Suppliers / Hebei Huarong Pharmaceutical

Hebei Huarong Pharmaceutical

China Updated 9 July 2026

Hebei Huarong Pharmaceutical is an API manufacturer based in China. It holds 7 active US drug master files and 3 valid CEPs across a filed portfolio of 5 molecules. Its GMP standing is certified by MFDS (Korea).

7
active US DMFs
3
valid CEPs
3
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
Sources: FDA Establishment Registration, read 4 May 2026.

Registered plants

Site FDA FEI
Shijiazhuang, China Not on file
Xingtai, China Not on file
China, China 3015243991

What they file, and where

Molecule Regulators Docs
Hydroxocobalamin EDQM, US FDA 4
Cyanocobalamin EDQM, US FDA 2
Mecobalamin US FDA 2
Acarbose US FDA 1
Cobamamide US FDA 1

Also appears on these molecule pages

Acarbose API Mecobalamin API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 2 None
MFDS (Korea) None 2

Questions about Hebei Huarong Pharmaceutical

Does Hebei Huarong Pharmaceutical hold a US DMF or a CEP?
Hebei Huarong Pharmaceutical holds 7 active US drug master files and 3 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 Hebei Huarong Pharmaceutical FDA-registered?
One site operated by Hebei Huarong 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.
Where does Hebei Huarong Pharmaceutical manufacture?
3 registered sites are on record, in China (Shijiazhuang, Xingtai and China). Every site is listed on this page with the register it came from.
What does Hebei Huarong Pharmaceutical make?
5 molecules are on record against Hebei Huarong Pharmaceutical, including Hydroxocobalamin, Cyanocobalamin, Mecobalamin and Acarbose. Each links through to that molecule's full manufacturer list.
Which regulators recognise Hebei Huarong Pharmaceutical's GMP?
Current GMP certificates are on record from MFDS (Korea). 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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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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