Suppliers / Sichuan Renan Pharmaceutical

Sichuan Renan Pharmaceutical

China Updated 9 July 2026

Sichuan Renan Pharmaceutical is an API manufacturer based in China. It holds 2 valid CEPs across a filed portfolio of 2 molecules. Its GMP standing is certified by MFDS (Korea), EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 21 March 2025 as NAI.

0
active US DMFs
2
valid CEPs
3
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
1 of 1 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 21 March 2025 NAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Yuechi, China Not on file
Guangan, China Not on file
China, China 3016946731

What they file, and where

Molecule Regulators Docs
Gadobutrol EDQM 1
Nicergoline EDQM 1

Also appears on these molecule pages

Gadobutrol API

Filings and GMP by regulator

Regulator Filings GMP certificates
MFDS (Korea) None 4
EMA None 4
US FDA None 1

Questions about Sichuan Renan Pharmaceutical

Does Sichuan Renan Pharmaceutical hold a US DMF or a CEP?
Sichuan Renan Pharmaceutical holds 2 valid CEPs. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Sichuan Renan Pharmaceutical FDA-registered?
One site operated by Sichuan Renan Pharmaceutical carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Sichuan Renan Pharmaceutical's last inspection go?
The most recent inspection on record closed on 21 March 2025 as NAI (No Action Indicated: nothing objectionable was found). 1 inspection is on file.
Where does Sichuan Renan Pharmaceutical manufacture?
3 registered sites are on record, in China (Yuechi, Guangan and China). Every site is listed on this page with the register it came from.
What does Sichuan Renan Pharmaceutical make?
2 molecules are on record against Sichuan Renan Pharmaceutical, including Gadobutrol and Nicergoline. Each links through to that molecule's full manufacturer list.
Which regulators recognise Sichuan Renan Pharmaceutical's GMP?
Current GMP certificates are on record from MFDS (Korea), EMA and US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • The most recent inspection outcome was NAI, on 21 March 2025.

Comparable suppliers

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates