Suppliers / Hubei Biocause Heilen Pharmaceutical

Hubei Biocause Heilen Pharmaceutical

China Updated 9 July 2026

Hubei Biocause Heilen Pharmaceutical is an API manufacturer based in China. It holds 16 active US drug master files and 5 valid CEPs across a filed portfolio of 14 molecules. Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 14 November 2025 as VAI.

16
active US DMFs
5
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
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 14 November 2025 VAI US FDA
  • 16 August 2019 VAI US FDA
  • 22 November 2013 NAI US FDA
  • 4 March 2009 NAI US FDA

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

Registered plants

Site FDA FEI
Jingmen City, China Not on file
Jingmen City, China Not on file
China, China 3007268407

What they file, and where

Molecule Regulators Docs
Ibuprofen EDQM, SFDA (Saudi Arabia), US FDA 4
Fludarabine EDQM, US FDA 3
Abiraterone SFDA (Saudi Arabia), US FDA 2
Cladribine EDQM, US FDA 2
Dexibuprofen SFDA (Saudi Arabia), US FDA 2
Dexmedetomidine US FDA 2
Granisetron EDQM, US FDA 2
Atropine US FDA 1
Flumazenil US FDA 1
Homatropine US FDA 1
Show all 14 molecules on file
Homatropine Methylbromide US FDA 1
Hyoscyamine US FDA 1
Milrinone US FDA 1
Torasemide EDQM 1

Also appears on these molecule pages

Abiraterone contract manufacturing Arginine contract manufacturing Atropine contract manufacturing Carfilzomib contract manufacturing Cladribine contract manufacturing Dexibuprofen contract manufacturing Dexmedetomidine API Flumazenil contract manufacturing Granisetron contract manufacturing Ibuprofen contract manufacturing Milrinone contract manufacturing Torasemide contract manufacturing

Filings and GMP by regulator

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

Questions about Hubei Biocause Heilen Pharmaceutical

Does Hubei Biocause Heilen Pharmaceutical hold a US DMF or a CEP?
Hubei Biocause Heilen Pharmaceutical holds 16 active US drug master files and 5 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 Hubei Biocause Heilen Pharmaceutical FDA-registered?
One site operated by Hubei Biocause Heilen 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 Hubei Biocause Heilen Pharmaceutical's last inspection go?
The most recent inspection on record closed on 14 November 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Hubei Biocause Heilen Pharmaceutical manufacture?
3 registered sites are on record, in China (Jingmen City and China among others). Every site is listed on this page with the register it came from.
What does Hubei Biocause Heilen Pharmaceutical make?
14 molecules are on record against Hubei Biocause Heilen Pharmaceutical, including Ibuprofen, Fludarabine, Abiraterone and Cladribine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Hubei Biocause Heilen Pharmaceutical's GMP?
Current GMP certificates are on record from MFDS (Korea) 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 VAI, on 14 November 2025.

Comparable suppliers

ScinoPharm Taiwan shares 3 molecules Wuhan Biocause Pharmaceutical Development shares 3 molecules MSN Laboratories shares 2 molecules Apitoria Pharma shares 2 molecules Hetero shares 2 molecules

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