Suppliers / Olpha

Olpha

Latvia 361 employees 2 duplicate records merged Updated 9 July 2026

Olpha is an API and finished-dose manufacturer based in Latvia. It holds 4 active US drug master files across a filed portfolio of 4 molecules. Its filings concentrate with AIFA (IT), AEMPS (ES) and EMA. Its GMP standing is certified by EAEU_EEC, US FDA and EMA, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 10 June 2024 as NAI.

4
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
336
filings across 9 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 10 June 2024 NAI US FDA
  • 13 September 2018 VAI US FDA
  • 19 September 2014 NAI US FDA
  • 4 March 2011 NAI US FDA

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

Registered plants

Site FDA FEI
Latvia, Latvia 3001672072

Filings and GMP by regulator

Regulator Filings GMP certificates
AIFA (IT) 203 None
AEMPS (ES) 65 None
EMA 45 1
MHRA (UK) 7 None
UZPHARM (UZ) 7 1
MPA (SE) 6 None
EAEU_EEC None 1
US FDA None 1

Questions about Olpha

Does Olpha hold a US DMF or a CEP?
Olpha holds 4 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Olpha FDA-registered?
One site operated by Olpha 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 Olpha's last inspection go?
The most recent inspection on record closed on 10 June 2024 as NAI (No Action Indicated: nothing objectionable was found). 4 inspections are on file.
Where does Olpha manufacture?
1 registered site is on record, in Latvia (Latvia). Every site is listed on this page with the register it came from.
What does Olpha make?
4 molecules are on record against Olpha, including Amantadine, Anagrelide, Memantine and Rimantadine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Olpha's GMP?
Current GMP certificates are on record from EEC (Eurasian Economic Union), US FDA, EMA and UZPHARM (UZ). 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 10 June 2024.

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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