Product details
WHO Product ID
WHOAPI-504
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Type
None
Grade
Standard
INN
Tenofovir disoproxil fumarate
Confirmation of WHO API prequalification document (version date)
Applicant organization
SMS Pharmaceuticals Limited
Plot No. 72, H.No: 8-2-334/3&4 Road No. 5 Opp. SBI Executive Enclave Banjara Hills
Hyderabad,
Telangana
500 034
India
APIMF Version Number
SMS/ATEF/OP/01/March-2026
SMS/ATEF/RP/01/March-2026
SMS/ATEF/RP/01/March-2026
Product Grades
API specification number
CS-FP-5112-05 Version 04
Storage condition
Store in a refrigerator (2°C to 8°C), protect from moisture, protect from light
Storage period (months)
30
Duration type
Retest period
Packaging
Packed in white LDPE bag twist and tied, kept into heat sealed black LDPE bag. Then in heat sealed triple laminated aluminum bag and placed in HDPE drum.
API Manufacturing Site(s)
SMS Pharmaceuticals Ltd
Unit VII, Kandivalasa Village, Poosapatirega (M), Vizianagaram District
Andhra Pradesh
535 204
India