Is Stemline Therapeutics, Inc. FDA approved?

Stemline Therapeutics, Inc. holds 1 FDA-registered establishment in Germany. 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 Stemline Therapeutics, Inc.'s registered sites?

The FDA register lists Berlin. Registered operations: analytical testing.

What drugs does Stemline Therapeutics, Inc. make?

3 products are listed under Stemline Therapeutics, Inc. in the openFDA NDC Directory, most often as tablet, film coated; injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Stemline Therapeutics, Inc.

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

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Registered sites: 1
Active NDC listings: 3
Live patents: 12
Exclusivities: 1
Countries: 1
Base: Germany

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
A. Menarini Research & Business Service GmbHRegistrant: Stemline Therapeutics, Inc.	Glenicker Weg 125, Berlin, Berlin 12489, Germany (DEU)	Analytical testing	3010666018312857236

Catalogue

Drug listings by form and route

3 active NDC listings: 3 human prescription drug. By marketing category: NDA 2, BLA 1.

Dosage form	NDCs
tablet, film coated	2
injection, solution	1

Route	NDCs
oral	2
intravenous	1

Labeller name on the listing	NDCs
stemline therapeutics, inc.	3

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10071066	ORSERDUelacestrant hydrochloride	use	Oct 2034
11779552	ORSERDUelacestrant hydrochloride	use	Oct 2034
10420734	ORSERDUelacestrant hydrochloride	use	Oct 2036
11819480	ORSERDUelacestrant hydrochloride	use	Feb 2037
10385008	ORSERDUelacestrant hydrochloride	substance, product	Jan 2038
10745343	ORSERDUelacestrant hydrochloride	use	Jan 2038

Product	Exclusivity	Until
ORSERDUELACESTRANT HYDROCHLORIDE	NCE New chemical entity	Jan 2028

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Elzonris	tagraxofusp	injection, solution, intravenous	72187-0401BLA
ORSERDU	Elacestrant	tablet, film coated, oral	72187-0101NDA
ORSERDU	Elacestrant	tablet, film coated, oral	72187-0102NDA

Neighbours

Registered in the same town

Bayer Healthcare Manufacturing SrlBerlin, DEU · 2 sites
SGS North America Inc.Berlin, DEU
Novatech SABerlin, DEU
Eckert & Ziegler Radiopharma GmbHBerlin, DEU
Klosterfrau Berlin GmbHBerlin, DEU

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Enquiry

Common questions

Is Stemline Therapeutics, Inc. FDA approved?: Stemline Therapeutics, Inc. holds 1 FDA-registered establishment in Germany. 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 Stemline Therapeutics, Inc.'s registered sites?: The FDA register lists Berlin. Registered operations: analytical testing.
What drugs does Stemline Therapeutics, Inc. make?: 3 products are listed under Stemline Therapeutics, Inc. in the openFDA NDC Directory, most often as tablet, film coated; injection, 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.