Is Bidachem S.p.a. FDA approved?

Bidachem S.p.a. holds 1 FDA-registered establishment 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 Bidachem S.p.a.'s drugs manufactured?

The FDA register lists Fornovo S. Giovanni (BG). Registered operations: analytical testing, active ingredient (API) manufacture.

What drugs does Bidachem S.p.a. make?

8 products are listed under Bidachem S.p.a. 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.

Bidachem S.p.a.

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

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Registered sites: 1
Active NDC listings: 8
Live patents: 0
Countries: 1
Base: Italy

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Bidachem S.p.a.	Strada Statale 11 (Padana Superiore), 8, Fornovo S. Giovanni (BG), Italy 24040, Italy (ITA)	Analytical testing, Active ingredient (API) manufacture	3002806598429232812

Catalogue

Drug listings by form and route

8 active NDC listings: 8 bulk ingredient. By marketing category: BULK INGREDIENT 7, EXPORT ONLY 1.

Dosage form	NDCs
powder	8

Route	NDCs

Labeller name on the listing	NDCs
bidachem s.p.a.	8

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Bromhexine Hydrochloride	powder	51869-0009EXPORT ONLY
-	Dabigatran	powder	51869-0030BULK INGREDIENT
-	Empagliflozin	powder	51869-0015BULK INGREDIENT
-	Linagliptin	powder	51869-0020BULK INGREDIENT
-	Nintedanib	powder	51869-0040BULK INGREDIENT
-	flibanserin	powder	51869-0050BULK INGREDIENT
-	meloxicam	powder	51869-0007BULK INGREDIENT
-	meloxicam	powder	51869-0008BULK INGREDIENT

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Societa Italiana Medicinali Scandicci S.I.M.S. SrL1 site · 12 NDC

Enquiry

Common questions

Is Bidachem S.p.a. FDA approved?: Bidachem S.p.a. holds 1 FDA-registered establishment 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 Bidachem S.p.a.'s drugs manufactured?: The FDA register lists Fornovo S. Giovanni (BG). Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does Bidachem S.p.a. make?: 8 products are listed under Bidachem S.p.a. 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.