Suppliers / Nippon Rika

Nippon Rika

Japan Updated 9 July 2026

Nippon Rika is an API manufacturer based in Japan. It holds 2 active US drug master files and 2 valid CEPs across a filed portfolio of 2 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 4 July 2025 as VAI.

2
active US DMFs
2
valid CEPs
2
registered plants 1 with an FDA FEI number
0
filings across 0 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

  • 4 July 2025 VAI US FDA
  • 9 August 2018 NAI US FDA
  • 13 February 2015 VAI US FDA
  • 22 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 3002807731
Tokyo, Japan Not on file

What they file, and where

Molecule Regulators Docs
Tyrosine EDQM, SFDA (Saudi Arabia), US FDA 3
Acetylcysteine EDQM, US FDA 2

Also appears on these molecule pages

Acetylcysteine API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Nippon Rika

Does Nippon Rika hold a US DMF or a CEP?
Nippon Rika holds 2 active US drug master files and 2 valid CEPs. 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 Nippon Rika FDA-registered?
One site operated by Nippon Rika 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 Nippon Rika's last inspection go?
The most recent inspection on record closed on 4 July 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Nippon Rika manufacture?
2 registered sites are on record, in Japan (Japan and Tokyo). Every site is listed on this page with the register it came from.
What does Nippon Rika make?
2 molecules are on record against Nippon Rika, including Tyrosine and Acetylcysteine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Nippon Rika's GMP?
Current GMP certificates are on record from 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 4 July 2025.

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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