Suppliers / Chongqing Biocare Pharmaceutical

Chongqing Biocare Pharmaceutical

China Updated 9 July 2026

Chongqing Biocare Pharmaceutical is an API manufacturer based in China. It holds one active US drug master file across a filed portfolio of 3 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 22 September 2023 as VAI.

1
active US DMFs
0
valid CEPs
1
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
2 of 2 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 22 September 2023 VAI US FDA
  • 28 April 2016 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 3006305268

What they file, and where

Molecule Regulators Docs
Chlorothiazide SFDA (Saudi Arabia) 1
Clindamycin US FDA 1
Eribulin Mesilate SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Chongqing Biocare Pharmaceutical

Does Chongqing Biocare Pharmaceutical hold a US DMF or a CEP?
Chongqing Biocare Pharmaceutical holds 1 active US drug master file. 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 Chongqing Biocare Pharmaceutical FDA-registered?
One site operated by Chongqing Biocare 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 Chongqing Biocare Pharmaceutical's last inspection go?
The most recent inspection on record closed on 22 September 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Chongqing Biocare Pharmaceutical manufacture?
1 registered site is on record, in China (China). Every site is listed on this page with the register it came from.
What does Chongqing Biocare Pharmaceutical make?
3 molecules are on record against Chongqing Biocare Pharmaceutical, including Chlorothiazide, Clindamycin and Eribulin Mesilate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Chongqing Biocare Pharmaceutical's GMP?
Current GMP certificates are on record from 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 22 September 2023.

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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