Medicines/finished pharmaceutical products

Reference Number: 
TB307

Date of prequalification: 
07 December 2016
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Pyrazinamide
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet, Dispersible 150mg
Storage condition: 
Do not store above 30°C, store in dry condition, protect from light
Shelf life (months): 
36
Packaging: 
Bottle, HDPE 100x1 in triple laminated sachet
Applicant: 
Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India
FPP Manufacturing Site: 

Macleods Pharmaceuticals Ltd, Block No. N2, Village Theda, P.O. Lodhi Majra, Tehsil Baddi, District Solan, Himachal Pradesh, 174 101, India

API Manufacturing Site: 

(Pyrazinamide) Anuh Pharma Ltd, E17/3 & 17/4 MIDC, Boisar, Tarapur, Thane District, Maharashtra, 401 506, India
(Pyrazinamide) Calyx Chemicals & Pharmaceuticals Ltd, Plot No-102/91/90, MIDC Industrial Area, Tarapur, Boisar, Maharashtra, 401 506, India
(Pyrazinamide) Macleods Pharmaceuticals Ltd, Plot No 2209 GIDC Industrial Area, At and Post Sarigam, Taluka: Umbergeon, Valsad District, Gujarat, 396 155, India