Ranked API manufacturers
01 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for emtricitabine, filing since 2008. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 23 markets.
Last FDA inspection
2025 · NAI
GMP recognised in
23 markets
02 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for emtricitabine, filing since 2011. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
29 markets
03 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for emtricitabine, filing since 2010. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 13 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
13 markets
04 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for emtricitabine, filing since 2009. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 30 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
30 markets
05 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for emtricitabine, filing since 2006. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 34 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
34 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for emtricitabine, filing since 2007. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for emtricitabine, filing since 2011. Its 2023 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2023 · VAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for emtricitabine, filing since 2019. Its 2024 FDA inspection closed as VAI.
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds 3 active US DMFs for emtricitabine, filing since 2006. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for emtricitabine, filing since 2025. Its 2024 FDA inspection closed as VAI.
Last FDA inspection
2024 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for emtricitabine, filing since 2017.
Last FDA inspection
Not established
GMP recognised in
Not established
Registered with SFDA (Saudi Arabia) for emtricitabine. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2022 · VAI
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile Registered with SFDA (Saudi Arabia) for emtricitabine.
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 14 South Korea
Makes the API
Registered with SFDA (Saudi Arabia) for emtricitabine. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile Registered with PMDA (Japan) for emtricitabine.
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 16 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for emtricitabine. Its GMP is recognised in 1 market.
Last FDA inspection
Not established
GMP recognised in
1 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 13 more manufacturers hold filings for emtricitabine
The names are listed below. The filings, inspection history and GMP certificates behind
each one are available with a free account.
Open the full list with a free account Contract manufacturers (2)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (36)
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.