Suppliers / Sunshine Lake Pharma

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.

0
active US DMFs
0
valid CEPs
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
Plants
1 of 1 confirmed
Inspections
5 of 5 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

  • 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

Questions about Sunshine Lake Pharma

Does Sunshine Lake Pharma hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Sunshine Lake Pharma. It does have 6 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Sunshine Lake Pharma FDA-registered?
One site operated by Sunshine Lake Pharma 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 Sunshine Lake Pharma's last inspection go?
The most recent inspection on record closed on 22 March 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file, of which 1 closed as OAI.
Where does Sunshine Lake Pharma manufacture?
2 registered sites are on record, in China (Dongguan and China). Every site is listed on this page with the register it came from.
Which regulators recognise Sunshine Lake Pharma's GMP?
Current GMP certificates are on record from 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 VAI, on 22 March 2024.

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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