Molecules / Darunavir

Darunavir API manufacturers

CAS 206361-99-1 ATC J05AE10 Updated 9 July 2026
14
manufacturers with an active filing 14 of them hold a US DMF or a CEP
$407.72
median export price per kg $340.00 to $452.18 · 12 exporters · 2025
18
shortage records on file across 6 countries
259
finished-dose makers across 43 regulators
Showing 14 of 14 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 4 active US DMFs for darunavir, filing since 2010. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.

US DMF
4 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
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02

Lupin

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

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

US DMF
1 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

Micro Labs

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

Holds one active US DMF for darunavir, filing since 2015. 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
04

MSN Laboratories

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

Holds 2 active US DMFs for darunavir, 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
05

Laurus Labs

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

Holds 4 active US DMFs for darunavir, filing since 2017. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.

US DMF
4 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

Cipla

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

Holds 4 active US DMFs for darunavir, filing since 2010. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.

US DMF
4 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
07

Zydus Lifesciences

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

Holds one active US DMF for darunavir, filing since 2019. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.

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

Raks Pharma

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

Holds one active US DMF for darunavir, filing since 2016. Its 2025 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
09

Innovare Labs

India
Makes the API

Holds one active US DMF for darunavir, filing since 2021. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · VAI
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 darunavir, filing since 2017. 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

Porton Pharma Solutions

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

Holds one active US DMF for darunavir, filing since 2019. Its 2024 FDA inspection closed as NAI.

US DMF
1 active
CEP
None on file
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
How this listing is sourced FDA, List of Drug Master Files
View profile
12

Arene Life Sciences

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

Holds 2 active US DMFs for darunavir, filing since 2023. 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
13

Matrix Pharmacorp

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

Holds 3 active US DMFs for darunavir, filing since 2010. Its 2025 FDA inspection closed as VAI.

US DMF
3 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

Chromo Laboratories India

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

Holds 2 active US DMFs for darunavir, filing since 2024. 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

11 more manufacturers hold filings for darunavir

The names are listed below. Ask Fred about the filings, inspection history and GMP certificates on record for each manufacturer.

MSN LaboratoriesLaurus LabsCiplaZydus LifesciencesRaks PharmaInnovare LabsApitoria PharmaPorton Pharma SolutionsArene Life SciencesMatrix PharmacorpChromo Laboratories India
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Contract manufacturers (1)

Arene Life Sciences India

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

Finished-dose makers (28)

Dr. Reddy's Laboratories India Viatris United States Zentiva, k.s Czech Republic Janssen-Cilag Farmaceutica Ltda Brazil Apotex Canada Glenmark Pharmaceuticals s.r.o Czech Republic Teva Israel MSN Laboratories India Sandoz Switzerland Jamp Pharma Canada Janssen Ortho Puerto Rico Janssen Pharmaceutica Belgium Krka Slovenia STADA Arzneimittel Germany Pharmathen Greece Remedica Cyprus Sai Mirra Innopharm India Aurobindo Pharma India Beta Healthcare International Kenya Dawa Kenya

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.

Who makes darunavir?

Ask Fred which manufacturers are on record for darunavir and what filings they hold.

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Also on this molecule

Price history 4 yrs Shortages 18 Finished dose 28 Contract mfrs 1

By country

India 13

Export price by year

Year Median Exporters
2025 $407.72 12
2024 $445.62 11
2023 $595.00 12
2022 $719.87 13

US dollars per kilogram, customs export unit values.