Suppliers / Rohto Pharmaceutical

Rohto Pharmaceutical

Japan 254 employees Updated 9 July 2026

Rohto Pharmaceutical is a finished-dose manufacturer based in Japan. It appears in 4 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with DAV (Vietnam) and EFDA (ET). Its most recent recorded inspection, by US FDA, closed on 8 March 2023 as VAI.

0
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
4
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 8 March 2023 VAI US FDA
  • 2 March 2018 VAI US FDA
  • 14 November 2014 VAI US FDA
  • 20 November 2012 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Mie, United Arab Emirates Not on file
Japan, Japan 3003722237

Filings and GMP by regulator

Regulator Filings GMP certificates
DAV (Vietnam) 2 None
EFDA (ET) 2 None

Questions about Rohto Pharmaceutical

Does Rohto Pharmaceutical hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Rohto Pharmaceutical. It does have 4 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Rohto Pharmaceutical FDA-registered?
One site operated by Rohto Pharmaceutical 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.
How did Rohto Pharmaceutical's last inspection go?
The most recent inspection on record closed on 8 March 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Rohto Pharmaceutical manufacture?
2 registered sites are on record, in United Arab Emirates and Japan (Mie and Japan). Every site is listed on this page with the register it came from.
Where does Rohto Pharmaceutical file?
Filings are on record with DAV (Vietnam) and EFDA (ET), 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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Open risk flags

  • The most recent inspection outcome was VAI, on 8 March 2023.

Comparable suppliers

Bushu Pharmaceuticals also in Japan Chugai Pharma Manufacturing also in Japan Eisai also in Japan Hisamitsu Pharmaceutical also in Japan Kyowa Kirin also in Japan

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability