Suppliers / AMSA

AMSA

Italy Updated 9 July 2026

AMSA is an API manufacturer based in Italy. It holds 6 active US drug master files and 5 valid CEPs across a filed portfolio of 10 molecules. Its filings concentrate with BRELA (TZ) and MINSA (CR).

6
active US DMFs
5
valid CEPs
1
registered plants
2
filings across 2 regulators

Registered plants

Site FDA FEI
- ANONIMA MATERIE SINTETICHE & AFFINI Como, Italy Not on file

What they file, and where

Molecule Regulators Docs
Glycopyrronium EDQM, SFDA (Saudi Arabia), US FDA 3
Diclofenac US FDA 1
Etodolac US FDA 1
Flecainide EDQM 1
Glipizide US FDA 1
Levodropropizine EDQM 1
Lurasidone US FDA 1
Meloxicam EDQM 1
Metoclopramide EDQM 1
Viloxazine US FDA 1

Also appears on these molecule pages

Diclofenac API Etodolac API Flecainide API Glipizide API Glycopyrronium API Levodropropizine API Meloxicam API Metoclopramide API Viloxazine API Lurasidone API

Filings and GMP by regulator

Regulator Filings GMP certificates
BRELA (TZ) 1 None
MINSA (CR) 1 None

Questions about AMSA

Does AMSA hold a US DMF or a CEP?
AMSA holds 6 active US drug master files and 5 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.
Where does AMSA manufacture?
1 registered site is on record, in Italy (- Anonima Materie Sintetiche & Affini Como). Every site is listed on this page with the register it came from.
What does AMSA make?
10 molecules are on record against AMSA, including Glycopyrronium, Diclofenac, Etodolac and Flecainide. Each links through to that molecule's full manufacturer list.
Where does AMSA file?
Filings are on record with BRELA (TZ) and MINSA (CR), 2 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