Suppliers / Astellas Pharma

Astellas Pharma

Japan 7 duplicate records merged Updated 9 July 2026

Astellas Pharma is an API and finished-dose manufacturer based in Japan. It holds one valid CEP across a filed portfolio of 2 molecules. Its filings concentrate with MHRA (UK), DKMA (DK) and SWISSMEDIC (CH).

0
active US DMFs
1
valid CEPs
2
registered plants
186
filings across 11 regulators

Registered plants

Site FDA FEI
Wallisellen, Switzerland Not on file
Tokyo, Japan Not on file

What they file, and where

Molecule Regulators Docs
Tacrolimus SFDA (Saudi Arabia) 1
Tamsulosin EDQM 1

Also appears on these molecule pages

Micafungin finished dose Mirabegron finished dose Tacrolimus API Tamsulosin API

Filings and GMP by regulator

Regulator Filings GMP certificates
MHRA (UK) 61 None
DKMA (DK) 35 None
SWISSMEDIC (CH) 31 None
ANSM (FR) 14 None
SFDA (Saudi Arabia) 13 None
FAMHP (BE) 11 None

Questions about Astellas Pharma

Does Astellas Pharma hold a US DMF or a CEP?
Astellas Pharma holds 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 Astellas Pharma manufacture?
2 registered sites are on record, in Switzerland and Japan (Wallisellen and Tokyo). Every site is listed on this page with the register it came from.
What does Astellas Pharma make?
2 molecules are on record against Astellas Pharma, including Tacrolimus and Tamsulosin. Each links through to that molecule's full manufacturer list.
Where does Astellas Pharma file?
Filings are on record with MHRA (UK), DKMA (DK), SWISSMEDIC (CH), ANSM (FR) and 7 other regulators, 186 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