Suppliers / Changzhou Sunlight Pharmaceutical

Changzhou Sunlight Pharmaceutical

China Updated 9 July 2026

Changzhou Sunlight Pharmaceutical is a contract manufacturer based in China. It holds one valid CEP. Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 31 May 2024 as VAI.

0
active US DMFs
1
valid CEPs
3
registered plants 1 with an FDA FEI number
2
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 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

  • 31 May 2024 VAI US FDA
  • 22 September 2017 VAI US FDA
  • 10 April 2015 VAI US FDA
  • 7 July 2011 NAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Benniu Town, China Not on file
China, China 3003662818
Changzhou, China Not on file

What they file, and where

Molecule Regulators Docs
Benzocaine EDQM 1

Also appears on these molecule pages

Alogliptin contract manufacturing Benzocaine contract manufacturing Celecoxib contract manufacturing Cinacalcet contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 2 None
US FDA None 1
EMA None 1

Questions about Changzhou Sunlight Pharmaceutical

Does Changzhou Sunlight Pharmaceutical hold a US DMF or a CEP?
Changzhou Sunlight Pharmaceutical holds 1 valid CEP. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Changzhou Sunlight Pharmaceutical FDA-registered?
One site operated by Changzhou Sunlight Pharmaceutical 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 Changzhou Sunlight Pharmaceutical's last inspection go?
The most recent inspection on record closed on 31 May 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Changzhou Sunlight Pharmaceutical manufacture?
3 registered sites are on record, in China (Benniu Town, China and Changzhou). Every site is listed on this page with the register it came from.
What does Changzhou Sunlight Pharmaceutical make?
1 molecule is on record against Changzhou Sunlight Pharmaceutical, including Benzocaine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Changzhou Sunlight Pharmaceutical's GMP?
Current GMP certificates are on record from US FDA and EMA. 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 31 May 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