WHOAPI-362: Dolutegravir (sodium) | WHO - Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control)

Product details

WHO Product ID

WHOAPI-362

Status

Prequalified

Date of prequalification

19 Nov, 2019

Basis of listing

Prequalification - Standard

Therapeutic area

HIV/AIDS

Type

None

Grade

Standard

INN

Dolutegravir (sodium)

Confirmation of WHO API prequalification document (version date)

19 Sep, 2025

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/DGS/AP/001/03, April 2022
MLL/DGS/RP/001/03, April 2022
MLL/DGS/AP/001/03, April 2022/Amend-01, September 2022
MLL/DGS/RP/001/03, April 2022/Amend-01, September 2022
MLL/DGS/AP/001/03, April 2022/Amend-01, September 2022; Amend-02, February 2024
MLL/DGS/RP/001/03, April 2022/Amend-01, September 2022; Amend-02, February 2024
MLL/DGS/AP/001/03, April 2022/Amend-01, September 2022; Amend-02, February 2024; Amend-03, April 2024
MLL/DGU/AP/001/03, April 2022/Amend-05, February 2025
MLL/DGU/RP/001/03, April 2022/ Amend-04, February 2025
MLL/DGU/AP/001/03, April 2022/Amend-06, September 2025
MLL/DGU/RP/001/03, April 2022/ Amend-05, September 2025

Product Grades

API specification number

STP/DGS/FPR/004/04

Storage condition

Do not store above 30°C, protect from light

Storage period (months)

Duration type

Retest period

Packaging

White polyethylene bag (LDPE), placed in a HMLDPE bag. Both bags are placed in triple laminated aluminium bag and packed in HDPE drums.

API Manufacturing Site(s)

Matrix Pharmacorp Private Limited

Unit 9, Road No 12, Plot No. 5, Jawaharlal Nehru Pharma City, Tadi Village, Parawada (M), Anakapalli District

Visakhapatnam,

Andhra Pradesh

531019

India