Lek

Poland 2 duplicate records merged Updated 9 July 2026

The public registers hold a second record for Lek. The fuller profile, with 26 active US DMFs and 10 valid CEPs, is at Lek Pharmaceuticals. Figures on this page cover only this record.

Lek is a finished-dose manufacturer based in Poland. It appears in 73 regulatory filings across 8 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), RCETH (BY) and MINSA (CR). Its GMP standing is certified by EMA, NCELS (KZ) and NAFDAC (NG), among 5 authorities. Its most recent recorded inspection, by US FDA, closed on 26 July 2024 as NAI.

active US DMFs

valid CEPs

registered plants 2 with an FDA FEI number

filings across 8 regulators

These figures were checked against the regulators' own files on 25 July 2026

Plants

2 of 2 confirmed

Inspections

8 of 8 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

26 July 2024 NAI US FDA
11 December 2023 NAI US FDA
24 November 2022 VAI US FDA
18 March 2022 VAI US FDA
30 August 2019 NAI US FDA
24 February 2017 VAI US FDA
25 September 2015 NAI US FDA
30 June 2015 VAI US FDA

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

Registered plants

Site	FDA FEI
strykow, United Arab Emirates	Not on file
Podlipie Street 95 Strykow Poland, Nigeria	Not on file
STRYKÓW, Poland	Not on file
Strykow, Poland	Not on file
Warszawa, Poland	Not on file
Slovenia, Slovenia	3002807460

1 further sites are on record.

Filings and GMP by regulator

Regulator	Filings	GMP certificates
ARCSA (EC)	20	None
RCETH (BY)	18	None
MINSA (CR)	16	None
NAFDAC (NG)	11	2
NCELS (KZ)	3	4
ANPP (DZ)	2	None
EMA	None	8
US FDA	None	1
ANVISA (Brazil)	None	1

Questions about Lek

Does Lek hold a US DMF or a CEP?

No active US drug master file or valid CEP is on record for Lek. It does have 73 filings with 8 regulators, so it is registered, just not with the two strong registers buyers usually screen on.

Is Lek FDA-registered?

2 sites operated by Lek 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 Lek's last inspection go?

The most recent inspection on record closed on 26 July 2024 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.

Where does Lek manufacture?

7 registered sites are on record, in United Arab Emirates, Nigeria, Poland and Slovenia (Strykow, Podlipie Street 95 Strykow Poland and Stryków among others). Every site is listed on this page with the register it came from.

Which regulators recognise Lek's GMP?

Current GMP certificates are on record from EMA, NCELS (KZ), NAFDAC (NG), US FDA 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 26 July 2024.

Comparable suppliers

Delpharm Poznan also in Poland Pharmaceutical Works Polpharma also in Poland Steriscience also in Poland Ifotam also in Poland Polfa Tarchomin also in Poland

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