Product details
WHO Product ID
WHOAPI-489
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Type
None
Grade
Standard
INN
Lamivudine
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/Lamivudine/OP/00/July-2023, 2023-07-28
SMS/Lamivudine/OP/00/July-2023, 2023-07-28
SMS/Lamivudine/OP/00/July-2023/Amend 01 - Dec-2024
SMS/Lamivudine/RP/00/July-2023/Amend 01 - Dec-2024
SMS/Lamivudine/OP/00/July-2023/Amend 02 - Dec-2025
SMS/Lamivudine/OP/00/July-2023, 2023-07-28
SMS/Lamivudine/OP/00/July-2023/Amend 01 - Dec-2024
SMS/Lamivudine/RP/00/July-2023/Amend 01 - Dec-2024
SMS/Lamivudine/OP/00/July-2023/Amend 02 - Dec-2025
Product Grades
API specification number
CS-FP-5076-06 version 01
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
60
Duration type
Retest period
Packaging
Primary packaging: white LDPE bag.
Secondary packaging: black LDPE bag.
Tertiary packaging: HDPE drum.
Secondary packaging: black LDPE bag.
Tertiary packaging: HDPE drum.
API Manufacturing Site(s)
SMS Pharmaceuticals Ltd
Unit VII, Kandivalasa Village, Poosapatirega (M), Vizianagaram District
Andhra Pradesh
535 204
India