Suppliers / Neolpharma

Neolpharma

Puerto Rico Updated 9 July 2026

Neolpharma is a finished-dose manufacturer based in Puerto Rico. It appears in 27 regulatory filings across 4 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), MINSA (CR) and COFEPRIS (MX). Its GMP standing is certified by COFEPRIS (MX) and MHRA (UK). Its most recent recorded inspection, by US FDA, closed on 1 April 2022 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
27
filings across 4 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 1 April 2022 VAI US FDA
  • 5 February 2019 VAI US FDA
  • 7 June 2017 VAI US FDA
  • 18 June 2015 VAI US FDA
  • 7 March 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
Azcapotzalco, Mexico Not on file
CAGUAS, Puerto Rico Not on file
CAGUAS, Puerto Rico Not on file
Caguas, United States 3009993897

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 18 None
MINSA (CR) 4 None
COFEPRIS (MX) 3 2
DIGEMAPS (DO) 2 None
MHRA (UK) None 1

Comparing suppliers?

Choose your molecules and target markets. Neolpharma comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was VAI, on 1 April 2022.

Sources on this page

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