Suppliers / Zhejiang Raybow

Zhejiang Raybow

China reconciled across 5 public records · 2 entities Updated 9 July 2026

Zhejiang Raybow is an API manufacturer based in China. It holds 5 active US drug master files and 2 valid CEPs across a filed portfolio of 6 molecules. Its GMP standing is certified by US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 22 May 2025 as NAI.

5
active US DMFs
2
valid CEPs
4
registered plants 2 with an FDA FEI number
0
filings across 0 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

  • 22 May 2025 NAI US FDA
  • 1 November 2024 NAI US FDA
  • 11 July 2019 VAI US FDA
  • 18 October 2018 NAI US FDA
  • 22 April 2016 NAI US FDA
  • 19 September 2014 NAI US FDA
  • 29 April 2014 VAI US FDA
  • 25 May 2010 NAI US FDA

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

Registered plants

Site FDA FEI
China, China 3007114474
Taizhou City, China Not on file
Taizhou, China Not on file
China, China 3005842033

What they file, and where

Molecule Regulators Docs
Venlafaxine US FDA 2
Carbamazepine EDQM 1
Eribulin US FDA 1
Ketoprofen SFDA (Saudi Arabia) 1
Sacubitril US FDA 1
Venlafaxine Hydrochloride EDQM 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 2
EMA None 1

Questions about Zhejiang Raybow

Does Zhejiang Raybow hold a US DMF or a CEP?
Zhejiang Raybow holds 5 active US drug master files and 2 valid CEPs. 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 Zhejiang Raybow FDA-registered?
2 sites operated by Zhejiang Raybow carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Zhejiang Raybow's last inspection go?
The most recent inspection on record closed on 22 May 2025 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Zhejiang Raybow manufacture?
4 registered sites are on record, in China (China, Taizhou City and Taizhou among others). Every site is listed on this page with the register it came from.
What does Zhejiang Raybow make?
6 molecules are on record against Zhejiang Raybow, including Venlafaxine, Carbamazepine, Eribulin and Ketoprofen. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhejiang Raybow'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 NAI, on 22 May 2025.

Sources on this page

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