Product details
WHO Product ID
WHOAPI-375
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Tuberculosis
Grade
Standard
INN
Rifapentine
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
Rifapentine/APIMF/AP/2021-11-25/001
Rifapentine/APIMF/RP/2021-11-25/001
Rifapentine/APIMF/AP/2021-11-25/001-Amendment 01
Rifapentine/APIMF/RP/2021-11-25/001-Amendment 01
Rifapentine/APIMF/RP/2021-11-25/001-Amendment 02
Rifapentine/APIMF/AP/2021-11-25/001 -Amendment 02
Rifapentine/APIMF/RP/2021-11-25/001-Amendment 03
Rifapentine/APIMF/RP/2021-11-25/001
Rifapentine/APIMF/AP/2021-11-25/001-Amendment 01
Rifapentine/APIMF/RP/2021-11-25/001-Amendment 01
Rifapentine/APIMF/RP/2021-11-25/001-Amendment 02
Rifapentine/APIMF/AP/2021-11-25/001 -Amendment 02
Rifapentine/APIMF/RP/2021-11-25/001-Amendment 03
Product Grades
API specification number
C/SPC/RM003463A/06, C/SPC/RM003463S/03 (skip-testing) and C/SPC/RM003463B/02 (customer specific requirements)
Storage condition
Store in a refrigerator (2 °C to 8 °C), protect from moisture, protect from ligh
Storage period (months)
12
Duration type
Retest period
Packaging
Transparent LDPE bag flushed with nitrogen gas followed by vacuum (3x) and twisted and tied. Placed in black LDPE bag with oxygen buster (0.25% of API with 1 x l.5 gm) between the two bags, followed by vacuum (3x) and immediately twisted and tied. Then placed together with oxygen buster (0.25% of API with 1 x l.5 gm) in triple laminated bag followed by vacuum (3x), heat sealed and packed in HDPE containers flushed with nitrogen gas.
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