Suppliers / Jiangxi Synergy Pharmaceutical

Jiangxi Synergy Pharmaceutical

China 300636.SZ Updated 9 July 2026

Jiangxi Synergy Pharmaceutical is an API manufacturer based in China. It holds 20 active US drug master files across a filed portfolio of 20 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 7 August 2025 as NAI.

20
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
4
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 7 August 2025 NAI US FDA
  • 10 January 2019 VAI US FDA
  • 9 September 2016 VAI US FDA
  • 9 May 2014 VAI US FDA
  • 11 September 2009 VAI 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 3008465739

What they file, and where

Molecule Regulators Docs
Gabapentin SFDA (Saudi Arabia), US FDA 4
Celecoxib SFDA (Saudi Arabia), US FDA 3
Azilsartan Medoxomil US FDA 2
Edoxaban SFDA (Saudi Arabia), US FDA 2
Empagliflozin SFDA (Saudi Arabia), US FDA 2
Vildagliptin SFDA (Saudi Arabia), US FDA 2
Vonoprazan SFDA (Saudi Arabia), US FDA 2
Apixaban US FDA 1
Canagliflozin US FDA 1
Crisaborole US FDA 1
Show all 20 molecules on file
Dabigatran Etexilate US FDA 1
Dapagliflozin US FDA 1
Febuxostat US FDA 1
Mirabegron US FDA 1
Mirabegron Α SFDA (Saudi Arabia) 1
Opicapone US FDA 1
Rabeprazole SFDA (Saudi Arabia) 1
Rivaroxaban US FDA 1
Roxadustat US FDA 1
Ticagrelor US FDA 1

Also appears on these molecule pages

Azilsartan Medoxomil API Canagliflozin API Celecoxib API Crisaborole API Dabigatran Etexilate API Edoxaban API Empagliflozin API Febuxostat API Gabapentin API Rabeprazole API Vildagliptin API Vonoprazan API
Show 5 more molecule pages
Dapagliflozin API Rivaroxaban API Mirabegron API Ticagrelor API Apixaban API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 4 None
US FDA None 1

Questions about Jiangxi Synergy Pharmaceutical

Does Jiangxi Synergy Pharmaceutical hold a US DMF or a CEP?
Jiangxi Synergy Pharmaceutical holds 20 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 Jiangxi Synergy Pharmaceutical FDA-registered?
One site operated by Jiangxi Synergy 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 Jiangxi Synergy Pharmaceutical's last inspection go?
The most recent inspection on record closed on 7 August 2025 as NAI (No Action Indicated: nothing objectionable was found). 5 inspections are on file.
Where does Jiangxi Synergy 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 Jiangxi Synergy Pharmaceutical make?
20 molecules are on record against Jiangxi Synergy Pharmaceutical, including Gabapentin, Celecoxib, Azilsartan Medoxomil and Edoxaban. Each links through to that molecule's full manufacturer list.
Which regulators recognise Jiangxi Synergy 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 NAI, on 7 August 2025.

Comparable suppliers

Apitoria Pharma shares 8 molecules Dr Reddy's Laboratories shares 8 molecules Alembic Pharmaceuticals shares 7 molecules Macleods Pharmaceuticals shares 6 molecules Lupin shares 6 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