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

Questions about Neolpharma

Does Neolpharma hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Neolpharma. It does have 27 filings with 4 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Neolpharma FDA-registered?
One site operated by Neolpharma 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 Neolpharma's last inspection go?
The most recent inspection on record closed on 1 April 2022 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Neolpharma manufacture?
4 registered sites are on record, in Mexico, Puerto Rico and United States (Azcapotzalco, Caguas and Caguas among others). Every site is listed on this page with the register it came from.
Which regulators recognise Neolpharma's GMP?
Current GMP certificates are on record from COFEPRIS (MX) and MHRA (UK). 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 1 April 2022.

Comparable suppliers

Aiac International Pharma also in Puerto Rico Janssen-Cilag Manufacturing also in Puerto Rico Janssen Ortho also in Puerto Rico Lilly Del Caribe also in Puerto Rico

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
EudraGMDP and national regulators
GMP certificates