Suppliers / Amsa – Anonima Materie Sintetiche & Affini

Amsa – Anonima Materie Sintetiche & Affini

Italy Updated 9 July 2026

Amsa – Anonima Materie Sintetiche & Affini is an API manufacturer based in Italy. It holds 6 active US drug master files across a filed portfolio of 2 molecules.

6
active US DMFs
0
valid CEPs
1
registered plants
1
filings across 1 regulators

Registered plants

Site FDA FEI
COMO, Italy Not on file

What they file, and where

Molecule Regulators Docs
Amantadine US FDA 3
Meloxicam US FDA 3

Also appears on these molecule pages

Amantadine API Meloxicam API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 1 None

Questions about Amsa – Anonima Materie Sintetiche & Affini

Does Amsa – Anonima Materie Sintetiche & Affini hold a US DMF or a CEP?
Amsa – Anonima Materie Sintetiche & Affini holds 6 active US drug master files. 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.
Where does Amsa – Anonima Materie Sintetiche & Affini manufacture?
1 registered site is on record, in Italy (Como). Every site is listed on this page with the register it came from.
What does Amsa – Anonima Materie Sintetiche & Affini make?
2 molecules are on record against Amsa – Anonima Materie Sintetiche & Affini, including Amantadine and Meloxicam. Each links through to that molecule's full manufacturer list.
Where does Amsa – Anonima Materie Sintetiche & Affini file?
Filings are on record with MINSA (CR), 1 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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Sources on this page

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