Ranked API manufacturers
Credentials confirmed against the regulator files on 25 July 2026
Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 8 markets.
Last FDA inspection
2025 · VAI
GMP recognised in
8 markets
Its 2024 FDA inspection closed as NAI.
Last FDA inspection
2024 · NAI
GMP recognised in
Not established
Credentials confirmed against the regulator files on 25 July 2026
Its 2024 FDA inspection closed as NAI, and its GMP is recognised in 2 markets.
Last FDA inspection
2024 · NAI
GMP recognised in
2 markets
Credentials confirmed against the regulator files on 25 July 2026
Its GMP is recognised in 5 markets.
Last FDA inspection
Not established
GMP recognised in
5 markets
Credentials confirmed against the regulator files on 25 July 2026
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
06 Norway
Makes the APIFinished dose
Registered with SFDA (Saudi Arabia) for gadoteric acid. Its 2024 FDA inspection closed as VAI, and its GMP is recognised in 21 markets.
Last FDA inspection
2024 · VAI
GMP recognised in
21 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
Credentials confirmed against the regulator files on 25 July 2026
Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
08 Austria
Makes the APIFinished dose
Registered with SFDA (Saudi Arabia) for gadoteric acid. Its GMP is recognised in 13 markets.
Last FDA inspection
Not established
GMP recognised in
13 markets
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile
Credentials confirmed against the regulator files on 25 July 2026
Last FDA inspection
Not established
GMP recognised in
Not established
Registered with SFDA (Saudi Arabia) for gadoteric acid.
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 SFDA (Saudi Arabia) for gadoteric acid.
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced Regulator filings, warehouse snapshot 9 July 2026
View profile 8 more manufacturers hold filings for gadoteric acid
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 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