Medicines/finished pharmaceutical products

Reference Number: 
TB159

Date of prequalification: 
23 March 2007
Basis of listing: 
Prequalified by WHO
Status: 
Active
INN: 
Pyrazinamide
Therapeutic area: 
Tuberculosis
Dosage form & strength: 
Tablet 400mg
Storage condition: 
Do not store above 30°C, protect from moisture
Shelf life (months): 
48
Packaging: 
Blister Alu/PVC: 10x3, 10x10, 28x3, 28x24, 10x24, 10x28; Alu/PVDC /PVC blister: 10x3, 10x10, 28x3, 28x10, 28x24, HDPE Bottle: 500x1, 1000x1
Applicant: 
Macleods Pharmaceuticals Ltd, 304 Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai, 400 059, India
FPP Manufacturing Site: 

Oxalis Labs, Vill. Theda, P.O.lodhimajra, Baddi, Distt. Solan, India
Macleods Pharmaceuticals Ltd, Unit 2, Plot No 25-27, Survey No 366, Premier Industrial Estate, Kachigam, Daman, 396 210, 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