Is CHEMI SpA FDA approved?

CHEMI SpA holds 2 FDA-registered establishments in Italy. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are CHEMI SpA's drugs manufactured?

The FDA register lists Cinisello Balsamo; PATRICA. Registered operations: analytical testing, active ingredient (API) manufacture.

What drugs does CHEMI SpA make?

4 products are listed under CHEMI SpA in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

CHEMI SpA

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 2
Active NDC listings: 4
Live patents: 0
Countries: 1
Base: Italy

Authorisation

Registered operations

Analytical testing2Active ingredient (API) manufacture2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
CHEMI SpA	Via Dei Lavoratori 54, Cinisello Balsamo, Milano 20092, Italy (ITA)	Analytical testing, Active ingredient (API) manufacture	3000326763432435238
CHEMI SpA	VIA VADISI 5, PATRICA, FROSINONE 03010, Italy (ITA)	Analytical testing, Active ingredient (API) manufacture	3002806667542987644

Catalogue

Drug listings by form and route

4 active NDC listings: 4 bulk ingredient. By marketing category: BULK INGREDIENT 4.

Dosage form	NDCs
powder	4

Route	NDCs

Labeller name on the listing	NDCs
chemi spa	4

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	MESALAMINE	powder	54127-0943BULK INGREDIENT
-	MESALAMINE	powder	54127-0945BULK INGREDIENT
-	MESALAMINE	powder	54127-0947BULK INGREDIENT
-	MESALAMINE	powder	54127-0950BULK INGREDIENT

Compare

Comparable companies in Italy

Erregierre SpA2 sites · 36 NDC
Newchem S.p.A.2 sites · 33 NDC
Novo Nordisk Production Belgium SA2 sites · 24 NDC
Indena SpA2 sites · 15 NDC
Italfarmaco S.A.2 sites · 15 NDC
Lusochimica SPA2 sites · 13 NDC
Doppel Farmaceutici S.r.l.2 sites · 10 NDC
Trifarma S.p.A.2 sites · 10 NDC
OPOCRIN SPA2 sites · 2 NDC
AMSA Anonima Materie Sintetiche ED Affini Spa2 sites · 0 NDC

Enquiry

Common questions

Is CHEMI SpA FDA approved?: CHEMI SpA holds 2 FDA-registered establishments in Italy. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are CHEMI SpA's drugs manufactured?: The FDA register lists Cinisello Balsamo; PATRICA. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does CHEMI SpA make?: 4 products are listed under CHEMI SpA in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.