Ranked API manufacturers
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and 2 valid CEPs for xylometazoline, filing since 1991. Its 2023 FDA inspection closed as VAI.
Last FDA inspection
2023 · VAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Holds one active US DMF and one valid CEP for xylometazoline, filing since 2024. 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
Credentials confirmed against the regulator files on 25 July 2026
Holds one valid CEP for xylometazoline, filing since 2020. 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 valid CEP for xylometazoline, filing since 2022. Its 2025 FDA inspection closed as VAI.
Last FDA inspection
2025 · VAI
GMP recognised in
Not established
Registered with DAV (Vietnam) for xylometazoline. 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 06 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for xylometazoline. 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 07 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for xylometazoline. 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 08 Vietnam
Makes the APIFinished dose
Registered with DAV (Vietnam) for xylometazoline. 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 xylometazoline. 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 xylometazoline. 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 xylometazoline
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 (3)
Contract manufacturers make to order rather than holding their own filing for this
molecule.
Finished-dose makers (63)
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.