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

List Of Tuberculosis Pharmaceutical Products classified according to the Global Fund Quality ssurance Policy Edition: Version 89-16th of May 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: http://www.theglobalfund.org/en/about/procurement/list/ 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

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 tablets while within liquids, oral solution and suspension are grouped together.similarly, the entero coated tablet or dispersible tablet will not share the same reference number as non entero coated or dispersible tablets. 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 60 16 17 0mg "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. tablet 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

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, 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 250mg : 62.5mg/ 5ml oral susp Glaxo SmithKline. Middlesex UK ottle 0ml moxycillin + Clavulanic acid 250mg + 62.5mg/ 5ml oral susp rown & urk UK Micro Labs, Veersandhra, nekal, angalore 0ml List of T drugs classified according to the GF Q Policy 3/22

moxycillin + Clavulanic acid 250mg + 62.5mg/ 5ml oral susp Global Fund Q SR Medreich UK Medreich Virgonagar angalore Glass bottle 0ml with measure cup 3 moxycillin + Clavulanic acid 125mg + 31.25mg/ 5ml oral susp Glaxo SmithKline. Middlesex UK ottle 0ml moxycillin + Clavulanic acid 125mg + 31.25mg/ 5ml oral susp rown & urk UK Micro Labs, Veersandhra, nekal, angalore 0ml moxycillin + Clavulanic acid 125mg + 31.25mg/ 5ml oral susp Medochemie, Limassol (Cyprus) No Medochemie, Limassol Cyprus 0ml 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 tablets in carton box) 5 moxycillin + Clavulanic acid 500mg + 125mg moxycillin + Clavulanic acid 500mg+125mg rown & urk UK Remedica Limassol Cyprus lu/ lu Micro Labs, Veersandhra, nekal, angalore (2x tablets 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 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 0 6 moxycillin + Clavulanic acid 875mg + 125mg Medochemie Limassol Cyprus l/pvc 14 6, 12(2*6), moxycillin + Clavulanic acid 875mg + 125mg Reig Jofre Toledo Spain 24(4*6) ottle 500 moxycillin + Clavulanic acid 875mg + 125mg Glaxo SmithKline. Middlesex UK 14 List of T drugs classified according to the GF Q Policy 4/22

Global Fund Q SR moxycillin + Clavulanic acid 875mg+125mg rown & urk UK Micro Labs, Veersandhra, nekal, angalore 2x7, 3x7, 5x5, moxycillin + Clavulanic acid 875mg+125mg Medreich UK Medreich Virgonagar, angalore PVC/lu blister 2x8(16) 7 edaquiline Fumarate * 0mg (ase) Janssen Cilag, elgium Recipharm Pharmaservices private ottle 188 24 8 Capreomycin 1g powder for korn korn, Illinois US Glass vial 1, 1* Capreomycin 1g powder for King Pharmaceuticals Limited Vianex S.. - Plant C', 16th km Marathonos ve., Pallini, ttiki, Greece Glass vial 1 Capreomycin 1g powder for for IM use Vianex Vianex S.. - Plant C', 16th km Marathonos ve., Pallini, ttiki, Greece Glass vial 1 Capreomycin 1g powder for Hisun Pharmaceutical (Hangzhou) Co Fuyang, Hangzhou City, Zhejiang Province China Glass vial 1 Capreomycin 1g powder for spen Pharmacare Korsten, Port Elizabeth South frica Glass vial 1 Capreomycin 1g, Mumbai () T 211 Macleods Pharmaceutical, Kachigam, Daman Glass vial 1 List of T drugs classified according to the GF Q Policy 5/22

Capreomycin Capreomycin (sulfate) 1g 1g NCPC International Corp., China (People's Republic of) Global Fund Q SR T316 Mylan Laboratories T329 North China Pharmaceutical Co, New Preparation ranch Factory, No. 115 Hainan Mylan Laboratories Limited [HSF], Plot No. 14, Sipcot II, Krishnagiri Road, Hosur, 635 9 China Glass vial 1g vialx Type 1 glass vial 1gx1 9 Clarithromycin 250mg Remedica Limassol Cyprus lu/pvc 7 (2*7 tablets in carton box) Clarithromycin 250mg Medochemie Limassol Cyprus 14 Clarithromycin 250mg Micro Labs Hosur, Tamilnadu PVC/PVdC lu 6,7,8,,12,14,16,20 0,500 Clarithromycin 250mg HEC Pharm GmbH, Sunshine Lake Pharma Co.,. China DongGuan, Sunshine Lake Pharma PVC/PVDC/lu 6,, 12,14, Clarithromycin 250mg GuangDong China Co.,. strip 15, 16, 20, 24 Province 7 (2*7 tablets Clarithromycin 500mg Remedica Limassol Cyprus lu/pvc in carton box) Clarithromycin 500mg Medochemie Limassol Cyprus 14 Clarithromycin 500mg Strandhaven UK Essex UK 14 Clarithromycin 500mg Micro Labs Hosur, Tamilnadu lu/pvc 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 6,7,8,,12,14,16,20 0,500 China China PVC/PVDC/lu strip, 14, 16, 20, 42, 0 60 List of T drugs classified according to the GF Q Policy 6/22

Global Fund Q SR 11 Clofazimine * 50mg Capsule Novartis, Switzerland Sandoz, Kalwe ottle 0 Clofazimine * 0mg Capsule Novartis, Switzerland Sandoz, Kalwe ottle 0 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, Chao Centre na Republic of Korea lu/lu strip 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, 605 014 ottle lu/lu 40x1 Cycloserine 250 mg Capsule Mylan Laboratories T304 13 Delamanid * 50mg Otsuka Novel Products GmbH, Plot No H-12 & H13 MIDC Waluj Industrial rea, urangabad, Maharashtra, 431 136 ndersonrecon (UK). UK ottle ; lu/lu ottle lu/lu strip 0x1; x1 50, 300 5x8tab(40) 6x8 tab(48) List of T drugs classified according to the GF Q Policy 7/22

Global Fund Q SR 14 Ethambutol 0 mg Labatec Pharma Meyrin, Geneva Switzerlan d PVC/lu ottle * 0 Ethambutol 0 mg SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) Ethambutol 0 mg 15 Ethambutol 250 mg tablet 16 Ethambutol 400 mg SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) Cadila Pharmaceuticals Kachigam Damam Dholka, hmedabad, PVC/clar/PVC /lu blister l/pvc/pvdc blister 50, 0, 500 x, 24 x 28; bottle PVC/lu blister 0, 500 lu/pvc/pvdc ;, 28; Ethambutol 400 mg ;, 28; Kachigam, Daman ottle Ethambutol 400 mg OlainFarm JSC Olaine Chikalthana, Latvia ottle PVC/PVDC/lu 28,; Ethambutol 400 mg Lupin urangabad ari blister ; 0, 500, Ethambutol 400 mg Labatec Pharma Meyrin, Geneva Switzerlan d PVC/lu * Ethambutol 400 mg Svizera Europe V Ethambutol 400 mg tablet SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) Svizera Labs Pvt, Plot No D16/6 TTC Industrial ottle ; 28x24, 0 PVC/lu blister 0, 500 Ethambutol 400 mg S.C. ntibiotice S. Lasi Romania lupvc 17 Ethambutol 500 mg tablet 18 Ethambutol + Isoniazid 400 mg + 150 mg Ethambutol + Isoniazid 400 mg + 150 mg 19 Ethambutol + Isoniazid + Rifampicin Ethambutol + Isoniazid +Rifampicin 275 mg+75 mg+150 mg 275mg +75mg +150mg s SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) Cadila Pharmaceuticals Kachigam, Daman Dholka, hmedabad, Kachigam, Daman; Oxalis lab, Solan, addi Lupin urangabad 2x 150x PVC/lu blister 0, 500 lu/pvc/pvdc ; PVC/PVdcV/ lu blister container; lu/pvc/pvdc ottle lu/pvc/pvdc blister, 28;, 28 ;, 28 28 List of T drugs classified according to the GF Q Policy 8/22

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, 400 703 ottle ; lu/pvc/pvdc x1; 28x24 20 Ethambutol + Isoniazid + Pyrazinamide + Rifampicin 275 mg + 75 mg + 400 mg + 150 mg Lupin Chikalthana urangabad ; 4, 28;672 0, 500, Ethambutol + Isoniazid + Pyrazinamide + Rifampicin 275 mg + 75 mg + 400 mg + 150 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 + 400 mg + 150 mg 275 mg + 75 mg + 400 mg + 150 mg Micro Labs T223 Kachigam, Daman; Oxalis lab, Solan, addi Kumbalgodu, angalore, Karnataka, container; lu/pvc/pvdc lu/lu strip ottle 500, ;, 28, 24x28 500 Ethambutol Hydrochloride+ Isoniazid + Pyrazinamide + Rifampicin 275 mg + 75 mg + 400 mg + 150 mg Svizera Europe V T193 Svizera Labs Pvt, Plot No D16/6 TTC Industrial rea, MIDI, Turbhe, Navi Mumbai, 400 703 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 List of T drugs classified according to the GF Q Policy 9/22

Global Fund Q SR Ethionamide 125 mg Micro Labs T331 Unit 03, 92 Sipcot Industrial Complex, Hosur, Tamil Nadu ottle lu/pvc- PVdC 0x1; ;x14 21 Ethionamide 250 mg Ethionamide 250mg tablet Kachigam, Daman Oxalis lab, Solan, addi Cipla Patalganga Ethionamide 250mg Lupin urangabad ; Strip ottle; lu/pvc/pvdc lsiter ottle ; L/L Strip 0; 0; 0; 5x Ethionamide 250mg Micro Labs Hosur, Tamilnadu ottle ; PVDC/PVC/L Strip 0; 22 Imipenum+Cilastatin 250mg/250mg 23 Imipenum+Cilastatin 500mg/500mg solution for infusion Injection Fresenius Kabi Runcorn, Cheshire UK Glass vial x 20ml 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 Imipenum+Cilastatin Imipenum+Cilastatin Panpharma 500mg/500mg 500mg/500mg 500mg/500mg solution for infusion solution for infusion solution for infusion 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 Italy Glass vial 20ml 1,, 25 PVC/clar/PVC /lu blister Container; PVC/PVdc PVC/clar/PVC /lu blister 0, 500 ;, 28 0, 500 List of T drugs classified according to the GF Q Policy /22

Global Fund Q SR Isonazid 0mg Micro Labs Hosur, Tamilnadu Isonazid 0mg Lupin Chikalthana, urangabad, Isonazid 0mg Labatec Pharma Meyrin, Geneva Switzerlan d Container l/pvc/pvdc blister PVC/lu ottle Isonazid 0mg S.C. ntibiotice S. Lasi Romania lupvc 26 Isoniazid 200 mg SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) 27 Isoniazid 300 mg Kachigam, Daman Oxalis lab, Solan, addi PVC/clar/PVC /lu blister Container ; PVC/PVdC/lu * (0) 0, * 0 2x 150x 0, 500 ;, 28 Isoniazid 300 mg Micro Labs Hosur, Tamilnadu Container Isonazid 300mg S.C. ntibiotice S. Lasi Romania lupvc Isonazid 300mg Cadila Pharmaceuticals Dholka, hmedabad PVC-PVDC/lu blister ; 3x 150x,24x28 500, 28 Isoniazid + Rifampicin 30mg+ 60mg Isoniazid + Rifampicin 30mg+ 60mg Dispersible DispersibleT ablet Lupin Kachigam, Daman Chikalthana, urangabad; ari rahmana, Jammu (J&K) container; lu/pvc/pvdc ;, 28 l/l strip 15x6; 14x6 29 Isoniazid + Rifampicin 60mg + 60mg Dispersible Kachigam, Daman container; lu/pvc/pvdc ;, 28 30 Isoniazid + Rifampicin 75 mg + 150 mg Lupin Isoniazid + Rifampicin 75 mg + 150 mg Sandoz Pty Chikalthana urangabad Strides rcolab, angalore; Sandoz, Kalwe, Navi Mumbai; Sandoz, Kolshet, Thane ; ; 15; 0, 500, 30, 60, 120, 240, 28,672, ; 500, ; List of T drugs classified according to the GF Q Policy 11/22

Isoniazid + Rifampicin 75 mg + 150 mg Global Fund Q SR Kachigam, Daman; Oxalis lab, Solan, addi ottle; lu/pvc/pvdc 500, ;, 28 Isoniazid + Rifampicin 75 mg + 150 mg Svizera Europe V T189 Svizera Labs Pvt, Plot No D16/6 TTC Industrial rea, MIDI, Turbhe, Navi Mumbai, 400 703 ottle ; lu/pvc/pvdc x1; 28x24 31 Isoniazid+Rifampicin 150mg+150mg Lupin urangabad $ 32 Isoniazid + Rifampicin 150 mg + 300 mg Grouppo Lepetit Isoniazid + Rifampicin Isoniazid + Rifampicin 150 mg + 300 mg 150 mg + 300 mg tablet 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 + 300 mg Capsule S.C. ntibiotice S. Lasi Romania lupvc Isoniazid + Rifampicin 150 mg + 300 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 0x,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, 396 2 Strip lu/lu, ottle, 0 34 Kanamycin 1g Kanamycin (sulfate) 1g 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, 396 2 Glass vial ml 1 List of T drugs classified according to the GF Q Policy 12/22

Global Fund Q SR Kanamycin (sulfate) 500mg powder for T212 Unit 2, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam, Daman, 396 2 Glass vial ml 1 35 Kanamycin 1g/4ml solution for - Route of administratio n:im Meiji Seika Pharma Tokyo Japan Glass ampoule Levofloxacin 0mg Dispersible 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 0 Levofloxacin 250mg Medochemie Limassol Cyprus Levofloxacin 250mg Solan, Himachal Pradesh, 3,5,7, ox () lu/pvc blister 5's x 20 tablet List of T drugs classified according to the GF Q Policy 13/22

Global Fund Q SR Levofloxacin HEC Pharm 250mg HEC Pharm GmbH, Sunshine Lake Pharma Co.,. China PVC/PVDC/L U- 6's 37 Levofloxacin 500mg Cipla Goa ottle; lu/pvc 50; 1* Levofloxacin 500mg Micro Labs Hosur, Tamilnadu PVC/lu blister Levofloxacin 500mg Denk Pharma GmbH & Co Rottendorf Pharma GmbH, Ennigerloh 5, 7, Levofloxacin 500mg potex Inc potex Inc Toronto Canada ottle 0 Levofloxacin 500mg Medochemie Limassol Cyprus 3,5,7, ox (8x) Levofloxacin 500mg Solan, Himachal Pradesh, lu/pvc blister 5's x 20 tablet 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 0 List of T drugs classified according to the GF Q Policy 14/22

Global Fund Q SR Levofloxacin 750mg Solan, Himachal Pradesh, lu/pvc blister 's x tablet 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 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 Linezolid 600mg 40 Linezolid 0 mg/5 ml List of T drugs classified according to the GF Q Policy Granules for Oral Suspension Dr.Reddy s Laboratories (UK) Limited s T297 Mahaboob Nagar District, ndhra Pradesh ulk Production Polpharma S. ul.pelplinska 19, 83-200 Starogard Gdanski, Poland lock No. N2, Village Theda, P.O. Lodhi Majra, Tehsil addi, District Solan, Himachal Pradesh, 174 1 Poland ottle op/l/pvc/l blister lu/pvc Strip lu/lu Pharmacia UK Pfizer, Puurs, elgium Glass bottle 15/22 20 tablets & 0 tablets units per pack in ; 20; 30; 50; 60; 0 ;, 4x5 5x240ml (66 g per bottle) x240ml (66 g per bottle)

41 Linezolid 2mg/ml 42 Meropenem 1g Intra Venous Infusion Intra Venous /Inf usion Global Fund Q SR Pharmacia UK Vianex, Greece Fresenius Kabi Norge S Vianex Plant D Patra, xaia Norway Greece Infusion bag Glass vial 5x300ml x300ml 20x 300ml 1 vial 1x vials Meropenem Meropenem 1g 1g Intra Venous Intra Venous PNMEDIC, France DEMO S Pharmaceutical Industry Greece FacT FRMCEUTICI S.p., Teramo DEMO S Pharmaceutical Industry 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 ayer Schering G Leverkusen Kachigam, Damam; Solan, addi MSN Laboratories, Medak District, ndhra Pradesh, Hetero Unit V ndra Pradesh Italy Greece Glass vial Glass vial ottle; 1 vial 1x vials 1 vial 1x vials 30, 0, ; 5 5 lu/lu cold form blister lu/lu strip lu/pvc/pvdc blister 5,, 20 1 x 5, 1 x 5,7, Moxifloxacin ( as hydrochloride) 400 mg Mylan Laboratories Limited T286 Sinnar, Nashik, Maharashtra, lu/pvc/pvdc blister ottle 0 Moxifloxacin ( as hydrochloride) 400 mg Micro Labs, T263 Hosur, Tamilnadu PVC/PE/PVDC /lu blister; lu/lu blister; ; x ; 30, 0 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, 509 301 lu/lu x1 List of T drugs classified according to the GF Q Policy 16/22

Global Fund Q SR 44 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 Delayed Release Granules Kachigam, Daman Solan, Himachal Pradesh ottle; lu/pvc ottle; PV/lu PVC/lu blister PVC/lu blister ottle; lu/pvc ottle; PV/lu PVC/lu blister container; Sachet 0, 500, ; 0 0 0,500, 0, 500, ; 0 0,500, 0g; 9.2g 47 Para-aminosalicylic cid sodiam 4g oral solution OlainFarm JSC - Olaine Latvia ox 25, 300 Para-minoSalicylic cid 4g Granules Jacobus New Jersey US ox 30 48 Prothionamide 250mg OlainFarm JSC Olaine Latvia Prothionamide 250mg SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) Schiffweiler PVC/L blister 50, 0 Prothionamide 250mg Micro Labs Hosur Prothionamide 250mg Lupin Chikalthana, urangabad ; ottle 14; 0 50 49 Pyrazinamide 150mg Dispersible tablets T307 Solan, Himachal Pradesh triple laminated bag further packed in 0 50 Pyrazinamide 400 mg Cadila Pharmaceuticals Dholka, hmedabad ;, 28; Pyrazinamide 400 mg Kachigam,Daman Oxalis lab, Solan, addi Pyrazinamide 400 mg Micro Labs Hosur, Tamilnadu ottle; lu/pvc/pvdc container ;,28 List of T drugs classified according to the GF Q Policy 17/22

Global Fund Q SR 51 Pyrazinamide 500 mg Micro Labs Hosur, Tamilnadu Pyrazinamide 500 mg tablet SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) container lu/pvc/pvdc PVC/lu blister 0, 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 Pyrazinamide 500 mg S.C. ntibiotice S. Lasi Romania lupvc 52 Rifabutin 150mg Capsule Lupin - Chikalthana, urangabad 3 x, x, 3 x 28, 24 x 28; 2x 150x 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 Italy Glass ottle; 120ml Glass bottle 0ml Switzerlan d PVC/lu *8's Rifampicin 150 mg Capsule vantis Pharma Gruppo Lepanti, nagni Italy Glass ottle; 0; 0 Rifampicin 150 mg tablet SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) PVC/clar/PVC /lu blister Rifampicin 150 mg Capsule Remedica Limassol Cyprus lu/pvc blister 0, 500 (* caps in carton box) Rifampicin 150 mg Capsule S.C. ntibiotice S. Lasi Romania lupvc 2x 0x Rifampicin 150 mg Capsule T259 Kachigam, Daman 56 Rifampicin 300 mg Capsule Labatec Pharma Meyrin, Geneva Rifampicin 300 mg Capsule vantis Pharma Gruppo Lepanti, nagni Switzerlan d Italy ottle; lu/lu strip PVC/lu Glass ottle; 0; * *4's 0; 0 Rifampicin 300 mg tablet SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) PVC/clar/PVC /lu blister 0, 500 List of T drugs classified according to the GF Q Policy 18/22

Global Fund Q SR 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, nagni Italy Glass ottle; 30; 8 Rifampicin 450 mg tablet SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) PVC/clar/PVC /lu blister 0, 500 58 Rifampicin 600 mg tablet SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) PVC/clar/PVC /lu blister 0, 500 Rifampicin+Isoniazid 75mg + 50mg Disp tablet Macleods T302 Phase II, Unit II, Plot No. 25-27, 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 (), 28 59 Streptomycin 1g Panpharma Laboratory Fougeres France ottle 50 Streptomycin 1g -IM Reig Jofre Laboratorio Reig Jofré, S.. Madrid. raun Medical, S.. Jaén Spain Glass Vial 0 List of T drugs classified according to the GF Q Policy 19/22

Global Fund Q SR Streptomycin 1 g SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) Panpharma, Fougeres France ottle 1, Streptomycin (sulfate) sterile 1 g 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 SW Pharma GmbH (Former FTOL-(RIEMSER) rzneimittel) Schiffweiler 50 * Terizidone 250mg Capsule s T303 Macleods Pharmaceuticals, Unit 2, Plot No 25-27, Survey No 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 : http://apps.who.int/iris/bitstream/665/84879/1/9789241505482_eng.pdf?ua=1 * Delamanid: Procurement of this item is subject to compliance with recommendations (as confirmed by ) concerning management of this item. See relevant guidance at: http://apps.who.int/iris/bitstream/665/137334/1/_htm_t_2014.23_eng.pdf?ua=1&ua=1 * 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 End of or products list List of T drugs classified according to the GF Q Policy 20/22

Edition: Version 89-16th of May 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 https://www.theglobalfund.org/media/5863/psm_notification_form_en.doc) 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 0mg disp tablet Macleods ERP reviewed 17-01-2019 Unit II, Plot No. 25-27 Sr. No. 366, Kachigam, Daman pack lu/lu strip pack 6x Cycloserine USP 125mg capsule Macleods ERP reviewed 31-08-18 Capreomycin USP 0.5g Injection Macleods ERP reviewed 22-06-18 Moxifloxacin 0mg disp tablet Macleods ERP reviewed 31-08-18 End of ERP Reviewed products list Phase II, Unit II, Plot No. 25-27 Sr. No. 366, Premier Ind. Estate, Kachigam, Daman Macleods Pharmaceuticals Phase I, Unit II, Plot No. 25-27 Sr. No. 366, Kachigam, Daman Macleods Pharmaceuticals Phase I, Unit II, Plot No. 25-27 Sr. No. 366, Kachigam, Daman pack strip pack Glass vial ml pack Edition: Version 89,16th of May 2018 List of T drugs classified according to the GF Q Policy 21/22

Ref.N o International Nonproprietary name Strength/ Dose Dosage form Supplier/ Manufacturer(s) Global Fund Q Period Validity for ERP Review Edition: Version 89,16th of May 2018 List of T drugs classified according to the GF Q Policy 22/22