Is Aucta Pharmaceuticals, Inc. FDA approved?

Aucta Pharmaceuticals, Inc. holds 2 FDA-registered establishments in the United States. 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 Aucta Pharmaceuticals, Inc.'s drugs manufactured?

The FDA register lists Basking Ridge, NJ; Piscataway, NJ. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does Aucta Pharmaceuticals, Inc. make?

8 products are listed under Aucta Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as capsule, extended release; powder, for solution; granule, for solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Aucta Pharmaceuticals, Inc.

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

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Registered sites: 2
Active NDC listings: 8
Live patents: 9
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing2Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Aucta Pharmaceuticals, Inc.	170 Mount Airy Rd, Basking Ridge, New Jersey (NJ) 07920, United States (USA)	Analytical testing	3029416323119058320
Aucta Pharmaceuticals, Inc.	71 Suttons Lane, Piscataway, New Jersey (NJ) 08854, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3015204529016894249

Catalogue

Drug listings by form and route

8 active NDC listings: 8 human prescription drug. By marketing category: ANDA 5, NDA 3.

Dosage form	NDCs
capsule, extended release	3
powder, for solution	2
granule, for solution	1
solution	1
suspension	1

Route	NDCs
oral	7
respiratory (inhalation)	1

Labeller name on the listing	NDCs
aucta pharmaceuticals, inc.	8

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
11337943	MOTPOLY XRlacosamide	product	Jun 2040
11883374	MOTPOLY XRlacosamide	product	Jun 2040
12042474	MOTPOLY XRlacosamide	product	Jun 2040

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Arformoterol Tartrate Inhalation Solution	Arformoterol Tartrate	solution, respiratory (inhalation)	73289-0072ANDA
Fosfomycin Tromethamine	Fosfomycin tromethamine	granule, for solution, oral	73289-0067ANDA
MOTPOLY XR	lacosamide	capsule, extended release, oral	73289-0063NDA
MOTPOLY XR	lacosamide	capsule, extended release, oral	73289-0064NDA
MOTPOLY XR	lacosamide	capsule, extended release, oral	73289-0065NDA
PYQUVI	deflazacort	suspension, oral	73289-0089ANDA
ZELVYSIA	SAPROPTERIN DIHYDROCHLORIDE	powder, for solution, oral	73289-0070ANDA
ZELVYSIA	sapropterin dihydrochloride	powder, for solution, oral	73289-0071ANDA

Neighbours

Registered in the same town

Amneal Pharmaceuticals of New York, LLCPiscataway, NJ
MSN Laboratories Private Limited,Piscataway, NJ
Coglate-Palmolive CompanyPiscataway, NJ
L'Oreal USA Products IncPISCATAWAY, NJ
Kashiv BioSciences, LLCPiscataway, NJ
APPCO PHARMA LLCPiscataway, NJ
Camber Consumer Care IncPiscataway, NJ
Camber Pharmaceuticals, Inc.PISCATAWAY, NJ
Medcore llcBasking Ridge, NJ

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Enquiry

Common questions

Is Aucta Pharmaceuticals, Inc. FDA approved?: Aucta Pharmaceuticals, Inc. holds 2 FDA-registered establishments in the United States. 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 Aucta Pharmaceuticals, Inc.'s drugs manufactured?: The FDA register lists Basking Ridge, NJ; Piscataway, NJ. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Aucta Pharmaceuticals, Inc. make?: 8 products are listed under Aucta Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as capsule, extended release; powder, for solution; granule, 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.