Suppliers / Daito

Daito

Japan Updated 9 July 2026

Daito is an API manufacturer based in Japan. It holds one active US drug master file. Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 19 December 2023 as VAI.

1
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 19 December 2023 VAI US FDA
  • 16 September 2022 VAI US FDA
  • 29 September 2011 VAI US FDA

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

Registered plants

Site FDA FEI
Japan, Japan 3002806779

What they file, and where

Molecule Regulators Docs
Azelastine US FDA 1

Also appears on these molecule pages

Azelastine API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 1 1
MFDS (Korea) None 2

Questions about Daito

Does Daito hold a US DMF or a CEP?
Daito 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.
Is Daito FDA-registered?
One site operated by Daito 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 Daito's last inspection go?
The most recent inspection on record closed on 19 December 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Daito manufacture?
1 registered site is on record, in Japan (Japan). Every site is listed on this page with the register it came from.
What does Daito make?
1 molecule is on record against Daito, including Azelastine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Daito's GMP?
Current GMP certificates are on record from MFDS (Korea) and US FDA. 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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Open risk flags

  • The most recent inspection outcome was VAI, on 19 December 2023.

Comparable suppliers

MSN Laboratories shares 1 molecule Zydus Lifesciences shares 1 molecule “Gedeon Richter” shares 1 molecule Coral Drugs shares 1 molecule Zhejiang Lepu Pharmaceutical shares 1 molecule

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
EudraGMDP and national regulators
GMP certificates