Suppliers / Fortune Pharmacal

Fortune Pharmacal

Hong Kong 104 employees Updated 9 July 2026

Fortune Pharmacal is a finished-dose manufacturer based in Hong Kong. It appears in 42 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with DH (HK), NMPA (CN) and Health Canada. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 6 June 2025 as VAI.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
42
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 6 June 2025 VAI US FDA
  • 13 July 2018 VAI US FDA
  • 29 August 2014 VAI US FDA

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

Registered plants

Site FDA FEI
Hong Kong, Hong Kong 3003952755

Filings and GMP by regulator

Regulator Filings GMP certificates
DH (HK) 37 None
NMPA (CN) 4 None
Health Canada 1 None
US FDA None 1

Questions about Fortune Pharmacal

Does Fortune Pharmacal hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Fortune Pharmacal. It does have 42 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Fortune Pharmacal FDA-registered?
One site operated by Fortune Pharmacal 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 Fortune Pharmacal's last inspection go?
The most recent inspection on record closed on 6 June 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Fortune Pharmacal manufacture?
1 registered site is on record, in Hong Kong (Hong Kong). Every site is listed on this page with the register it came from.
Which regulators recognise Fortune Pharmacal'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 6 June 2025.

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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