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 city, China Not on file
Tianmen, 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

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Open risk flags

  • The most recent inspection outcome was VAI, on 13 December 2024.

Sources on this page

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