Ranked API manufacturers
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for simvastatin, filing since 2013. 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
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and 2 valid CEPs for simvastatin, filing since 2005. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 29 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
29 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and 2 valid CEPs for simvastatin, filing since 2004. 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
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and 2 valid CEPs for simvastatin, filing since 2013. Its 2023 FDA inspection closed as NAI.
Last FDA inspection
2023 · NAI
GMP recognised in
Not established
05 Israel
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for simvastatin, filing since 1999. Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 42 markets.
Last FDA inspection
2024 · NAI
GMP recognised in
42 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and 2 valid CEPs for simvastatin, filing since 2018. 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 and 2 valid CEPs for simvastatin, filing since 2024.
Last FDA inspection
Not established
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for simvastatin, filing since 2024. Its GMP is recognised in 4 markets.
Last FDA inspection
Not established
GMP recognised in
4 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 3 valid CEPs for simvastatin, filing since 2025. Its 2024 FDA inspection closed as NAI.
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
Holds 2 active US DMFs for simvastatin, filing since 2005. Its 2022 FDA inspection closed as VAI.
Last FDA inspection
2022 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for simvastatin, filing since 2024.
Last FDA inspection
Not established
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for simvastatin, filing since 2021. Its GMP is recognised in 1 market.
Last FDA inspection
Not established
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for simvastatin, filing since 2006.
Last FDA inspection
Not established
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for simvastatin, filing since 2009.
Last FDA inspection
Not established
GMP recognised in
Not established
15 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for simvastatin. 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 16 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for simvastatin. 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 Registered with PMDA (Japan) for simvastatin.
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 18 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for simvastatin. Its GMP is recognised in 2 markets.
Last FDA inspection
Not established
GMP recognised in
2 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 19 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for simvastatin. 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 20 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for simvastatin. 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 21 more manufacturers hold filings for simvastatin
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 (3)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (173)
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.