Suppliers / Hubei Yitai Pharmaceutical

Hubei Yitai Pharmaceutical

China Updated 9 July 2026

Hubei Yitai Pharmaceutical is an API manufacturer based in China. It holds 3 active US drug master files and 4 valid CEPs across a filed portfolio of 2 molecules. Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 13 December 2024 as VAI.

3
active US DMFs
4
valid CEPs
3
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

  • 13 December 2024 VAI US FDA
  • 22 September 2016 VAI US FDA

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

Registered plants

Site FDA FEI
Tianmen, China Not on file
Tianmen city, China Not on file
China, China 3004844161

What they file, and where

Molecule Regulators Docs
Clindamycin EDQM, US FDA 5
Acyclovir EDQM, US FDA 2

Also appears on these molecule pages

Acyclovir API Clindamycin API

Filings and GMP by regulator

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

Questions about Hubei Yitai Pharmaceutical

Does Hubei Yitai Pharmaceutical hold a US DMF or a CEP?
Hubei Yitai Pharmaceutical holds 3 active US drug master files and 4 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 Yitai Pharmaceutical FDA-registered?
One site operated by Hubei Yitai 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 Yitai Pharmaceutical's last inspection go?
The most recent inspection on record closed on 13 December 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Hubei Yitai Pharmaceutical manufacture?
3 registered sites are on record, in China (Tianmen, Tianmen City and China). Every site is listed on this page with the register it came from.
What does Hubei Yitai Pharmaceutical make?
2 molecules are on record against Hubei Yitai Pharmaceutical, including Clindamycin and Acyclovir. Each links through to that molecule's full manufacturer list.
Which regulators recognise Hubei Yitai 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 13 December 2024.

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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