Product Details
WHO Product ID
TB369
Status
Prequalified
INN, dosage form and strength
Isoniazid/Rifapentine Tablet, Film-coated 300mg/300mg
Date of prequalification
Basis of listing
Prequalification - Full
Therapeutic area
Tuberculosis
Type
Finished Pharmaceutical Product
Dosage form
Tablet, Film-coated
Applicant organization
Macleods Pharmaceuticals Ltd
304 Atlanta Arcade, Marol Church Road, Andheri (East)
Mumbai,
400 059
India
Packaging details and storage conditions
Packaging Type
Strip, Alu/Alu
Configuration
6x7, 12x3
Shelf life (months)
36
Storage conditions
Do not store above 30°C, protect from moisture
API Manufacturing Site(s)
By Organization
By Active Ingredient
Amsal Chem Pvt Ltd
A-1/401-402-403 GIDC Area, Bharuch District
Ankleshwar,
Gujarat
393 002
India
Isoniazid
Macleods Pharmaceuticals Ltd
Plot No 2209 GIDC Industrial Estate At and Post Sarigam, Taluka: Umbergaon Dist: Valsad
Gujarat
396 155
India
Rifapentine
Second Pharma Co Ltd
No. 33, Weiwu Road, Hangzhou Gulf Fine Chemical Zone
Shangyu,
Zhejiang
312 369
China
Isoniazid
FPP Manufacturing Site(s)
Oxalis Labs
Vill. Theda, Baddi, Distt. Solan
P.O.lodhimajra,
174101
India