Suppliers / Advance Pharmaceutical

Advance Pharmaceutical

United States 3 duplicate records merged Updated 9 July 2026

Advance Pharmaceutical is a finished-dose manufacturer based in United States. It appears in 259 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with DH (HK) and NMPA (CN). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 27 February 2025 as VAI.

0
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
259
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 27 February 2025 VAI US FDA
  • 13 December 2018 VAI US FDA
  • 6 July 2017 VAI US FDA
  • 2 December 2015 OAI US FDA
  • 6 March 2015 VAI US FDA
  • 19 December 2013 VAI US FDA
  • 2 July 2013 OAI US FDA
  • 11 January 2013 VAI US FDA

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

Registered plants

Site FDA FEI
Holtsville, United States 2434807

Filings and GMP by regulator

Regulator Filings GMP certificates
DH (HK) 255 None
NMPA (CN) 4 None
US FDA None 1

Questions about Advance Pharmaceutical

Does Advance Pharmaceutical hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Advance Pharmaceutical. It does have 259 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Advance Pharmaceutical FDA-registered?
One site operated by Advance 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 Advance Pharmaceutical's last inspection go?
The most recent inspection on record closed on 27 February 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file, of which 2 closed as OAI.
Where does Advance Pharmaceutical manufacture?
1 registered site is on record, in United States (Holtsville). Every site is listed on this page with the register it came from.
Which regulators recognise Advance 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 27 February 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