Suppliers / Zhejiang Lepu Pharmaceutical

Zhejiang Lepu Pharmaceutical

China Updated 9 July 2026

Zhejiang Lepu Pharmaceutical is an API manufacturer based in China. It holds 11 active US drug master files across a filed portfolio of 11 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 25 April 2025 as VAI.

11
active US DMFs
0
valid CEPs
1
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
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 25 April 2025 VAI US FDA
  • 7 December 2018 VAI US FDA
  • 29 August 2014 NAI US FDA
  • 15 April 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
China, China 3004414647

What they file, and where

Molecule Regulators Docs
Atorvastatin US FDA 2
Rosuvastatin US FDA 2
Azelastine US FDA 1
Clopidogrel US FDA 1
Esomeprazole US FDA 1
Idelalisib US FDA 1
Linezolid US FDA 1
Macitentan SFDA (Saudi Arabia) 1
Pazopanib US FDA 1
Ponatinib US FDA 1
Show all 11 molecules on file
Vortioxetine Hemihydrobromide SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Azelastine API Linezolid API Macitentan API Pazopanib API Atorvastatin API Rosuvastatin API Clopidogrel API Esomeprazole API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Zhejiang Lepu Pharmaceutical

Does Zhejiang Lepu Pharmaceutical hold a US DMF or a CEP?
Zhejiang Lepu Pharmaceutical holds 11 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 Lepu Pharmaceutical FDA-registered?
One site operated by Zhejiang Lepu 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 Lepu Pharmaceutical's last inspection go?
The most recent inspection on record closed on 25 April 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Zhejiang Lepu Pharmaceutical manufacture?
1 registered site is on record, in China (China). Every site is listed on this page with the register it came from.
What does Zhejiang Lepu Pharmaceutical make?
11 molecules are on record against Zhejiang Lepu Pharmaceutical, including Atorvastatin, Rosuvastatin, Azelastine and Clopidogrel. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhejiang Lepu Pharmaceutical's GMP?
Current GMP certificates are on record from 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 25 April 2025.

Comparable suppliers

Zydus Lifesciences shares 3 molecules MSN Laboratories shares 2 molecules Dr Reddy's Laboratories shares 2 molecules Alembic Pharmaceuticals shares 2 molecules Laurus Labs shares 2 molecules

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