Suppliers / Shandong Topscience Biotech

Shandong Topscience Biotech

China Updated 9 July 2026

Shandong Topscience Biotech is an API manufacturer based in China. It holds 2 active US drug master files and 4 valid CEPs across a filed portfolio of 2 molecules. Its GMP standing is certified by MFDS (Korea).

2
active US DMFs
4
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
Sources: FDA Establishment Registration, read 4 May 2026.

Registered plants

Site FDA FEI
Rizhao, China Not on file
China, China 3007647589

What they file, and where

Molecule Regulators Docs
Sodium Hyaluronate EDQM 4
Hyaluronic Acid US FDA 2

Also appears on these molecule pages

Hyaluronic Acid API

Filings and GMP by regulator

Regulator Filings GMP certificates
MFDS (Korea) None 2

Questions about Shandong Topscience Biotech

Does Shandong Topscience Biotech hold a US DMF or a CEP?
Shandong Topscience Biotech holds 2 active US drug master files and 4 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 Shandong Topscience Biotech FDA-registered?
One site operated by Shandong Topscience Biotech 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.
Where does Shandong Topscience Biotech manufacture?
2 registered sites are on record, in China (Rizhao and China). Every site is listed on this page with the register it came from.
What does Shandong Topscience Biotech make?
2 molecules are on record against Shandong Topscience Biotech, including Sodium Hyaluronate and Hyaluronic Acid. Each links through to that molecule's full manufacturer list.
Which regulators recognise Shandong Topscience Biotech'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