Medicines/finished pharmaceutical products

Reference Number: 
TB085 (a)

Date of prequalification: 
14 September 2004
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Isoniazid/Rifampicin
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, coated 75mg/150mg
Storage condition: 
Do not store above 30°C, protect from moisture
Shelf life (months): 
24
Packaging: 
Blister Alu/PVC/PE/PVDC: 30, 60, 120, 240, 672, 1000; Bottle PP:500x1; Bottle HDPE: 500x1
Applicant: 
Sandoz Pvt Ltd, K-3 MDT-TB, Plot No 8 A/2 & 8-B, TTC Industrial Area, MIDC, Kalwe Block, Dighe Village, Navi Mumbai, Thane District, Maharashtra, 400 708, India
FPP Manufacturing Site: 

Panacea Biotech Ltd, Malpur, Baddi, Tehsil Nalagarh, Solan District, Himanchal Pradesh, 173 205, India
Panacea Biotech Ltd, Malpur, Baddi, Tehsil Nalagarh, Solan District, Himanchal Pradesh, 173 205, India
Strides Pharma Science Limited, Oral Solid Dosage Forms Division, KRS Gardens, 36/7, Suragajakkanahalli, Indlawadi Cross, Anekal Taluk, Bangalore, Karnataka, 562 106, India
Sandoz Pvt Ltd, K-3 MDT-TB, Plot No 8 A/2 & 8-B, TTC Industrial Area, MIDC, Kalwe Block, Dighe Village, Navi Mumbai, Thane District, Maharashtra, 400 708, India

API Manufacturing Site: 

(Rifampicin) Sandoz Pvt Ltd, Plot L-, Additional Phase MIDC, Mahad, Raigad District, Maharashtra, 402 301, India
(Rifampicin) Sanofi-Aventis SpA, Via Angelo Titi 22-26, Zona ex Punto Franco, Brindisi, 72100, Italy
(Isoniazid) Yuki Gosei Kogyo Co Ltd, Joban Factory 788, Joban nishigo-machi, Iwaki-city, Fukushima, 972-8316, Japan
(Rifampicin) Chong Kun Dang Bio Corporation, Seoul, Republic of Korea

API WHO Public Inspection Reports: