Product details
WHO Product ID
WHOAPI-507
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Conversion
Therapeutic area
Tuberculosis
Type
None
Grade
Standard
INN
Rifampicin
Confirmation of WHO API prequalification document (version date)
Applicant organization
Macleods Pharmaceuticals Ltd
G-2 Mahakali Caves Road, Shanti Nagar, Andheri (E)
Mumbai,
Maharashtra
400 093
India
APIMF Version Number
Macleods/ Rifampicin /AP/01/2024-09-16
Macleods/ Rifampicin /RP/01/2024-09-16
Macleods/ Rifampicin /RP/01/2024-09-16
Product Grades
API specification number
CO-SPC/ARD/RM004717A-008
Storage condition
Do not store above 25°C, protect from moisture, protect from light
Storage period (months)
12
Duration type
Retest period
Packaging
Transparent LDPE Bag put into Black LDPE Bag. Silicagel and oxygen scavenger is placed between the bags. The LDPE bags are inserted together with Silicagel and oxygen scavenger in a triple laminated bag, sealed and kept in a HDPE container. All packaging operations are performed under nitrogen.
API Manufacturing Site(s)
Macleods Pharmaceuticals Ltd
Plot No 2209 GIDC Industrial Estate At and Post Sarigam, Taluka: Umbergaon Dist: Valsad
Gujarat
396 155
India
Macleods Pharmaceuticals Ltd
Plot No D-3/27 GIDC, Dahej-III
Village Sambheti, District Bharuch,
Gujarat
392130
India