Ranked API manufacturers
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs and one valid CEP for zopiclone, filing since 2007. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 10 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
10 markets
02 Italy
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for zopiclone, filing since 2000. 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
03 France
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for zopiclone, filing since 2024. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 17 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
17 markets
Holds 2 active US DMFs for zopiclone, filing since 2015. 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 active US DMF for zopiclone, filing since 2008.
Last FDA inspection
Not established
GMP recognised in
Not established
06 India
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for zopiclone, filing since 2001. Its 2024 FDA inspection closed as OAI, and its GMP is recognised in 1 market.
Last FDA inspection
2024 · OAI
GMP recognised in
1 markets
07 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for zopiclone. 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 zopiclone. 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 09 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for zopiclone. 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 10 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for zopiclone. 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 7 more manufacturers hold filings for zopiclone
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 Contract manufacturers (1)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (65)
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.