Suppliers / Fabbrica Italiana Sintetici

Fabbrica Italiana Sintetici

Italy Updated 9 July 2026

The public registers hold a second record for Fabbrica Italiana Sintetici. The fuller profile, with 43 active US DMFs and 0 valid CEPs, is at F.I.S. Fabbrica Italiana Sintetici. Figures on this page cover only this record.

Fabbrica Italiana Sintetici is an API manufacturer based in Italy. It appears in 2 regulatory filings across 1 regulator, without an active US DMF or CEP on file.

0
active US DMFs
0
valid CEPs
0
registered plants
2
filings across 1 regulators

What they file, and where

Molecule Regulators Docs
Acetylcysteine SFDA (Saudi Arabia) 1
Ataluren SFDA (Saudi Arabia) 1
Dexlansoprazole SFDA (Saudi Arabia) 1
Dorzolamide SFDA (Saudi Arabia) 1
Nitrofurantoin Macrocrystals SFDA (Saudi Arabia) 1
Ranolazine SFDA (Saudi Arabia) 1
Velpatasvir SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Acetylcysteine API Dexlansoprazole API Dorzolamide API Ranolazine API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 2 None

Questions about Fabbrica Italiana Sintetici

Does Fabbrica Italiana Sintetici hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Fabbrica Italiana Sintetici. It does have 2 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
What does Fabbrica Italiana Sintetici make?
7 molecules are on record against Fabbrica Italiana Sintetici, including Acetylcysteine, Ataluren, Dexlansoprazole and Dorzolamide. Each links through to that molecule's full manufacturer list.
Where does Fabbrica Italiana Sintetici file?
Filings are on record with 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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Comparable suppliers

Dr Reddy's Laboratories shares 2 molecules Jubilant Biosys shares 2 molecules Raks Pharma shares 2 molecules MSN Laboratories shares 1 molecule Apitoria Pharma shares 1 molecule

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