Molecules / Gadobutrol / China

Gadobutrol API manufacturers in China

CAS 770691-21-9 ATC V08CA09 Updated 9 July 2026
13
China-based manufacturers with an active filing of 13 worldwide
Showing 7 of 13 China-based manufacturers This list is ranked on evidence. Placement cannot be purchased.

Ranked China-based API manufacturers

02

Anhui Poly Pharm

China
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF and one valid CEP for gadobutrol, filing since 2023. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 1 market.

US DMF
1 active
CEP
1 valid
Last FDA inspection
2025 · VAI
GMP recognised in
1 markets
03

Jiangsu Hengrui Pharmaceuticals

China
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for gadobutrol, filing since 2020. Its 2025 FDA inspection closed as VAI, and its GMP is recognised in 8 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
2025 · VAI
GMP recognised in
8 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
04

Sichuan Renan Pharmaceutical

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one valid CEP for gadobutrol, filing since 2025. Its 2025 FDA inspection closed as NAI.

US DMF
None on file
CEP
1 valid
Last FDA inspection
2025 · NAI
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
05

Beijing Beilu Pharmaceutical

China
Makes the APIFinished dose
Credentials confirmed against the regulator files on 25 July 2026

Holds one active US DMF for gadobutrol, filing since 2024. Its GMP is recognised in 5 markets.

US DMF
1 active
CEP
None on file
Last FDA inspection
Not established
GMP recognised in
5 markets
How this listing is sourced FDA, List of Drug Master Files
View profile
06

Suzhou Medinoah

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one valid CEP for gadobutrol, filing since 2025.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile
07

Weinan Manareco Pharmaceutical

China
Makes the API
Credentials confirmed against the regulator files on 25 July 2026

Holds one valid CEP for gadobutrol, filing since 2025.

US DMF
None on file
CEP
1 valid
Last FDA inspection
Not established
GMP recognised in
Not established
How this listing is sourced EDQM certificate database
View profile

6 more manufacturers in China hold filings for gadobutrol

The names are listed below. The filings, inspection history and GMP certificates behind each one are available with a free account.

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How this list is built

This page filters the worldwide Gadobutrol manufacturer list to companies based in China. 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. Read the full method.

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