Suppliers / Alps Pharmaceutical Ind

Alps Pharmaceutical Ind

Japan Updated 9 July 2026

Alps Pharmaceutical Ind is an API manufacturer based in Japan. It holds one active US drug master file and 3 valid CEPs across a filed portfolio of 4 molecules.

1
active US DMFs
3
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
Sources: FDA Establishment Registration, read 4 May 2026.

Registered plants

Site FDA FEI
Hida, Japan Not on file
Japan, Japan 0000001073

What they file, and where

Molecule Regulators Docs
Enoxolone EDQM 1
Protamine Sulfate US FDA 1
Rutin EDQM 1
Rutoside Trihydrate EDQM 1

Also appears on these molecule pages

Protamine API

Questions about Alps Pharmaceutical Ind

Does Alps Pharmaceutical Ind hold a US DMF or a CEP?
Alps Pharmaceutical Ind holds 1 active US drug master file and 3 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 Alps Pharmaceutical Ind FDA-registered?
One site operated by Alps Pharmaceutical Ind 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.
Where does Alps Pharmaceutical Ind manufacture?
2 registered sites are on record, in Japan (Hida and Japan). Every site is listed on this page with the register it came from.
What does Alps Pharmaceutical Ind make?
4 molecules are on record against Alps Pharmaceutical Ind, including Enoxolone, Protamine Sulfate, Rutin and Rutoside Trihydrate. Each links through to that molecule's full manufacturer list.

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