Suppliers / Galephar Pharmaceutical Research

Galephar Pharmaceutical Research

United States 73 employees Updated 9 July 2026

Galephar Pharmaceutical Research is a finished-dose manufacturer based in United States. It appears in 6 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), MINSA (CR) and Health Canada. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 5 June 2025 as NAI.

0
active US DMFs
0
valid CEPs
3
registered plants 2 with an FDA FEI number
6
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 5 June 2025 NAI US FDA
  • 18 October 2024 VAI US FDA
  • 1 November 2019 VAI US FDA
  • 23 November 2015 VAI US FDA
  • 11 June 2015 NAI US FDA
  • 15 January 2013 NAI US FDA
  • 7 May 2012 VAI US FDA
  • 29 September 2011 VAI US FDA

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

Registered plants

Site FDA FEI
JUNCOS, United States Not on file
Juncos, United States 3003068480
Humacao, United States 3008206797

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 3 None
MINSA (CR) 2 None
Health Canada 1 None
US FDA None 2

Questions about Galephar Pharmaceutical Research

Does Galephar Pharmaceutical Research hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Galephar Pharmaceutical Research. It does have 6 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Galephar Pharmaceutical Research FDA-registered?
2 sites operated by Galephar Pharmaceutical Research carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Galephar Pharmaceutical Research's last inspection go?
The most recent inspection on record closed on 5 June 2025 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Galephar Pharmaceutical Research manufacture?
3 registered sites are on record, in United States (Juncos, Juncos and Humacao). Every site is listed on this page with the register it came from.
Which regulators recognise Galephar Pharmaceutical Research'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 NAI, on 5 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