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WHOAPI-519: Lamivudine

Product details
WHO Product ID
WHOAPI-519
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Therapeutic area
HIV/AIDS
Type
None
Grade
PG-APIMF519-Standard
INN
Lamivudine
Reference authority
European Directorate for the Quality of Medicines & Healthcare (EDQM)
Confirmation of WHO API prequalification document (version date)
Applicant organization
Arene Life Sciences Private Limited
S.R.CHAMBERS, # 3-58
Ramachandrapuram, Sangareddy,
Telangana
502 032
India
APIMF Version Number
ALS/LVD/AP/00/September-2024
ALS/LVD/RP/00/September-2024
ALS/LVD/AP/00/September-2024/Amend-01-Sep-2025
ALS/LVD/RP/00/September-2024/Amend-01-Sep-2025
ALS/LVD/AP/00/September-2024/Amend-02-Mar-2026
ALS/LVD/RP/00/September-2024/Amend-02-Mar-2026
Product Grades
Storage condition
Do not store above 30°C, protect from light
Storage period (months)
60
Duration type
Retest period
Packaging
Primary packaging:
Translucent low-density polyethylene (LDPE) bag and tied with a plastic fastener as primary packing material.
Secondary Packaging material:
Black low-density polyethylene (LDPE) bag and tied with a plastic fastener as secondary packing material.
Tertiary packaging material:
LDPE bags are placed into a high density polyethylene (HDPE) carboy.
API Manufacturing Site(s)
Arene Life Sciences Private Limited (Unit-1)
Unit-1, Plot No. 48, 49 & 50, 209, 210 & 211, Phase-II, IDA,, Sangareddy
Pashamylaram,
Telangana
502 307
India

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