Suppliers / Shandong Chenghui Shuangda Pharmaceutical

Shandong Chenghui Shuangda Pharmaceutical

China 11 employees Updated 9 July 2026

Shandong Chenghui Shuangda Pharmaceutical is an API manufacturer based in China. It holds 4 active US drug master files across a filed portfolio of 4 molecules. Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 14 March 2025 as VAI.

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

Inspection history

  • 14 March 2025 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 3021190106

What they file, and where

Molecule Regulators Docs
Pramocaine US FDA 1
Prilocaine US FDA 1
Tetracaine US FDA 1
Vonoprazan US FDA 1

Also appears on these molecule pages

Pramocaine API Prilocaine API Tetracaine API Vonoprazan API

Filings and GMP by regulator

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

Questions about Shandong Chenghui Shuangda Pharmaceutical

Does Shandong Chenghui Shuangda Pharmaceutical hold a US DMF or a CEP?
Shandong Chenghui Shuangda Pharmaceutical holds 4 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 Shandong Chenghui Shuangda Pharmaceutical FDA-registered?
One site operated by Shandong Chenghui Shuangda 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 Shandong Chenghui Shuangda Pharmaceutical's last inspection go?
The most recent inspection on record closed on 14 March 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Shandong Chenghui Shuangda 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 Shandong Chenghui Shuangda Pharmaceutical make?
4 molecules are on record against Shandong Chenghui Shuangda Pharmaceutical, including Pramocaine, Prilocaine, Tetracaine and Vonoprazan. Each links through to that molecule's full manufacturer list.
Which regulators recognise Shandong Chenghui Shuangda 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.

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Open risk flags

  • The most recent inspection outcome was VAI, on 14 March 2025.

Comparable suppliers

W. R. Grace & Co.-Conn shares 2 molecules Apitoria Pharma shares 1 molecule Dr Reddy's Laboratories shares 1 molecule Neuland Laboratories shares 1 molecule Maithri Drugs 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