Suppliers / Shanghai Pharma Group Changzhou Kony Pharmaceutical

Shanghai Pharma Group Changzhou Kony Pharmaceutical

China Updated 9 July 2026

Shanghai Pharma Group Changzhou Kony Pharmaceutical is an API manufacturer based in China. It holds 5 active US drug master files and 6 valid CEPs across a filed portfolio of 10 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 10 November 2023 as NAI.

5
active US DMFs
6
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
2 of 2 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 10 November 2023 NAI US FDA
  • 29 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
Luoyang Town, China Not on file
China, China 3004175957

What they file, and where

Molecule Regulators Docs
Ganciclovir EDQM, US FDA 2
Valganciclovir EDQM, US FDA 2
Ciclopirox EDQM 1
Ciclopirox Olamine EDQM 1
Eslicarbazepine Acetate US FDA 1
Famciclovir US FDA 1
Penciclovir SFDA (Saudi Arabia) 1
Perindopril Tert-Butylamine EDQM 1
Tamsulosin EDQM 1
Valaciclovir US FDA 1

Also appears on these molecule pages

Ciclopirox API Ciclopirox Olamine API Eslicarbazepine API Famciclovir API Ganciclovir API Penciclovir API Perindopril Tert-Butylamine API Tamsulosin API Valaciclovir API Valacyclovir API Valganciclovir API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Shanghai Pharma Group Changzhou Kony Pharmaceutical

Does Shanghai Pharma Group Changzhou Kony Pharmaceutical hold a US DMF or a CEP?
Shanghai Pharma Group Changzhou Kony Pharmaceutical holds 5 active US drug master files and 6 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 Shanghai Pharma Group Changzhou Kony Pharmaceutical FDA-registered?
One site operated by Shanghai Pharma Group Changzhou Kony 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 Shanghai Pharma Group Changzhou Kony Pharmaceutical's last inspection go?
The most recent inspection on record closed on 10 November 2023 as NAI (No Action Indicated: nothing objectionable was found). 2 inspections are on file.
Where does Shanghai Pharma Group Changzhou Kony Pharmaceutical manufacture?
2 registered sites are on record, in China (Luoyang Town and China). Every site is listed on this page with the register it came from.
What does Shanghai Pharma Group Changzhou Kony Pharmaceutical make?
10 molecules are on record against Shanghai Pharma Group Changzhou Kony Pharmaceutical, including Ganciclovir, Valganciclovir, Ciclopirox and Ciclopirox Olamine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Shanghai Pharma Group Changzhou Kony 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 10 November 2023.

Comparable suppliers

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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