Molecules / Dolutegravir

Dolutegravir API manufacturers

CAS 1051375-16-6 ATC J05AX12 Updated 9 July 2026
19
manufacturers with an active filing 19 of them hold a US DMF or a CEP
$410.59
median export price per kg $299.12 to $3035.72 · 10 exporters · 2025
4
shortage records on file across 3 countries
235
finished-dose makers across 47 regulators
Showing 19 of 19 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Hetero

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for dolutegravir, filing since 2016. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
02

Lupin

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for dolutegravir, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
30 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
03

Macleods Pharmaceuticals

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dolutegravir, filing since 2017. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
29 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Micro Labs

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dolutegravir, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 20 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
20 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
05

Laurus Labs

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds 8 active US DMFs for dolutegravir, filing since 2016. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.

US DMF
8 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
13 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Lek Pharmaceuticals D.D

Slovenia
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dolutegravir, filing since 2016. Its GMP is recognised in 13 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
13 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
07

Cipla

India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds 3 active US DMFs for dolutegravir, filing since 2016. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
3 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
08

MSN Life Sciences

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for dolutegravir, filing since 2016. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 4 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
4 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Chongqing Carelife Pharmaceutical

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dolutegravir, filing since 2024. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
10

Apitoria Pharma

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dolutegravir, filing since 2014. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
11

Arene Life Sciences

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for dolutegravir, filing since 2020. Its 2024 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
12
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dolutegravir, filing since 2016. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
13

Viyash Life Sciences

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dolutegravir, filing since 2022. Its 2025 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
14

Emnar Pharma

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for dolutegravir, filing since 2026. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
15

Matrix Pharmacorp

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for dolutegravir, filing since 2015. Its 2025 FDA inspection closed as VAI.

US DMF
2 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
16
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dolutegravir, filing since 2025. Its 2024 FDA inspection closed as VAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
17

Chromo Laboratories India

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds 2 active US DMFs for dolutegravir, filing since 2021. Its 2018 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
2 active
CEP
None on file
Last FDA inspection
2018 · VAI
GMP recognised in
1 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
18

Styrax Pharma

India
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for dolutegravir, filing since 2022.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile

16 more manufacturers hold filings for dolutegravir

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

Micro LabsLaurus LabsLek Pharmaceuticals D.DCiplaMSN Life SciencesChongqing Carelife PharmaceuticalApitoria PharmaArene Life SciencesShanghai Desano Chemical PharmaceuticalViyash Life SciencesEmnar PharmaMatrix PharmacorpShijiazhuang Lonzeal PharmaceuticalsChromo Laboratories IndiaStyrax PharmaSuzhou Ryway Biotech
Open the full list with a free account

Contract manufacturers (3)

Arene Life Sciences India Zhejiang Langhua Pharmaceutical China Anhui Biochem Pharmaceutical China

Contract manufacturers make to order rather than holding their own filing for this molecule.

Finished-dose makers (16)

Viatris United States Glaxo Operations Uk United Kingdom Strides Pharma Science India Synthimed Labs India Zentiva, k.s Czech Republic Aurore pharmaceuticals India Bristol-Myers Squibb United States Delpharm Montréal Canada Sandoz Switzerland Cipla Quality Chemical Industries Uganda Delpharm Poznan Poland GlaxoSmithKline United States LEO Pharma A/S Denmark Strides Shasun India Aurobindo Pharma India Baxter Healthcare United States

How this list is built

The order is set by active filings weighted by regulator, inspection outcomes and their recency, breadth of GMP recognition, and evidence of real exports, less any open risk flags. Every factor appears on the card it produced. Read the full method.

Active US DMFs
FDA, List of Drug Master Files
Valid CEPs
EDQM certificate database
Inspection outcomes
FDA inspection classifications
GMP certificates
EudraGMDP and national regulators
Price band
Customs export unit values for 2025. These are export values rather than contract prices for regulated-market grade material, which are higher.

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Also on this molecule

Price history 4 yrs Shortages 4 Recalls 6 Finished dose 16 Contract mfrs 3

By country

India 25 China 8

Export price by year

Year Median Exporters
2025 $410.59 10
2024 $404.00 18
2023 $700.86 25
2022 $1079.24 12

US dollars per kilogram, customs export unit values.