Suppliers / Shionogi

Shionogi

Japan 447 employees 5 duplicate records merged Updated 9 July 2026

Shionogi is an API and finished-dose manufacturer based in Japan. It holds one active US drug master file. Its filings concentrate with US FDA, AIFA (IT) and EMA.

1
active US DMFs
0
valid CEPs
1
registered plants
73
filings across 12 regulators

Registered plants

Site FDA FEI
KANEGASAKI-CHO Not on file

What they file, and where

Molecule Regulators Docs
Ospemifene US FDA 1

Also appears on these molecule pages

Edaravone finished dose Ospemifene API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 17 None
AIFA (IT) 13 None
EMA 13 None
FAMHP (BE) 11 None
INFARMED (PT) 6 None
MPA (SE) 4 None

Questions about Shionogi

Does Shionogi hold a US DMF or a CEP?
Shionogi holds 1 active US drug master file. 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 Shionogi manufacture?
1 registered site is on record (Kanegasaki-cho). Every site is listed on this page with the register it came from.
What does Shionogi make?
1 molecule is on record against Shionogi, including Ospemifene. Each links through to that molecule's full manufacturer list.
Where does Shionogi file?
Filings are on record with US FDA, AIFA (IT), EMA, FAMHP (BE) and 8 other regulators, 73 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