Suppliers / Aiac International Pharma

Aiac International Pharma

Puerto Rico Updated 9 July 2026

Aiac International Pharma is a finished-dose manufacturer based in Puerto Rico. It appears in 15 regulatory filings across 5 regulators, without an active US DMF or CEP on file. Its filings concentrate with NPRA (MY), INVIMA (CO) and MINSA (CR). Its GMP standing is certified by MFDS (Korea) and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 23 March 2021 as NAI.

0
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
15
filings across 5 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 23 March 2021 NAI US FDA
  • 1 June 2018 VAI US FDA
  • 17 August 2015 VAI US FDA
  • 24 January 2013 VAI US FDA
  • 14 April 2011 VAI US FDA
  • 3 November 2010 VAI US FDA

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

Registered plants

Site FDA FEI
ARECIBO, Puerto Rico Not on file
Arecibo, United States 3011580268

Filings and GMP by regulator

Regulator Filings GMP certificates
NPRA (MY) 6 None
INVIMA (CO) 3 None
MINSA (CR) 3 None
ARCSA (EC) 2 None
NCELS (KZ) 1 None
MFDS (Korea) None 2
ANVISA (Brazil) None 1

Questions about Aiac International Pharma

Does Aiac International Pharma hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Aiac International Pharma. It does have 15 filings with 5 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Aiac International Pharma FDA-registered?
One site operated by Aiac International Pharma 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 Aiac International Pharma's last inspection go?
The most recent inspection on record closed on 23 March 2021 as NAI (No Action Indicated: nothing objectionable was found). 6 inspections are on file.
Where does Aiac International Pharma manufacture?
2 registered sites are on record, in Puerto Rico and United States (Arecibo and Arecibo). Every site is listed on this page with the register it came from.
Which regulators recognise Aiac International Pharma's GMP?
Current GMP certificates are on record from MFDS (Korea) and ANVISA (Brazil). 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 23 March 2021.

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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