Suppliers / Ohara Pharmaceutical

Ohara Pharmaceutical

Japan Updated 9 July 2026

Ohara Pharmaceutical is a finished-dose manufacturer based in Japan. It appears in 1 regulatory filing across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by MFDS (Korea).

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

Filings and GMP by regulator

Regulator Filings GMP certificates
NPRA (MY) 1 None
MFDS (Korea) None 2

Limited public record

Beyond the filing counts above, the public registers hold no plant, inspection or portfolio detail for this company as at 9 July 2026. We report that as a gap rather than inferring an answer.

Questions about Ohara Pharmaceutical

Does Ohara Pharmaceutical hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Ohara Pharmaceutical. It does have 1 filing with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Which regulators recognise Ohara Pharmaceutical'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