Renaissance Lakewood
United States Updated 9 July 2026
Renaissance Lakewood is a finished-dose manufacturer based in United States. It appears in 4 regulatory filings across 4 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), EDE (AE) and DIGEMAPS (DO). Its GMP standing is certified by US FDA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 6 June 2023 as VAI.
3
registered plants
1 with an FDA FEI number
4
filings
across 4 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 6 June 2023 VAI US FDA
- 22 August 2019 VAI US FDA
- 15 March 2018 VAI US FDA
- 26 April 2017 NAI US FDA
- 1 June 2016 NAI US FDA
- 6 February 2015 VAI US FDA
- 4 November 2014 NAI US FDA
- 17 January 2013 NAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Lakewood, United Arab Emirates | Not on file |
| NEW JERSEY, United States | Not on file |
| Lakewood, United States | 2242829 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| ARCSA (EC) | 1 | None |
| EDE (AE) | 1 | None |
| DIGEMAPS (DO) | 1 | None |
| NPRA (MY) | 1 | None |
| US FDA | None | 1 |
| ANVISA (Brazil) | None | 1 |
Comparing suppliers?
Choose your molecules and target markets. Renaissance Lakewood comes back tiered against every other
supplier able to file there.
Start for free No sales call.
Open risk flags
- The most recent inspection outcome was VAI, on 6 June 2023.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates