Product details
WHO Product ID
WHOAPI-211
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
Influenza
Type
None
Grade
Standard
INN
Oseltamivir (phosphate)
Confirmation of WHO API prequalification document (version date)
Applicant organization
Matrix Pharmacorp Private Limited
Plot No. 14, 99 and 100, IDA Pashamylaram Phase-II
Patancheru, Sangareddy District,
Telangana
502307
India
APIMF Version Number
MLL/OST/AP/001/04/December 2020
MLL/OST/RP/001/04/December 2020
MLL/OST/AP/001/04/December 2020/Amend 01, June 2024
MLL/OST/RP/001/04/December 2020/Amend 01, June 2024
MLL/OST/AP/001/04/ December 2020; Amend-02, September 2025
MLL/OST/RP/001/04/ December 2020; Amend-02, September 2025
MLL/OST/RP/001/04/December 2020
MLL/OST/AP/001/04/December 2020/Amend 01, June 2024
MLL/OST/RP/001/04/December 2020/Amend 01, June 2024
MLL/OST/AP/001/04/ December 2020; Amend-02, September 2025
MLL/OST/RP/001/04/ December 2020; Amend-02, September 2025
Product Grades
API specification number
STP/FPR/OST/002/06
Storage condition
Do not store above 30°C, protect from moisture
Storage period (months)
60
Duration type
Retest period
Packaging
LDPE bag, which after nitrogen flushing, is inserted into HMLDPE bag heat sealed. Both these bags are then put into an outer triple laminated aluminium bag and heat sealed.
API Manufacturing Site(s)
Matrix Pharmacorp Private Limited
Unit 1, Survey 10, Kazipally Industrial Area Gaddapotharam, Sangareddy District
Hyderabad,
Telangana
502 319
India