Suppliers / Nordmark Pharma

Nordmark Pharma

Germany 249 employees Updated 9 July 2026

Nordmark Pharma is a finished-dose manufacturer based in Germany. It holds 3 active US drug master files and 2 valid CEPs across a filed portfolio of 4 molecules. Its filings concentrate with EMA and FAMHP (BE). Its GMP standing is certified by ZLG (DE), EMA and MFDS (Korea), among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 13 February 2025 as VAI.

3
active US DMFs
2
valid CEPs
3
registered plants 1 with an FDA FEI number
16
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 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

  • 13 February 2025 VAI US FDA
  • 31 August 2023 VAI US FDA
  • 16 August 2019 VAI US FDA
  • 17 February 2017 VAI US FDA
  • 20 November 2014 VAI US FDA
  • 29 November 2012 VAI US FDA
  • 26 February 2010 VAI US FDA
  • 9 April 2009 VAI US FDA

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

Registered plants

Site FDA FEI
Germany, Germany 3003293533
Uetersen, Germany Not on file
Schleswig-Holstein, Germany Not on file

What they file, and where

Molecule Regulators Docs
Collagenase Clostridium Histolyticum US FDA 2
Collagenase N EDQM 1
Pancreas Powder EDQM 1
Pancrelipase US FDA 1

Also appears on these molecule pages

Heparin finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 14 2
FAMHP (BE) 2 None
ZLG (DE) None 8
MFDS (Korea) None 2
US FDA None 1

Questions about Nordmark Pharma

Does Nordmark Pharma hold a US DMF or a CEP?
Nordmark Pharma holds 3 active US drug master files and 2 valid CEPs. 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 Nordmark Pharma FDA-registered?
One site operated by Nordmark 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 Nordmark Pharma's last inspection go?
The most recent inspection on record closed on 13 February 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Nordmark Pharma manufacture?
3 registered sites are on record, in Germany (Germany, Uetersen and Schleswig-holstein). Every site is listed on this page with the register it came from.
What does Nordmark Pharma make?
4 molecules are on record against Nordmark Pharma, including Collagenase Clostridium Histolyticum, Collagenase N, Pancreas Powder and Pancrelipase. Each links through to that molecule's full manufacturer list.
Which regulators recognise Nordmark Pharma's GMP?
Current GMP certificates are on record from ZLG (DE), EMA, MFDS (Korea) and US FDA. 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 13 February 2025.

Comparable suppliers

Laborchemie Apolda also in Germany Peptido also in Germany Boehringer Ingelheim Pharma Gmbh also in Germany Dynamit Nobel GmbH Explosivstoff- und Systemtechnik also in Germany Kd Pharma Bexbach also in Germany

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