Suppliers / Renaissance Lakewood

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.

0
active US DMFs
0
valid CEPs
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
Plants
1 of 1 confirmed
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

Questions about Renaissance Lakewood

Does Renaissance Lakewood hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Renaissance Lakewood. It does have 4 filings with 4 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Renaissance Lakewood FDA-registered?
One site operated by Renaissance Lakewood 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 Renaissance Lakewood's last inspection go?
The most recent inspection on record closed on 6 June 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Renaissance Lakewood manufacture?
3 registered sites are on record, in United Arab Emirates and United States (Lakewood and NEW Jersey among others). Every site is listed on this page with the register it came from.
Which regulators recognise Renaissance Lakewood's GMP?
Current GMP certificates are on record from 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 VAI, on 6 June 2023.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates