Suppliers / Zhejiang Changhai Pharmaceuticals

Zhejiang Changhai Pharmaceuticals

China Updated 9 July 2026

Zhejiang Changhai Pharmaceuticals is an API manufacturer based in China. It holds 3 active US drug master files across a filed portfolio of 3 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 26 May 2023 as NAI.

3
active US DMFs
0
valid CEPs
2
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
1 of 1 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

  • 26 May 2023 NAI US FDA

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

Registered plants

Site FDA FEI
Shaoxing, China Not on file
China, China 3013591876

What they file, and where

Molecule Regulators Docs
Linezolid US FDA 1
Minocycline US FDA 1
Rifamycin US FDA 1

Also appears on these molecule pages

Linezolid API Minocycline API Rifamycin API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 2
US FDA None 1

Questions about Zhejiang Changhai Pharmaceuticals

Does Zhejiang Changhai Pharmaceuticals hold a US DMF or a CEP?
Zhejiang Changhai Pharmaceuticals holds 3 active US drug master files. 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 Changhai Pharmaceuticals FDA-registered?
One site operated by Zhejiang Changhai Pharmaceuticals 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 Changhai Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 26 May 2023 as NAI (No Action Indicated: nothing objectionable was found). 1 inspection is on file.
Where does Zhejiang Changhai Pharmaceuticals manufacture?
2 registered sites are on record, in China (Shaoxing and China). Every site is listed on this page with the register it came from.
What does Zhejiang Changhai Pharmaceuticals make?
3 molecules are on record against Zhejiang Changhai Pharmaceuticals, including Linezolid, Minocycline and Rifamycin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhejiang Changhai Pharmaceuticals'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.

Comparing suppliers?

Choose your molecules and target markets. Zhejiang Changhai Pharmaceuticals 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 26 May 2023.

Comparable suppliers

Dr Reddy's Laboratories shares 1 molecule Alivus Life Sciences shares 1 molecule Alembic Pharmaceuticals shares 1 molecule Olon shares 1 molecule Zydus Lifesciences 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