Suppliers / Chengda Pharmaceuticals

Chengda Pharmaceuticals

China 17 employees Updated 9 July 2026

Chengda Pharmaceuticals is an API manufacturer based in China. It holds 8 active US drug master files and 2 valid CEPs across a filed portfolio of 6 molecules. Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 15 November 2024 as NAI.

8
active US DMFs
2
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
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 15 November 2024 NAI US FDA
  • 25 March 2016 VAI US FDA
  • 15 March 2013 NAI US FDA

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

Registered plants

Site FDA FEI
Jiashan, China Not on file
China, China 3004248447

What they file, and where

Molecule Regulators Docs
Levocarnitine EDQM, SFDA (Saudi Arabia), US FDA 3
Acalabrutinib US FDA 2
Brivaracetam EDQM, US FDA 2
Venetoclax US FDA 2
Elagolix US FDA 1
Rivaroxaban US FDA 1

Also appears on these molecule pages

Acalabrutinib API Brivaracetam API Calci contract manufacturing Dimethyl contract manufacturing Elagolix API Lapatinib contract manufacturing Levocarnitine contract manufacturing Levofloxacin contract manufacturing Linagliptin contract manufacturing Loxoprofen contract manufacturing Nevirapine contract manufacturing Ofloxacin contract manufacturing
Show 6 more molecule pages
Rivaroxaban contract manufacturing Sitagliptin contract manufacturing Sorafenib contract manufacturing Sunitinib contract manufacturing Venetoclax API Vildagliptin contract manufacturing

Filings and GMP by regulator

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

Questions about Chengda Pharmaceuticals

Does Chengda Pharmaceuticals hold a US DMF or a CEP?
Chengda Pharmaceuticals holds 8 active US drug master files and 2 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 Chengda Pharmaceuticals FDA-registered?
One site operated by Chengda 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 Chengda Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 15 November 2024 as NAI (No Action Indicated: nothing objectionable was found). 3 inspections are on file.
Where does Chengda Pharmaceuticals manufacture?
2 registered sites are on record, in China (Jiashan and China). Every site is listed on this page with the register it came from.
What does Chengda Pharmaceuticals make?
6 molecules are on record against Chengda Pharmaceuticals, including Levocarnitine, Acalabrutinib, Brivaracetam and Venetoclax. Each links through to that molecule's full manufacturer list.
Which regulators recognise Chengda Pharmaceuticals'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.

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Open risk flags

  • The most recent inspection outcome was NAI, on 15 November 2024.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates