 vial 1x vials 30,, ; 5 Moxifloxacin 400mg ayer Schering G ayer Schering G Leverkusen 5 Edition: Version 88, 06th of pril 2018 List of T drugs classified according to the GF Q Policy 15/21

16 Moxifloxacin 400mg Moxifloxacin 400mg Sun Pharmaceutical Industries Global Fund Q SR Kachigam, Damam; Solan, addi MSN Laboratories, Medak District, ndhra Pradesh, lu/lu cold form blister lu/lu strip lu/pvc/pvdc blister 5,, 20 1 x 5, 1 x Moxifloxacin 400mg Hetero Europe SL Hetero Unit V ndra Pradesh 5,7, Moxifloxacin ( as hydrochloride) 400 mg Mylan Laboratories Limited T286 Sinnar, Nashik, Maharashtra, lu/pvc/pvdc blister ottle Moxifloxacin ( as hydrochloride) 400 mg Micro Labs, T263 Hosur, Tamilnadu PVC/PE/PVDC /lu blister; lu/lu blister; ; x ; 30, 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 44 Ofloxacin 200mg Cipla Patalganga ottle; lu/pvc, 500, ; 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 ottle; PV/lu PVC/lu blister PVC/lu blister ottle; lu/pvc ottle; PV/lu,500,, 500, ; Edition: Version 88, 06th of pril 2018 List of T drugs classified according to the GF Q Policy 16/21

17 Global Fund Q SR 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 PVC/lu blister container; Sachet,500, OlainFarm JSC - Olaine Latvia ox 25, 300 g; 9.2g Para-minoSalicylic cid 4g Granules Jacobus New Jersey US ox Prothionamide 250mg OlainFarm JSC Olaine Latvia Prothionamide 250mg (Former FTOL-(RIEMSER) rzneimittel) Schiffweiler PVC/L blister 50, Prothionamide 250mg Micro Labs Hosur ; 14; ottle Prothionamide 250mg Lupin Chikalthana, urangabad Pyrazinamide 150mg Dispersible s T307 Solan, Himachal Pradesh triple laminated bag further packed in 50 Pyrazinamide 400 mg Cadila Pharmaceuticals Dholka, hmedabad ;, 28; Pyrazinamide 400 mg Kachigam,Daman Oxalis lab, Solan, addi ottle; lu/pvc/pvdc ;,28 Pyrazinamide 400 mg Micro Labs Hosur, Tamilnadu 51 Pyrazinamide 500 mg Micro Labs Hosur, Tamilnadu Pyrazinamide 500 mg (Former FTOL-(RIEMSER) rzneimittel) container container lu/pvc/pvdc PVC/lu blister, 500 Pyrazinamide 500 mg OlainFarm JSC Olaine Lativia ottle Pyrazinamide 500 mg Labatec Pharma Meyrin, Geneva Pyrazinamide 500 mg Kachigam Damam Oxalis lab, Solan, addi Switzerlan d lu/pvc blister 3 x, x, 3 x 28, 24 x 28; Edition: Version 88, 06th of pril 2018 List of T drugs classified according to the GF Q Policy 17/21

18 Global Fund Q SR Pyrazinamide 500 mg S.C. ntibiotice S. Lasi Romania lupvc 52 Rifabutin 150mg Capsule Lupin - Chikalthana, urangabad 2x 150x ottle 53 Rifapentine 150mg Sanofi ventis, US - T366 Sanofi Sp, nagni Italy 24 (3 x 8's) 54 Rifampicin mg/5ml Rifampicin mg / 5 ml Granule for Syrup Granulate for oral suspension vantis Pharma (Former FTOL-(RIEMSER) rzneimittel) Gruppo Lepanti, nagni Lomapharm, 55 Rifampicin 150 mg Capsule Labatec Pharma Meyrin, Geneva Italy Glass ottle; 120ml Glass bottle ml Switzerlan d PVC/lu *8's Rifampicin 150 mg Capsule vantis Pharma Gruppo Lepanti, nagni Italy Glass ottle; ; Rifampicin 150 mg (Former FTOL-(RIEMSER) rzneimittel) PVC/clar/PVC /lu blister Rifampicin 150 mg Capsule Remedica Limassol Cyprus lu/pvc blister Rifampicin 150 mg Capsule S.C. ntibiotice S. Lasi Romania lupvc, 500 (* caps in carton box) 2x x Rifampicin 150 mg Capsule T259 Kachigam, Daman ottle; lu/lu strip ; * 56 Rifampicin 300 mg Capsule Labatec Pharma Meyrin, Geneva Rifampicin 300 mg Capsule vantis Pharma Rifampicin 300 mg (Former FTOL-(RIEMSER) rzneimittel) Gruppo Lepanti, nagni Switzerlan d Italy PVC/lu Glass ottle; PVC/clar/PVC /lu blister *4's ;, 500 Rifampicin 300 mg Capsule S.C. ntibiotice S. Lasi Romania lupvc 1x x Rifampicin 300 mg Capsule Remedica Limassol Cyprus lu/pvc blister (* caps in carton box) Edition: Version 88, 06th of pril 2018 List of T drugs classified according to the GF Q Policy 18/21

19 Global Fund Q SR 57 Rifampicin 450 mg Capsule vantis Pharma Gruppo Lepanti, nagni Italy Glass ottle; 30; 8 Rifampicin 450 mg (Former FTOL-(RIEMSER) rzneimittel) PVC/clar/PVC /lu blister, Rifampicin 600 mg (Former FTOL-(RIEMSER) rzneimittel) PVC/clar/PVC /lu blister, 500 Rifampicin+Isoniazid 75mg + 50mg Disp Macleods T302 Phase II, Unit II, Plot No , Premier Ind. Estate, Kachigam, Daman (U.T). Oxalis Labs, Vill. Theda, P.O. container pack lu/lu strip pack (), Streptomycin Panpharma Laboratory Fougeres France ottle 50 Streptomycin -IM Reig Jofre Laboratorio Reig Jofré, S.. Madrid. raun Medical, S.. Jaén Spain Glass Vial Streptomycin 1 g (Former FTOL-(RIEMSER) rzneimittel) Panpharma, Fougeres France ottle 1, Edition: Version 88, 06th of pril 2018 List of T drugs classified according to the GF Q Policy 19/21

20 Streptomycin (sulfate) sterile 1 g Global Fund Q SR NCPC International Corp. T296 North China Pharmaceutical Co, New Preparation ranch Factory, No. 115 Hainan Road, Shijiazhuang, Hebei China (People's Republic of) Vial, Type III glass 1x 60 Terizidone 250mg Capsule (Former FTOL-(RIEMSER) rzneimittel) Schiffweiler 50 Terizidone 250mg Capsule s T303 Macleods Pharmaceuticals, Unit 2, Plot No 25-27, Survey No 366, Premier Industrial Estate, Container, Strip, lu/lu x1 * 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 End of or products list Edition: Version 88, 06th of pril 2018 List of T drugs classified according to the GF Q Policy 20/21

21 Edition: Version 88-06th of pril 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 Ethambutol mg disp Macleods ERP reviewed Unit II, Plot No Sr. No. 366, Kachigam, Daman pack lu/lu strip pack 6x Cycloserine USP 125mg capsule Macleods ERP reviewed Capreomycin USP 0.5g Injection Macleods ERP reviewed Moxifloxacin mg disp Macleods ERP reviewed End of ERP Reviewed products list Phase II, Unit II, Plot No Sr. No. 366, Premier Ind. Estate, Kachigam, Daman Macleods Pharmaceuticals Phase I, Unit II, Plot No Sr. No. 366, Kachigam, Daman Macleods Pharmaceuticals Phase I, Unit II, Plot No Sr. No. 366, Kachigam, Daman pack strip pack Glass vial ml pack Edition: Version 88, 06th of pril 2018 List of T drugs classified according to the GF Q Policy 21/21

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