Suppliers / Shanghai New Hualian Pharmaceutical

Shanghai New Hualian Pharmaceutical

China Updated 9 July 2026

Shanghai New Hualian Pharmaceutical is an API manufacturer based in China. It holds one active US drug master file and one valid CEP across a filed portfolio of 2 molecules.

1
active US DMFs
1
valid CEPs
1
registered plants
1
filings across 1 regulators

Registered plants

Site FDA FEI
Shanghai, China Not on file

What they file, and where

Molecule Regulators Docs
Isotretinoin EDQM, SFDA (Saudi Arabia) 2
Hydrocortisone US FDA 1

Also appears on these molecule pages

Hydrocortisone API Isotretinoin API

Filings and GMP by regulator

Regulator Filings GMP certificates
EEC_EAEU 1 None

Questions about Shanghai New Hualian Pharmaceutical

Does Shanghai New Hualian Pharmaceutical hold a US DMF or a CEP?
Shanghai New Hualian Pharmaceutical holds 1 active US drug master file and 1 valid CEP. 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.
Where does Shanghai New Hualian Pharmaceutical manufacture?
1 registered site is on record, in China (Shanghai). Every site is listed on this page with the register it came from.
What does Shanghai New Hualian Pharmaceutical make?
2 molecules are on record against Shanghai New Hualian Pharmaceutical, including Isotretinoin and Hydrocortisone. Each links through to that molecule's full manufacturer list.
Where does Shanghai New Hualian Pharmaceutical file?
Filings are on record with EEC (Eurasian Economic Union), 1 in total.

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