Is Rentschler Biopharma SE FDA approved?

Rentschler Biopharma SE holds 2 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 Rentschler Biopharma SE's drugs manufactured?

At registered sites in Germany, the United States. The FDA register lists Laupheim; Milford, MA. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.

What drugs does Rentschler Biopharma SE make?

8 products are listed under Rentschler Biopharma SE in the openFDA NDC Directory, most often as injection; injection, solution; injection, powder, lyophilized, for solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Rentschler Biopharma SE

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

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Registered sites: 2
Active NDC listings: 8
Live patents: 0
Countries: 2
Base: Germany

Authorisation

Registered operations

Analytical testing2Active ingredient (API) manufacture2Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Rentschler Biopharma SE	Erwin-Rentschler Str. 21, Laupheim, Baden-Wuerttemberg D-88471, Germany (DEU)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	1000291122313166479
Rentschler Biopharma Inc.Registrant: Rentschler Biopharma SE	27 Maple Street, Milford, Massachusetts (MA) 01757, United States (USA)	Analytical testing, Active ingredient (API) manufacture	3003282293116958184

Catalogue

Drug listings by form and route

8 active NDC listings: 8 bulk ingredient. By marketing category: BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 5, BULK INGREDIENT 3.

Dosage form	NDCs
injection	3
injection, solution	3
injection, powder, lyophilized, for solution	2

Route	NDCs

Labeller name on the listing	NDCs
rentschler biopharma se	8

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Antihemophilic Factor (recombinant), Porcine Sequence	injection, solution	64538-500BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	Bimzelx	injection, solution	64538-780BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	Lanadelumab-flyo	injection, solution	64538-644BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	Mepsevii	injection	64538-001BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	Pivekimab Sunirine-pvzy	injection, powder, lyophilized, for solution	64538-282BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	Velmanase Alfa-tycv	injection, powder, lyophilized, for solution	64538-180BULK INGREDIENT
-	epcoritamab-bysp	injection	64538-002BULK INGREDIENT
-	ustekinumab-aauz	injection	64538-824BULK INGREDIENT

Neighbours

Registered in the same town

Nitto Denko Avecia Inc.Milford, MA

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Enquiry

Common questions

Is Rentschler Biopharma SE FDA approved?: Rentschler Biopharma SE holds 2 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 Rentschler Biopharma SE's drugs manufactured?: At registered sites in Germany, the United States. The FDA register lists Laupheim; Milford, MA. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
What drugs does Rentschler Biopharma SE make?: 8 products are listed under Rentschler Biopharma SE in the openFDA NDC Directory, most often as injection; injection, solution; injection, powder, lyophilized, for solution. 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.