Ranked API manufacturers
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for pitavastatin, filing since 2010. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 26 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
26 markets
02 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for pitavastatin, filing since 2013. 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 for pitavastatin, filing since 2013. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 6 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
6 markets
04 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for pitavastatin, filing since 2013. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 25 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
25 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for pitavastatin, filing since 2000. 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 pitavastatin, filing since 2012. Its 2026 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2026 · VAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for pitavastatin, filing since 2013. 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 pitavastatin, filing since 2025. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2024 · VAI
GMP recognised in
1 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for pitavastatin, filing since 2013. 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 pitavastatin, filing since 2017. 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 one active US DMF for pitavastatin, filing since 2019. Its GMP is recognised in 1 market.
Last FDA inspection
Not established
GMP recognised in
1 markets
12 South Korea
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for pitavastatin, filing since 2018.
Last FDA inspection
Not established
GMP recognised in
Not established
Registered with SFDA (Saudi Arabia) for pitavastatin.
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile Registered with DAV (Vietnam) for pitavastatin. 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 DAV (Vietnam) for pitavastatin. 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 12 more manufacturers hold filings for pitavastatin
The names are listed below. Ask Fred about the filings, inspection history and GMP
certificates on record for each manufacturer.
Chat with Fred, your AI analyst Finished-dose makers (34)
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.