Suppliers / Ruyuan Hec Pharm

Ruyuan Hec Pharm

China Updated 9 July 2026

The public registers hold a second record for Ruyuan Hec Pharm. The fuller profile, with 43 active US DMFs and 4 valid CEPs, is at HEC Pharm. Figures on this page cover only this record.

Ruyuan Hec Pharm is an API manufacturer based in China. It holds 21 active US drug master files across a filed portfolio of 20 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 22 November 2024 as NAI.

21
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
2
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 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

  • 22 November 2024 NAI US FDA
  • 29 November 2019 VAI US FDA
  • 11 September 2015 NAI US FDA

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

Registered plants

Site FDA FEI
China, China 3009740510
Shaoguan City, Ruyuan County, Guangdong Province, China Not on file

What they file, and where

Molecule Regulators Docs
Sitagliptin SFDA (Saudi Arabia), US FDA 4
Fingolimod SFDA (Saudi Arabia), US FDA 2
Rosuvastatin US FDA 2
Alogliptin US FDA 1
Apixaban US FDA 1
Apremilast US FDA 1
Aripiprazole US FDA 1
Brivaracetam US FDA 1
Escitalopram US FDA 1
Linagliptin US FDA 1
Show all 20 molecules on file
Linagliptin And SFDA (Saudi Arabia) 1
Oseltamivir US FDA 1
Prasugrel US FDA 1
Ritonavir US FDA 1
Rivaroxaban US FDA 1
Sofosbuvir SFDA (Saudi Arabia) 1
Solifenacin Succinate US FDA 1
Sugammadex US FDA 1
Tadalafil US FDA 1
Vonoprazan US FDA 1

Also appears on these molecule pages

Show 7 more molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 2 None
EMA None 1
US FDA None 1

Questions about Ruyuan Hec Pharm

Does Ruyuan Hec Pharm hold a US DMF or a CEP?
Ruyuan Hec Pharm holds 21 active US drug master files. 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 Ruyuan Hec Pharm FDA-registered?
One site operated by Ruyuan Hec Pharm 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 Ruyuan Hec Pharm's last inspection go?
The most recent inspection on record closed on 22 November 2024 as NAI (No Action Indicated: nothing objectionable was found). 3 inspections are on file.
Where does Ruyuan Hec Pharm manufacture?
2 registered sites are on record, in China (China and Shaoguan City, Ruyuan County, Guangdong Province). Every site is listed on this page with the register it came from.
What does Ruyuan Hec Pharm make?
20 molecules are on record against Ruyuan Hec Pharm, including Sitagliptin, Fingolimod, Rosuvastatin and Alogliptin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Ruyuan Hec Pharm's GMP?
Current GMP certificates are on record from 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

  • 3 active litigation matters are on record.
  • The most recent inspection outcome was NAI, on 22 November 2024.

Sources on this page

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