Product details
WHO Product ID
WHOAPI-492
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Therapeutic area
HIV/AIDS
Type
None
Grade
Standard
INN
Darunavir (ethanolate)
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/DEW/AP/00/July-2023
ALS/DEW/RP/00/July-2023
ALS/DEW/AP/00/July-2023/Amend-01-Jul-2024
ALS/DEW/RP/00/July-2023/Amend-01-Jul-2024
ALS/DEW/AP/00/July-2023/Amend-02-Jun-2025
ALS/DEW/RP/00/July-2023/Amend-02-Jun-2025
ALS/DEW/RP/00/July-2023/Amend-03-Feb-2026
ALS/DEW/AP/00/July-2023/Amend-03-Feb-2026
ALS/DEW/RP/00/July-2023
ALS/DEW/AP/00/July-2023/Amend-01-Jul-2024
ALS/DEW/RP/00/July-2023/Amend-01-Jul-2024
ALS/DEW/AP/00/July-2023/Amend-02-Jun-2025
ALS/DEW/RP/00/July-2023/Amend-02-Jun-2025
ALS/DEW/RP/00/July-2023/Amend-03-Feb-2026
ALS/DEW/AP/00/July-2023/Amend-03-Feb-2026
Product Grades
API specification number
STP/FP/DEW/001/04
Storage condition
Do not store above 30°C
Storage period (months)
36
Duration type
Retest period
Packaging
Primary: translucent LDPE bag and tied with a plastic strip seal under nitrogen atmosphere.
Secondary: black LDPE bag and tied with a plastic strip seal under nitrogen atmosphere.
Tertiary: triple laminated aluminum bag and heat sealed as tertiary packing material.
Quaternary: triple laminated bag is placed in HDP) carboy.
Secondary: black LDPE bag and tied with a plastic strip seal under nitrogen atmosphere.
Tertiary: triple laminated aluminum bag and heat sealed as tertiary packing material.
Quaternary: triple laminated bag is placed in HDP) 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