WHO Product ID
TB090
Status
Prequalified
INN, dosage form and strength
Ethambutol hydrochloride/Isoniazid/Pyrazinamide/Rifampicin Tablet, Film-coated 275mg/75mg/400mg/150mg
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Sandoz Pvt Ltd
K-3 MDT-TB, Plot No 8 A/2 & 8-B, TTC Industrial Area, MIDC, Kalwe Block, Dighe Village, Thane District
Navi Mumbai,
Maharashtra
400 708
India
Packaging details and storage conditions
Packaging Type
Blister, Alu-PVC/PE/PVdC
Configuration
28x24
Shelf life (months)
24
Storage conditions
Do not store above 25°C. Store in the original package in order to protect from moisture. Avoid excursions above 30°C.
API Manufacturing Site(s)
By Organization
By Active Ingredient
Calyx Chemicals & Pharmaceuticals Ltd
Plot No-102/91/90, MIDC Industrial Area, Boisar
Tarapur,
Maharashtra
401 506
India
Pyrazinamide
Chong Kun Dang (CKD) Bio Corporation
292, Sinwon-ro, Denwon-gu, Ansan-si, Gyeonggi-do
Seoul,
15604
Republic of Korea
Rifampicin
Lupin Ltd
Plot No. 09, 123, 123/1, 124 & 125 -Ethambutol (ETB) Plant, GIDC Estate
Ankleshwar,
Gujarat
393 002
India
Ethambutol hydrochloride
Yuki Gosei Kogyo Co Ltd
Joban Factory 788, Joban nishigo-machi, Iwaki-city
Fukushima,
972-8316
Japan
Isoniazid
FPP Manufacturing Site(s)
Panacea Biotech Pharma Limited
Malpur, Baddi, Solan District
Tehsil Nalagarh,
Himachal Pradesh
173 205
India
Sandoz Pvt Ltd
K-3 MDT-TB, Plot No 8 A/2 & 8-B, TTC Industrial Area, MIDC, Kalwe Block, Dighe Village, Thane District
Navi Mumbai,
Maharashtra
400 708
India
