Molecules / Cobicistat

Cobicistat API manufacturers

CAS 1004316-88-4 ATC V03AX03 Updated 9 July 2026
5
manufacturers with an active filing 5 of them hold a US DMF or a CEP
1
shortage records on file across 1 countries
59
finished-dose makers across 18 regulators
Showing 5 of 5 manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked API manufacturers

01

Gilead Sciences

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

Holds one active US DMF for cobicistat, filing since 2011. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 47 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2026 · VAI
GMP recognised in
47 markets
How this listing is sourced FDA, List of Drug Master Files
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02

MSN Laboratories

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

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

US DMF
1 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
03

Honour Lab

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

Holds one active US DMF for cobicistat, filing since 2016. Its 2019 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2019 · VAI
GMP recognised in
2 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Matrix Pharmacorp

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

Holds one active US DMF for cobicistat, filing since 2015. 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
05

Tianish Laboratories

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

Holds one active US DMF for cobicistat, filing since 2014.

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

2 more manufacturers hold filings for cobicistat

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

Matrix PharmacorpTianish Laboratories
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Finished-dose makers (11)

Bristol-Myers Squibb United States Janssen-Cilag Farmaceutica Ltda Brazil Zentiva, k.s Czech Republic Janssen Ortho Puerto Rico Sandoz Switzerland Zydus Lifesciences India Mylan Dublin Ireland Viatris United States Krka Slovenia Krka Slovenia Teva Israel

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

Who makes cobicistat?

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

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Also on this molecule

Shortages 1 Finished dose 11 Contract mfrs 0