Is Aesica Pharmaceuticals S.r.l. FDA approved?

Aesica Pharmaceuticals S.r.l. holds 3 FDA-registered establishments across 2 countries. 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 Aesica Pharmaceuticals S.r.l.'s drugs manufactured?

At registered sites in Germany, Italy. The FDA register lists Monheim am Rhein; Zwickau; Pianezza. Registered operations: analytical testing, finished drug manufacture, packaging, repackaging.

What drugs does Aesica Pharmaceuticals S.r.l. make?

2 products are listed under Aesica Pharmaceuticals S.r.l. in the openFDA NDC Directory, most often as tablet, extended release. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Aesica Pharmaceuticals S.r.l.

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

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Registered sites: 3
Active NDC listings: 2
Live patents: 0
Countries: 2
Base: Germany

Authorisation

Registered operations

Analytical testing3Finished drug manufacture3Packaging2Repackaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Aesica Pharmaceuticals GmbH	Alfred-Nobel-Str. 10, Monheim am Rhein, 40789, Germany (DEU)	Analytical testing, Finished drug manufacture, Packaging, Repackaging	3002943189341737465
Aesica Pharmaceuticals GmbH	Galileistr. 6, Zwickau, 08056, Germany (DEU)	Analytical testing, Finished drug manufacture	3002948883341970412
Aesica Pharmaceuticals S.r.l.	Via Praglia 15, Pianezza, Italy 10044, Italy (ITA)	Analytical testing, Finished drug manufacture, Packaging	3013548751430803851

Catalogue

Drug listings by form and route

2 active NDC listings: 2 drug for further processing. By marketing category: DRUG FOR FURTHER PROCESSING 2.

Dosage form	NDCs
tablet, extended release	2

Route	NDCs

Labeller name on the listing	NDCs
aesica pharmaceuticals gmbh	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Fesoterodine fumarate	tablet, extended release	16262-001DRUG FOR FURTHER PROCESSING
-	Fesoterodine fumarate	tablet, extended release	16262-002DRUG FOR FURTHER PROCESSING

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Enquiry

Common questions

Is Aesica Pharmaceuticals S.r.l. FDA approved?: Aesica Pharmaceuticals S.r.l. holds 3 FDA-registered establishments across 2 countries. 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 Aesica Pharmaceuticals S.r.l.'s drugs manufactured?: At registered sites in Germany, Italy. The FDA register lists Monheim am Rhein; Zwickau; Pianezza. Registered operations: analytical testing, finished drug manufacture, packaging, repackaging.
What drugs does Aesica Pharmaceuticals S.r.l. make?: 2 products are listed under Aesica Pharmaceuticals S.r.l. in the openFDA NDC Directory, most often as tablet, extended release. 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.