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GDF is ISO 9001:2000 compliant for provision of
quality-assured anti-TB drugs and related services to
eligible national TB control programmes.

 
 

 

 

 

 

  
> procurement & supply

Quality Assurance

GDF Quality Assurance Process:

The Global Drug Facility (GDF) procures TB drugs for supply to eligible recipients through its Grant and Direct Procurement Services.

GDF contracted suppliers of TB drugs under the Grant and Direct Procurement Services are selected via competitive processes that ensure that all drugs to be supplied are either prequalified under the WHO Procurement, Quality and Sourcing Programme: Access to Anti-Tuberculosis Drugs of Acceptable Quality (WHO Prequalification Programme) or are approved for supply through a transparent, independent expert committee and are pending WHO Prequalification.

The products GDF procures are subject to the following Quality Assurance criteria†:

  • Manufacturers' compliance with WHO/GMP standards as assessed under the aforementioned WHO Prequalification Programme
  • Product compliance with either:

Option (I): WHO-recommended standards for the quality, safety and efficacy of medicines as assessed under the aforementioned WHO Prequalification Programme, i.e. the product is Prequalified

Or in the absence of such compliance, the product is pending WHO Prequalification and is in

Option (II): compliance with the assessment criteria listed here.The listed criteria are determined by the WHO Prequalification Programme and product dossiers are assessed against these criteria by a transparent, independent expert committee convened by the WHO Prequalification Programme at the request of GDF. The committee is drawn from the same team of evaluators who assess product dossiers for quality aspects and for efficacy and safety under the WHO Prequalification Programme.

Where a product which complies with Option I has at least 3 manufacturers who comply with GDF tender criteria (click here for more details on tender criteria), GDF limits procurement of that product to those manufacturers.

  • All batches of all products procured by GDF, irrespective of whether product compliance falls under option I or option II, are subject to independent quality control testing by a laboratory that (a) is from a country that is a member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S) (b) from a country that is party to the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) or (c) has been assessed by WHO PSM/QSM and found to meet recommended international norms and standards for the analysis of products.

†Streptomycin, Water for Injection and Hypodermic Syringes are the only exception, whereby GMP is based on approval of the National Regulatory Authority of the manufacturing country as per WHO Guidelines. Option II still applies for Streptomycin and Water for Injection as does independent quality control testing as indicated immediately above.

Table 3: TB Products currently supplied through GDF and their status with respect to (a) Option I or II above and (b) GMP Compliance of their site of manufacture

TB ProductUnitSupplierProduct Prequalification Status: Option I or IICompliance with WHO GMP (as assessed under WHO Prequalification Program)YES/NO WHO Public Inspection Reports: http://mednet3.who.int/prequal/GDF Product
No.Code
Rifampicin 150 mg / Isoniazid 75 mg / Pyrazinamide 400 mg / Ethambutol 275 mg film coated tabletsbox of 672 tablets in 24 blister sheetsPRIMARY:

Svizera Europe BV		Option IIYES. Site: Svizera Private Labs Limited, Plot No D16/6, TTC Industrial Area, MIDC, Turbhe, Navi, Mumbai - 400 703, India14FDC-B SE/p
SECONDARY:

Sandoz Pty Ltd., Sector of Novartis		Option I (Ref. No.: 090)YES. Site: Strides Arcolab, KRS Gardens, Suragajakanahalli, Indhawadi Cross, Annekal, Taluk, Bangalore 562, India14FDC-B SA/s
Rifampicin 150 mg / Isoniazid 75 mg / Pyrazinamide 400 mg / Ethambutol 275 mg film coated tablets1000 tablets/unitPRIMARY:

Lupin Laboratories Ltd.		Option I (Ref. No.: 070)YES. Site: A-28/1, MIDC Industrial Area, Chikalthana, Aurangabad 431 210, India24FDC LU/p
SECONDARY:

Sandoz Pty Ltd., Sector of Novartis		Option I (Ref. No.: 090)YES. Site: Strides Arcolab, KRS Gardens, Suragajakanahalli, Indhawadi Cross, Annekal, Taluk, Bangalore 562, India24FDC SA/s
Rifampicin 150 mg / Isoniazid 75 mg /Ethambutol 275 mg film coated tabletsbox of 672 tablets in 24 blister sheetsLupin Laboratories Ltd.Option IIYES. Site: A-28/1, MIDC Industrial Area, Chikalthana, Aurangabad 431 210, India33FDC-B LU/p
Rifampicin 150 mg / Isoniazid 75 mg /Ethambutol 275 mg film coated tablets1000 tablets/unitLupin Laboratories Ltd.Option IIYES. Site: A-28/1, MIDC Industrial Area, Chikalthana, Aurangabad 431 210, India43FDC LU/p
Rifampicin 150 mg / Isoniazid 75 mg, film coated tabletsbox of 672 tablets in 24 blister sheetsPRIMARY:

Lupin Laboratories Ltd.		Option I (Ref. No.: 068)YES. Site: A-28/1, MIDC Industrial Area, Chikalthana, Aurangabad 431 210, India5RH150/75-B LU/p
SECONDARY:

Sandoz Pty Ltd., Sector of Novartis		Option I (Ref. No.: 085)YES. Site: Strides Arcolab, KRS Gardens, Suragajakanahalli, Indhawadi Cross, Annekal, Taluk, Bangalore 562, India5RH150/75-B SA/s
Rifampicin 150 mg / Isoniazid 75 mg, film coated tablets1000 tablets/unitPRIMARY:

Lupin Laboratories Ltd.		Option I (Ref. No.: 068)YES. Site: A-28/1, MIDC Industrial Area, Chikalthana, Aurangabad 431 210, India6RH150/75 LU/p
SECONDARY:

Svizera Europe BV		Option IIYES. Site: Svizera Private Labs Limited, Plot No D16/6, TTC Industrial Area, MIDC, Turbhe, Navi, Mumbai - 400 703, India6RH150/75 SE/s
Rifampicin 150 mg / Isoniazid 150 mg, film coated tabletsbox of 672 tablets in 24 blister sheetsPRIMARY:

Lupin Laboratories Ltd.		Option IIYES. Site: A-28/1, MIDC Industrial Area, Chikalthana, Aurangabad 431 210, India7RH150/150-B LU/p
SECONDARY:

Svizera Europe BV		Option IIYES. Site: Svizera Private Labs Limited, Plot No D16/6, TTC Industrial Area, MIDC, Turbhe, Navi, Mumbai - 400 703, India7RH150/150-B SE/s
Rifampicin 150 mg / Isoniazid 150 mg, film coated tablets1000 tablets/unitPRIMARY:

Lupin Laboratories Ltd.		Option IIYES. Site: A-28/1, MIDC Industrial Area, Chikalthana, Aurangabad 431 210, India8RH150/150 LU/p
SECONDARY:

Svizera Europe BV		Option IIYES. Site: Svizera Private Labs Limited, Plot No D16/6, TTC Industrial Area, MIDC, Turbhe, Navi, Mumbai - 400 703, India8RH150/150 SE/s
Ethambutol 400 mg / Isoniazid 150 mg film coated tabletsbox of 672 tablets in 24 blister sheetsPRIMARY:

Svizera Europe BV		Option IIYES. Site: A-28/1, MIDC Industrial Area, Chikalthana, Aurangabad 431 210, India9EH400/150-B SE/p
SECONDARY:

Cadila Pharmaceuticals Ltd.		Option IIYES. Site: 1389 Dholka Road, Bhat, Ahmedabad, Gujarat State, India9EH400/150-B CA/s
Ethambutol 400 mg / Isoniazid 150 mg film coated tabletsbox of 672 tablets in 24 blister sheetsPRIMARY:

Svizera Europe BV		Option IIYES. Site: A-28/1, MIDC Industrial Area, Chikalthana, Aurangabad 431 210, India10EH400/150 SE/p
SECONDARY:

Lupin Laboratories Ltd.		Option IIYES. Site: A-28/1, MIDC Industrial Area, Chikalthana, Aurangabad 431 210, India10EH400/150 LU/s
Ethambutol HCI 400 mg film coated tabletsbox of 672 tablets in 24 blister sheetsPRIMARY:

Cadila Pharmaceuticals Ltd.		Option I (Ref. No.: 08)YES. Site: 1389 Dholka Road, Bhat, Ahmedabad, Gujarat State, India11E400-B CA/p
SECONDARY:

Svizera Europe BV		Option IIYES. Site: Svizera Private Labs Limited, Plot No D16/6, TTC Industrial Area, MIDC, Turbhe, Navi, Mumbai - 400 703, India11E400-B SE/s
Ethambutol HCI 400 mg film coated tablets1000 tablets/unitPRIMARY:

Cadila Pharmaceuticals Ltd.		Option I (Ref. No.: 08)YES. Site: 1389 Dholka Road, Bhat, Ahmedabad, Gujarat State, India12E400 CA/p
SECONDARY I:

Svizera Europe BV		Option IIYES. Site: Svizera Private Labs Limited, Plot No D16/6, TTC Industrial Area, MIDC, Turbhe, Navi, Mumbai - 400 703, India12E400 SE/s
SECONDARY II:

Lupin Laboratories Ltd.		Option IIYES. Site: A-28/1, MIDC Industrial Area, Chikalthana, Aurangabad 431 210, India12E400 LU/s
Isoniazid 300 mg tabletbox of 672 tablets in 24 blister sheetsPRIMARY:

Cadila Pharmaceuticals Ltd.		Option IIYES. Site: 1389 Dholka Road, Bhat, Ahmedabad, Gujarat State, India13H300-B CA/p
SECONDARY:

Svizera Europe BV		Option IIYES. Site: Svizera Private Labs Limited, Plot No D16/6, TTC Industrial Area, MIDC, Turbhe, Navi, Mumbai - 400 703, India13H300-B SE/s
Isoniazid 300 mg tablet1000 tablets/unitCadila Pharmaceuticals Ltd.Option IIYES. Site: 1389 Dholka Road, Bhat, Ahmedabad, Gujarat State, India14H300 CA/p
Pyrazinamide 400 mg tabletsbox of 672 tablets in 24 blister sheetsPRIMARY:

Cadila Pharmaceuticals Ltd.		Option I (Ref. No.: 015)YES. Site: 1389 Dholka Road, Bhat, Ahmedabad, Gujarat State, India15Z400-B CA/p
SECONDARY:

Macleods Pharmaceuticals Ltd.		Option I (Ref. No.: 159)YES. Site: Macleods Pharmaceuticals Limited Plot No. 25-27, Survey No. 366, Premier Industrial Estate, Kachigam, Daman UT India15Z400-B MC/s
Pyrazinamide 400 mg tablets1000 tablets/unitPRIMARY:

Cadila Pharmaceuticals Ltd.		Option I (Ref. No.: 084)YES. Site: 1389 Dholka Road, Bhat, Ahmedabad, Gujarat State, India16Z400 CA/p
SECONDARY:

Macleods Pharmaceuticals Ltd.		Option I (Ref. No.: 159)YES. Site: Macleods Pharmaceuticals Limited Plot No. 25-27, Survey No. 366, Premier Industrial Estate, Kachigam, Daman UT India16Z400 MC/s
Streptomycin (as sulphate) powder for injection 1 g50 vials/unitPRIMARY:

Shijiazhuang Pharma. Group Co. Ltd (Shijiazhuang Nš II).

via Svizera Europe BV		Option IINO - GMP as per WHO Guidelines is based on approval of the National Regulatory Authority of the manufacturing country: China17S1 SE/p
SECONDARY:

Macleods Pharmaceuticals Ltd.		Option IIYES. Site: Macleods Pharmaceuticals Limited Plot No. 25-27, Survey No. 366, Premier Industrial Estate, Kachigam, Daman UT India17S1 CA/s
Water for injection5 ml vial, 100 vials/unitPRIMARY:

Claris Lifesciences Ltd.,

via Svizera Europe BV		Option IINO - GMP as per WHO Guidelines is based on approval of the National Regulatory Authority of the manufacturing country: China18W5ml SE/p
SECONDARY:

Marck Biosciences Ltd., India

via Macleods Pharmaceuticals Ltd.		Option IINO - GMP as per WHO Guidelines is based on approval of the National Regulatory Authority of the manufacturing country: China18W5ml CA/s
Hypodermic syringe5ml, disposable, w/by-packed needle: 0.8mmx 40mm (21G), 100/boxPRIMARY:

Becton, Dickinson & Company (BD),

via Svizera Europe BV		n/aNO - GMP as per WHO Guidelines is based on approval of the National Regulatory Authority of the manufacturing country: Spain19HS5ml SE/p
Hypodermic syringe5ml, with automatic disabling feature after 2nd cycle, disposable, w/by-packed needle: 0.8mmx 40mm (21G), 100/boxSECONDARY:

Becton, Dickinson & Company (BD),

via Svizera Europe BV		n/aNO - GMP as per WHO Guidelines is based on approval of the National Regulatory Authority of the manufacturing country: Spain20ADHS5ml SE/p
Cat. I & III kit type A 6 blister sheets of 28 FDC-tablets (=168 tablets) RH150/H75/Z400/E275 12 blisters of 28 FDC-tablets (= 336 tablets) R150/H75, 1 unit in a box" "Cat. I & III kit type B 6 blister sheets of 28 FDC-tablets (=168 tablets) RH150/H75/Z400/E275 18 blisters of 28 FDC-tablets (= 504 tablets) E400/H150, 1 unit in a box"1 Kit

Sandoz Pty Ltd., Sector of Novartis		Option I (Ref. No.: 090)

and

Option I (Ref. No.: 085)		YES. SSite: Strides Arcolab, KRS Gardens, Suragajakanahalli, Indhawadi Cross, Annekal, Taluk, Bangalore 562, India21Kit I+III A SA/p
Cat. I & III kit type A
6 blister sheets of 28 FDC-tablets (=168 tablets) RH150/H75/Z400/E275 12 blisters of 28 FDC-tablets (= 336 tablets) R150/H75, 1 unit in a box" "Cat. I & III kit type B 6 blister sheets of 28 FDC-tablets (=168 tablets) RH150/H75/Z400/E275 18 blisters of 28 FDC-tablets (= 504 tablets) E400/H150, 1 unit in a box"		1 Kit

Svizera Europe BV		Option II YES. Site: Svizera Private Labs Limited, Plot No D16/6, TTC Industrial Area, MIDC, Turbhe, Navi, Mumbai - 400 703, India21Kit I+III A SE/s
Cat. I & III kit type B
6 blister sheets of 28 FDC-tablets (=168 tablets) RH150/H75/Z400/E275 18 blisters of 28 FDC-tablets (= 504 tablets) E400/H150, 1 unit in a box 		1 Kit

Svizera Europe BV		Option II YES. Site: Svizera Private Labs Limited, Plot No D16/6, TTC Industrial Area, MIDC, Turbhe, Navi, Mumbai - 400 703, India22Kit I+III B SE/p
Cat. I & III kit type C
6 blister sheets of 28 FDC-tablets (=168 tablets) RH150/H75/Z400/E275 6 blisters of 28 FDC-tablets (= 168 tablets) R150/H150, 1 unit in a box 		1 Kit

Svizera Europe BV		Option II YES. Site: Svizera Private Labs Limited, Plot No D16/6, TTC Industrial Area, MIDC, Turbhe, Navi, Mumbai - 400 703, India23Kit I+III C SE/p
Cat. I & III kit type A1
9 blisters of 28 FDC-tablets (=252 tablets) R150/H75/Z400/E275 15 blisters of 28 FDC-tablets (= 420 tablets) R150/H75/E275, as one tablet box 60 vials of streptomycin 1g 60 vials of water for injection 5ml 60 Hypodermic syringes, 5 ml with automatic disabling feature after 2nd cycle, disposable, sterile, with by-packed needle: 0.8 mm x 40 mm (21G) 1 needle hub cutter, as one injectables box 		1 Kit

Svizera Europe BV		Option II YES. Site: Svizera Private Labs Limited, Plot No D16/6, TTC Industrial Area, MIDC, Turbhe, Navi, Mumbai - 400 703, India

S+W NO - GMP as per WHO Guidelines is based on approval of the National Regulatory Authority of the manufacturing country: China/India		24Kit II A1 SE/p
Cat. I & III kit type A2
9 blisters of 28 FDC-tablets (=252 tablets) R150/H75/Z400/E275 15 blisters of 28 FDC-tablets (= 420 tablets) R150/H75/E275, as one tablet box 60 vials of streptomycin 1g 60 vials of water for injection 5ml 60 Hypodermic syringes, 5 ml, 2-part, luer, disposable, sterile, with by-packed needle: 0.8 mm x 40 mm (21G),1 needle hub cutter, as one injectables box 		1 Kit

Svizera Europe BV		Option II YES. Site: Svizera Private Labs Limited, Plot No D16/6, TTC Industrial Area, MIDC, Turbhe, Navi, Mumbai - 400 703, India

S+W NO - GMP as per WHO Guidelines is based on approval of the National Regulatory Authority of the manufacturing country: China/India		25Kit II A2 SE/p
Cat. I & III kit type B1
9 blisters of 28 FDC-tablets (=252 tablets) R150/H75/Z400/E275 15 blisters of 28 FDC-tablets (= 420 tablets) R150/H75 10 blisters of 28 FDC-tablets E400 (= 280 tablets), as one tablet box 60 vials of streptomycin 1g 60 vials of water for injection 5ml 60 Hypodermic syringes, 5 ml with automatic disabling feature after 2nd cycle, disposable, sterile, with by-packed needle: 0.8 mm x 40 mm (21G) 1 needle hub cutter, as one injectables box" 		1 Kit

Svizera Europe BV		Option II YES. Site: Svizera Private Labs Limited, Plot No D16/6, TTC Industrial Area, MIDC, Turbhe, Navi, Mumbai - 400 703, India

S+W NO - GMP as per WHO Guidelines is based on approval of the National Regulatory Authority of the manufacturing country: China/India		26Kit II B1 SE/p
Cat. I & III kit type B2
9 blisters of 28 FDC-tablets (=252 tablets) R150/H75/Z400/E275 15 blisters of 28 FDC-tablets (= 420 tablets) R150/H75 10 blisters of 28 FDC-tablets E400 (= 280 tablets), as one tablet box.60 vials of streptomycin 1g 60 vials of water for injection 5ml 60 Hypodermic syringes, 5 ml with automatic disabling feature after 2nd cycle, disposable, sterile, with by-packed needle: 0.8 mm x 40 mm (21G) 1 needle hub cutter, as one injectables box"		1 Kit

Svizera Europe BV		Option II YES. Site: Svizera Private Labs Limited, Plot No D16/6, TTC Industrial Area, MIDC, Turbhe, Navi, Mumbai - 400 703, India

S+W NO - GMP as per WHO Guidelines is based on approval of the National Regulatory Authority of the manufacturing country: China/India		27Kit I+II B2