Suppliers / Shandong Xinhua Pharmaceutical

Shandong Xinhua Pharmaceutical

China XIN.F 100 employees 2 duplicate records merged Updated 9 July 2026

Shandong Xinhua Pharmaceutical is an API manufacturer based in China. It holds 42 active US drug master files across a filed portfolio of 17 molecules. Its filings concentrate with US FDA, MINSA (CR) and JFDA (JO). Its GMP standing is certified by MFDS (Korea).

42
active US DMFs
0
valid CEPs
0
registered plants
10
filings across 5 regulators

What they file, and where

Molecule Regulators Docs
Acetylsalicylic Acid SFDA (Saudi Arabia), US FDA 5
Caffeine SFDA (Saudi Arabia), US FDA 4
Glimepiride US FDA 4
Hydrocortisone US FDA 4
Ibuprofen US FDA 4
Prednisone US FDA 4
Carbidopa SFDA (Saudi Arabia), US FDA 3
Levodopa SFDA (Saudi Arabia), US FDA 3
Calcium Polycarbophil US FDA 2
Meloxicam US FDA 2
Show all 17 molecules on file
Metamizole US FDA 2
Phenobarbital US FDA 2
Prednisolone US FDA 2
Sevelamer US FDA 2
Theophylline US FDA 2
Trimethoprim US FDA 2
Antipyrine SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Acetylsalicylic Acid API Caffeine API Carbidopa API Glimepiride API Hydrocortisone API Ibuprofen API Levodopa API Meloxicam API Phenobarbital API Prednisolone API Prednisone API Sevelamer API
Show 2 more molecule pages
Theophylline API Trimethoprim API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 4 None
MINSA (CR) 3 None
JFDA (JO) 1 None
EFDA (ET) 1 None
ARCSA (EC) 1 None
MFDS (Korea) None 2

Questions about Shandong Xinhua Pharmaceutical

Does Shandong Xinhua Pharmaceutical hold a US DMF or a CEP?
Shandong Xinhua Pharmaceutical holds 42 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.
What does Shandong Xinhua Pharmaceutical make?
17 molecules are on record against Shandong Xinhua Pharmaceutical, including Acetylsalicylic Acid, Caffeine, Glimepiride and Hydrocortisone. Each links through to that molecule's full manufacturer list.
Which regulators recognise Shandong Xinhua Pharmaceutical's GMP?
Current GMP certificates are on record from MFDS (Korea). 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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Sources on this page

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