Suppliers / SmartPractice Denmark ApS

SmartPractice Denmark ApS

Denmark 28 employees Updated 9 July 2026

SmartPractice Denmark ApS is a finished-dose manufacturer based in Denmark. It appears in 206 regulatory filings across 9 regulators, without an active US DMF or CEP on file. Its filings concentrate with EMA, AIFA (IT) and MPA (SE). Its GMP standing is certified by ZLG (DE), EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 16 August 2024 as NAI.

0
active US DMFs
0
valid CEPs
4
registered plants 1 with an FDA FEI number
206
filings across 9 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 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

  • 16 August 2024 NAI US FDA
  • 5 April 2019 VAI US FDA
  • 29 January 2016 VAI US FDA
  • 28 January 2014 VAI US FDA
  • 11 November 2011 VAI US FDA
  • 17 September 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
Greven, Germany Not on file
North Rhine-Westphalia, Germany Not on file
Denmark, Denmark 3003216248
Hilleroed, Denmark Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 179 3
AIFA (IT) 9 None
MPA (SE) 4 None
DMP (NO) 3 None
BFARM (DE) 3 None
AEMPS (ES) 3 None
ZLG (DE) None 6
US FDA None 1

Questions about SmartPractice Denmark ApS

Does SmartPractice Denmark ApS hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for SmartPractice Denmark ApS. It does have 206 filings with 9 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is SmartPractice Denmark ApS FDA-registered?
One site operated by SmartPractice Denmark ApS 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 SmartPractice Denmark ApS's last inspection go?
The most recent inspection on record closed on 16 August 2024 as NAI (No Action Indicated: nothing objectionable was found). 6 inspections are on file.
Where does SmartPractice Denmark ApS manufacture?
4 registered sites are on record, in Germany and Denmark (Greven, North Rhine-westphalia and Denmark among others). Every site is listed on this page with the register it came from.
Which regulators recognise SmartPractice Denmark ApS's GMP?
Current GMP certificates are on record from ZLG (DE), EMA 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 NAI, on 16 August 2024.

Comparable suppliers

Novo Nordisk A/S also in Denmark Danipharm A/S also in Denmark H. Lundbecks A/S also in Denmark Syntese A/S also in Denmark Fertin Pharma A/S also in Denmark

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