Sunshine Lake Pharma
China 2 duplicate records merged Updated 9 July 2026
Sunshine Lake Pharma is a finished-dose manufacturer based in China. It appears in 6 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with US FDA and ARCSA (EC). Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 22 March 2024 as VAI.
2
registered plants
1 with an FDA FEI number
6
filings
across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
5 of 5 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
- 22 March 2024 VAI US FDA
- 19 October 2017 VAI US FDA
- 25 September 2015 OAI US FDA
- 14 March 2014 NAI US FDA
- 21 April 2011 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Dongguan, China | Not on file |
| China, China | 3007721552 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | 5 | 1 |
| ARCSA (EC) | 1 | None |
| EMA | None | 1 |
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Open risk flags
- The most recent inspection outcome was VAI, on 22 March 2024.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates