Suppliers / Zhejiang Langhua Pharmaceutical

Zhejiang Langhua Pharmaceutical

China Updated 9 July 2026

Zhejiang Langhua Pharmaceutical is an API manufacturer based in China. It holds 3 active US drug master files and 3 valid CEPs across a filed portfolio of 5 molecules. Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 30 August 2024 as VAI.

3
active US DMFs
3
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
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 30 August 2024 VAI US FDA
  • 23 March 2018 NAI US FDA
  • 21 November 2014 VAI US FDA
  • 1 March 2012 VAI US FDA

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

Registered plants

Site FDA FEI
Linhai, China Not on file
China, China 3005289386

What they file, and where

Molecule Regulators Docs
Levofloxacin EDQM, US FDA 2
Spironolactone EDQM, US FDA 2
Empagliflozin US FDA 1
Enrofloxacin For Veterinary Use EDQM 1
Ibrutinib SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Apalutamide contract manufacturing Apremilast contract manufacturing Ciprofloxacin contract manufacturing Dexmedetomidine contract manufacturing Dolutegravir contract manufacturing Eltrombopag contract manufacturing Eluxadoline contract manufacturing Empagliflozin contract manufacturing Ibrutinib API Levofloxacin contract manufacturing Ofloxacin contract manufacturing Olanzapine contract manufacturing
Show 4 more molecule pages
Omeprazole contract manufacturing Sevoflurane contract manufacturing Spironolactone contract manufacturing Tedizolid contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
MFDS (Korea) None 2
US FDA None 1

Questions about Zhejiang Langhua Pharmaceutical

Does Zhejiang Langhua Pharmaceutical hold a US DMF or a CEP?
Zhejiang Langhua Pharmaceutical holds 3 active US drug master files and 3 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 Langhua Pharmaceutical FDA-registered?
One site operated by Zhejiang Langhua 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 Langhua Pharmaceutical's last inspection go?
The most recent inspection on record closed on 30 August 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Zhejiang Langhua Pharmaceutical manufacture?
2 registered sites are on record, in China (Linhai and China). Every site is listed on this page with the register it came from.
What does Zhejiang Langhua Pharmaceutical make?
5 molecules are on record against Zhejiang Langhua Pharmaceutical, including Levofloxacin, Spironolactone, Empagliflozin and Enrofloxacin For Veterinary Use. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhejiang Langhua Pharmaceutical's GMP?
Current GMP certificates are on record from MFDS (Korea) 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.

Checking Zhejiang Langhua Pharmaceutical?

Ask Fred what the record holds on Zhejiang Langhua Pharmaceutical, including filings and inspection history.

Chat with Fred, your AI analyst
Opens WhatsApp. Free to start.

Open risk flags

  • The most recent inspection outcome was VAI, on 30 August 2024.

Comparable suppliers

Hetero shares 2 molecules Dr Reddy's Laboratories shares 2 molecules MSN Laboratories shares 1 molecule Apitoria Pharma shares 1 molecule Cipla 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