Quality assurance in process of update; see current GDF suppliers in the table below until further notice.
| TB Product | Unit | Supplier | Product Prequalification Status:
Option I or II | Compliance 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 tablets | box of 672 tablets in 24 blister sheets | PRIMARY:
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 | 1 | 4FDC-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, India | 1 | 4FDC-B SA/s |
| Rifampicin 150 mg / Isoniazid 75 mg / Pyrazinamide 400 mg / Ethambutol 275 mg film coated tablets | 1000 tablets/unit | PRIMARY:
Lupin Laboratories Ltd. | Option I (Ref. No.: 070) | YES. Site: A-28/1, MIDC Industrial Area, Chikalthana, Aurangabad 431 210, India | 2 | 4FDC 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, India | 2 | 4FDC SA/s |
| Rifampicin 150 mg / Isoniazid 75 mg /Ethambutol 275 mg film coated tablets | box of 672 tablets in 24 blister sheets | Lupin Laboratories Ltd. | Option II | YES. Site: A-28/1, MIDC Industrial Area, Chikalthana, Aurangabad 431 210, India | 3 | 3FDC-B LU/p |
| Rifampicin 150 mg / Isoniazid 75 mg /Ethambutol 275 mg film coated tablets | 1000 tablets/unit | Lupin Laboratories Ltd. | Option II | YES. Site: A-28/1, MIDC Industrial Area, Chikalthana, Aurangabad 431 210, India | 4 | 3FDC LU/p |
| Rifampicin 150 mg / Isoniazid 75 mg, film coated tablets | box of 672 tablets in 24 blister sheets | PRIMARY:
Lupin Laboratories Ltd. | Option I (Ref. No.: 068) | YES. Site: A-28/1, MIDC Industrial Area, Chikalthana, Aurangabad 431 210, India | 5 | RH150/75-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, India | 5 | RH150/75-B SA/s |
| Rifampicin 150 mg / Isoniazid 75 mg, film coated tablets | 1000 tablets/unit | PRIMARY:
Lupin Laboratories Ltd. | Option I (Ref. No.: 068) | YES. Site: A-28/1, MIDC Industrial Area, Chikalthana, Aurangabad 431 210, India | 6 | RH150/75 LU/p |
SECONDARY:
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 | 6 | RH150/75 SE/s |
| Rifampicin 150 mg / Isoniazid 150 mg, film coated tablets | box of 672 tablets in 24 blister sheets | PRIMARY:
Lupin Laboratories Ltd. | Option II | YES. Site: A-28/1, MIDC Industrial Area, Chikalthana, Aurangabad 431 210, India | 7 | RH150/150-B LU/p |
SECONDARY:
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 | 7 | RH150/150-B SE/s |
| Rifampicin 150 mg / Isoniazid 150 mg, film coated tablets | 1000 tablets/unit | PRIMARY:
Lupin Laboratories Ltd. | Option II | YES. Site: A-28/1, MIDC Industrial Area, Chikalthana, Aurangabad 431 210, India | 8 | RH150/150 LU/p |
SECONDARY:
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 | 8 | RH150/150 SE/s |
| Ethambutol 400 mg / Isoniazid 150 mg film coated tablets | box of 672 tablets in 24 blister sheets | PRIMARY:
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 | 9 | EH400/150-B SE/p |
SECONDARY:
Cadila Pharmaceuticals Ltd. | Option II | YES. Site: 1389 Dholka Road, Bhat, Ahmedabad, Gujarat State, India | 9 | EH400/150-B CA/s |
| Ethambutol 400 mg / Isoniazid 150 mg film coated tablets | 1000 tablets/unit | PRIMARY:
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 | 10 | EH400/150 SE/p |
SECONDARY:
Lupin Laboratories Ltd. | Option II | YES. Site: A-28/1, MIDC Industrial Area, Chikalthana, Aurangabad 431 210, India | 10 | EH400/150 LU/s |
| Ethambutol HCI 400 mg film coated tablets | box of 672 tablets in 24 blister sheets | PRIMARY:
Cadila Pharmaceuticals Ltd. | Option I (Ref. No.: 08) | YES. Site: 1389 Dholka Road, Bhat, Ahmedabad, Gujarat State, India | 11 | E400-B CA/p |
SECONDARY:
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 | 11 | E400-B SE/s |
| Ethambutol HCI 400 mg film coated tablets | 1000 tablets/unit | PRIMARY:
Cadila Pharmaceuticals Ltd. | Option I (Ref. No.: 08) | YES. Site: 1389 Dholka Road, Bhat, Ahmedabad, Gujarat State, India | 12 | E400 CA/p |
SECONDARY I:
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 | 12 | E400 SE/s |
SECONDARY II:
Lupin Laboratories Ltd. | Option II | YES. Site: A-28/1, MIDC Industrial Area, Chikalthana, Aurangabad 431 210, India | 12 | E400 LU/s |
| Isoniazid 300 mg tablet | box of 672 tablets in 24 blister sheets | PRIMARY:
Cadila Pharmaceuticals Ltd. | Option II | YES. Site: 1389 Dholka Road, Bhat, Ahmedabad, Gujarat State, India | 13 | H300-B CA/p |
SECONDARY:
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 | 13 | H300-B SE/s |
| Isoniazid 300 mg tablet | 1000 tablets/unit | Cadila Pharmaceuticals Ltd. | Option II | YES. Site: 1389 Dholka Road, Bhat, Ahmedabad, Gujarat State, India | 14 | H300 CA/p |
| Pyrazinamide 400 mg tablets | box of 672 tablets in 24 blister sheets | PRIMARY:
Cadila Pharmaceuticals Ltd. | Option I (Ref. No.: 015) | YES. Site: 1389 Dholka Road, Bhat, Ahmedabad, Gujarat State, India | 15 | Z400-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 India | 15 | Z400-B MC/s |
| Pyrazinamide 400 mg tablets | 1000 tablets/unit | PRIMARY:
Cadila Pharmaceuticals Ltd. | Option I (Ref. No.: 084) | YES. Site: 1389 Dholka Road, Bhat, Ahmedabad, Gujarat State, India | 16 | Z400 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 India | 16 | Z400 MC/s |
| Streptomycin (as sulphate) powder for injection 1 g | 50 vials/unit | PRIMARY:
Shijiazhuang Pharma. Group Co. Ltd (Shijiazhuang Nš II).
via Svizera Europe BV | Option II | NO - GMP as per WHO Guidelines is based on approval of the National Regulatory Authority of the manufacturing country: China | 17 | S1 SE/p |
SECONDARY:
Macleods Pharmaceuticals Ltd. | Option II | YES. Site: Macleods Pharmaceuticals Limited Plot No. 25-27, Survey No. 366, Premier Industrial Estate, Kachigam, Daman UT India | 17 | S1 CA/s |
| Water for injection | 5 ml vial, 100 vials/unit | PRIMARY:
Claris Lifesciences Ltd.,
via Svizera Europe BV | Option II | NO - GMP as per WHO Guidelines is based on approval of the National Regulatory Authority of the manufacturing country: India | 18 | W5ml SE/p |
SECONDARY:
Marck Biosciences Ltd., India
via Macleods Pharmaceuticals Ltd. | Option II | NO - GMP as per WHO Guidelines is based on approval of the National Regulatory Authority of the manufacturing country: India | 18 | W5ml CA/s |
| Hypodermic syringe | 5ml, disposable, w/by-packed needle: 0.8mmx 40mm (21G), 100/box | PRIMARY:
Becton, Dickinson & Company (BD),
via Svizera Europe BV | n/a | NO - GMP as per WHO Guidelines is based on approval of the National Regulatory Authority of the manufacturing country: Spain | 19 | HS5ml SE/p |
| Hypodermic syringe | 5ml, with automatic disabling feature after 2nd cycle, disposable, w/by-packed needle: 0.8mmx 40mm (21G), 100/box | SECONDARY:
Becton, Dickinson & Company (BD),
via Svizera Europe BV | n/a | NO - GMP as per WHO Guidelines is based on approval of the National Regulatory Authority of the manufacturing country: Spain | 20 | ADHS5ml 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, India | 21 | Kit 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, India | 21 | Kit 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, India | 22 | Kit 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, India | 23 | Kit I+III C SE/p |
Cat. II 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 | 24 | Kit II A1 SE/p |
Cat. II 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 | 25 | Kit II A2 SE/p |
Cat. II 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 | 26 | Kit II B1 SE/p |
Cat. II 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 | 27 | Kit I+II B2 |
