Suppliers / Lead Chemical

Lead Chemical

Japan Updated 9 July 2026

Lead Chemical is a finished-dose manufacturer based in Japan. It appears in 4 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with NMPA (CN), EMA and NPRA (MY). Its GMP standing is certified by US FDA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 24 July 2025 as VAI.

0
active US DMFs
0
valid CEPs
4
registered plants 2 with an FDA FEI number
4
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
7 of 7 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 24 July 2025 VAI US FDA
  • 8 December 2023 NAI US FDA
  • 3 August 2018 NAI US FDA
  • 13 July 2017 VAI US FDA
  • 28 August 2015 VAI US FDA
  • 20 September 2013 NAI US FDA
  • 7 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
TOYAMA, Japan Not on file
TOYAMA, Japan Not on file
Japan, Japan 3010165921
Japan, Japan 1000533113

Filings and GMP by regulator

Regulator Filings GMP certificates
NMPA (CN) 2 None
EMA 1 None
NPRA (MY) 1 None
US FDA None 2
ANVISA (Brazil) None 2

Questions about Lead Chemical

Does Lead Chemical hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Lead Chemical. It does have 4 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Is Lead Chemical FDA-registered?
2 sites operated by Lead Chemical carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Lead Chemical's last inspection go?
The most recent inspection on record closed on 24 July 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 7 inspections are on file.
Where does Lead Chemical manufacture?
4 registered sites are on record, in Japan (Toyama and Japan among others). Every site is listed on this page with the register it came from.
Which regulators recognise Lead Chemical's GMP?
Current GMP certificates are on record from US FDA and ANVISA (Brazil). 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 24 July 2025.

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
EudraGMDP and national regulators
GMP certificates