Suppliers / Lianyungang Kangle Pharmaceutical

Lianyungang Kangle Pharmaceutical

China Updated 9 July 2026

Lianyungang Kangle Pharmaceutical is an API manufacturer based in China. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 19 September 2025 as VAI.

0
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
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

  • 19 September 2025 VAI US FDA
  • 31 May 2019 VAI US FDA
  • 15 July 2016 VAI US FDA

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

Registered plants

Site FDA FEI
Lianyungang, Jiangsu Province, China Not on file
China, China 3010728729

What they file, and where

Molecule Regulators Docs
Acetaminophen SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Acetaminophen API Paracetamol API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 1
US FDA None 1

Questions about Lianyungang Kangle Pharmaceutical

Is Lianyungang Kangle Pharmaceutical FDA-registered?
One site operated by Lianyungang Kangle 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 Lianyungang Kangle Pharmaceutical's last inspection go?
The most recent inspection on record closed on 19 September 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Lianyungang Kangle Pharmaceutical manufacture?
2 registered sites are on record, in China (Lianyungang, Jiangsu Province and China). Every site is listed on this page with the register it came from.
What does Lianyungang Kangle Pharmaceutical make?
1 molecule is on record against Lianyungang Kangle Pharmaceutical, including Acetaminophen. Each links through to that molecule's full manufacturer list.
Which regulators recognise Lianyungang Kangle Pharmaceutical'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. Lianyungang Kangle 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 VAI, on 19 September 2025.

Comparable suppliers

Apitoria Pharma shares 2 molecules Granules India shares 2 molecules Specgx shares 2 molecules IOL Chemicals and Pharmaceuticals shares 2 molecules Anqiu Lu'an Pharmaceutical 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