Suppliers / Hunan KYF Pharmaceutical

Hunan KYF Pharmaceutical

China Updated 9 July 2026

Hunan KYF Pharmaceutical is an API manufacturer based in China. It holds 2 active US drug master files and one valid CEP across a filed portfolio of 3 molecules. Its most recent recorded inspection, by US FDA, closed on 16 August 2017 as NAI.

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

Inspection history

  • 16 August 2017 NAI US FDA

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

Registered plants

Site FDA FEI
Jinshi, China Not on file
China, China 3003657679

What they file, and where

Molecule Regulators Docs
Ethinylestradiol EDQM 1
Levonorgestrel US FDA 1
Norgestrel US FDA 1

Also appears on these molecule pages

Ethinylestradiol API Levonorgestrel API Norgestrel API

Questions about Hunan KYF Pharmaceutical

Does Hunan KYF Pharmaceutical hold a US DMF or a CEP?
Hunan KYF Pharmaceutical holds 2 active US drug master files and 1 valid CEP. 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 Hunan KYF Pharmaceutical FDA-registered?
One site operated by Hunan KYF 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 Hunan KYF Pharmaceutical's last inspection go?
The most recent inspection on record closed on 16 August 2017 as NAI (No Action Indicated: nothing objectionable was found). 1 inspection is on file.
Where does Hunan KYF Pharmaceutical manufacture?
2 registered sites are on record, in China (Jinshi and China). Every site is listed on this page with the register it came from.
What does Hunan KYF Pharmaceutical make?
3 molecules are on record against Hunan KYF Pharmaceutical, including Ethinylestradiol, Levonorgestrel and Norgestrel. Each links through to that molecule's full manufacturer list.

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 NAI, on 16 August 2017.

Comparable suppliers

Lupin shares 3 molecules “Gedeon Richter” shares 3 molecules Bayer S/A shares 3 molecules Industriale Chimica shares 2 molecules Valary Lab 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