Suppliers / Zhejiang Jiangbei Pharmaceutical

Zhejiang Jiangbei Pharmaceutical

China 5 employees Updated 9 July 2026

Zhejiang Jiangbei Pharmaceutical is an API manufacturer based in China. It holds 3 active US drug master files and 5 valid CEPs across a filed portfolio of 4 molecules. Its GMP standing is certified by EMA, MHRA (UK) and US FDA. Its most recent recorded inspection, by US FDA, closed on 7 July 2023 as NAI.

3
active US DMFs
5
valid CEPs
4
registered plants 1 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
3 of 3 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

  • 7 July 2023 NAI US FDA
  • 6 May 2016 VAI US FDA
  • 3 April 2014 VAI US FDA

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

Registered plants

Site FDA FEI
TAIZHOU, China Not on file
TAIZHOU, China Not on file
Taizhou City, China Not on file
China, China 3004986814

What they file, and where

Molecule Regulators Docs
Simvastatin EDQM, US FDA 4
Atorvastatin EDQM, SFDA (Saudi Arabia), US FDA 3
Levetiracetam EDQM 1
Rosuvastatin EDQM 1

Also appears on these molecule pages

Atorvastatin API Calci contract manufacturing Empagliflozin contract manufacturing Rosuvastatin contract manufacturing Simvastatin API Levetiracetam API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 1
MHRA (UK) None 1
US FDA None 1

Questions about Zhejiang Jiangbei Pharmaceutical

Does Zhejiang Jiangbei Pharmaceutical hold a US DMF or a CEP?
Zhejiang Jiangbei Pharmaceutical holds 3 active US drug master files and 5 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 Jiangbei Pharmaceutical FDA-registered?
One site operated by Zhejiang Jiangbei 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 Zhejiang Jiangbei Pharmaceutical's last inspection go?
The most recent inspection on record closed on 7 July 2023 as NAI (No Action Indicated: nothing objectionable was found). 3 inspections are on file.
Where does Zhejiang Jiangbei Pharmaceutical manufacture?
4 registered sites are on record, in China (Taizhou, Taizhou City and China among others). Every site is listed on this page with the register it came from.
What does Zhejiang Jiangbei Pharmaceutical make?
4 molecules are on record against Zhejiang Jiangbei Pharmaceutical, including Simvastatin, Atorvastatin, Levetiracetam and Rosuvastatin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhejiang Jiangbei Pharmaceutical's GMP?
Current GMP certificates are on record from EMA, MHRA (UK) 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.

Comparing suppliers?

Choose your molecules and target markets. Zhejiang Jiangbei Pharmaceutical comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was NAI, on 7 July 2023.

Comparable suppliers

Hetero shares 2 molecules Lupin shares 2 molecules Biocon shares 2 molecules Apitoria Pharma shares 1 molecule Dr Reddy's Laboratories shares 1 molecule

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