Suppliers / Kyorin Pharmaceutical

Kyorin Pharmaceutical

Japan 49 employees 2 duplicate records merged Updated 9 July 2026

Kyorin Pharmaceutical is an API and finished-dose manufacturer based in Japan. It holds one active US drug master file across a filed portfolio of 2 molecules. Its filings concentrate with NPRA (MY), ARCSA (EC) and DIGEMAPS (DO).

1
active US DMFs
0
valid CEPs
0
registered plants
4
filings across 3 regulators

What they file, and where

Molecule Regulators Docs
Gatifloxacin US FDA 1
Imidafenacin SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Gatifloxacin API Vibegron finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
NPRA (MY) 2 None
ARCSA (EC) 1 None
DIGEMAPS (DO) 1 None

Questions about Kyorin Pharmaceutical

Does Kyorin Pharmaceutical hold a US DMF or a CEP?
Kyorin Pharmaceutical 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.
What does Kyorin Pharmaceutical make?
2 molecules are on record against Kyorin Pharmaceutical, including Gatifloxacin and Imidafenacin. Each links through to that molecule's full manufacturer list.
Where does Kyorin Pharmaceutical file?
Filings are on record with NPRA (MY), ARCSA (EC) and DIGEMAPS (DO), 4 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