Suppliers / Ruyuan Hec Pharm

Ruyuan Hec Pharm

China Updated 9 July 2026

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

Filings and GMP by regulator

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

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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