Ranked API manufacturers
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and 2 valid CEPs for oxybutynin, filing since 2009. Its 2025 FDA inspection closed as NAI, and its GMP is recognised in 3 markets.
Last FDA inspection
2025 · NAI
GMP recognised in
3 markets
02 Switzerland
Makes the API
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for oxybutynin, filing since 1996. 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 one valid CEP for oxybutynin, filing since 2022. 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
Credentials confirmed against the regulator files on 25 July 2026
Holds 2 active US DMFs for oxybutynin, filing since 1986. Its 2022 FDA inspection closed as VAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2022 · VAI
GMP recognised in
2 markets
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF for oxybutynin, 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 oxybutynin, filing since 1997. 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 2 active US DMFs for oxybutynin, filing since 2010. 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 valid CEP for oxybutynin, filing since 2025. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 3 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
3 markets
5 more manufacturers hold filings for oxybutynin
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 (2)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (30)
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 2024. These are export values rather than
contract prices for regulated-market grade material, which are higher.