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.
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
Inspections
6 of 6 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 |
| North Rhine-Westphalia, Germany | Not on file |
| Greven, 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 |
| AEMPS (ES) | 3 | None |
| BFARM (DE) | 3 | None |
| DMP (NO) | 3 | None |
| ZLG (DE) | None | 6 |
| US FDA | None | 1 |
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Open risk flags
- The most recent inspection outcome was NAI, on 16 August 2024.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates