Is Navinta LLC FDA approved?

Navinta LLC holds 1 FDA-registered establishment 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 Navinta LLC's drugs manufactured?

The FDA register lists Ewing, NJ. Registered operations: analytical testing, active ingredient (API) manufacture.

What drugs does Navinta LLC make?

19 products are listed under Navinta LLC in the openFDA NDC Directory, most often as capsule; gel; tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Navinta LLC

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

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Registered sites: 1
Active NDC listings: 19
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Navinta LLC	1499 Lower Ferry Road, Ewing, New Jersey (NJ) 08618, United States (USA)	Analytical testing, Active ingredient (API) manufacture	3004375014130443810

Catalogue

Drug listings by form and route

19 active NDC listings: 19 human prescription drug. By marketing category: ANDA 19.

Dosage form	NDCs
capsule	3
gel	3
tablet, film coated	3
injection	2
injection, solution, concentrate	2
injection, solution	1
kit	1
liquid	1
powder, for suspension	1
tablet	1
tablet, for suspension	1

Route	NDCs
oral	10
intravenous	5
rectal	3
intramuscular	2

Labeller name on the listing	NDCs
navinta llc	19

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Benztropine Mesylate	Benztropine Mesylate	injection, intramuscular, intravenous	68475-512ANDA
Carglumic acid	Carglumic acid	tablet, for suspension, oral	68475-006ANDA
Carmustine	carmustine	kit	68475-503ANDA
Diazepam	Diazepam	gel, rectal	68475-802ANDA
Diazepam	Diazepam	gel, rectal	68475-803ANDA
Diazepam	Diazepam	gel, rectal	68475-804ANDA
Fomepizole	Fomepizole	injection, solution, intravenous	68475-510ANDA
Glycerol Phenylbutyrate	Glycerol Phenylbutyrate	liquid, oral	68475-807ANDA
Hydralazine Hydrochloride	Hydralazine Hydrochloride	injection, intramuscular, intravenous	68475-514ANDA
Maraviroc	Maraviroc	tablet, film coated, oral	68475-007ANDA
Maraviroc	Maraviroc	tablet, film coated, oral	68475-008ANDA
Miglustat	Miglustat	capsule, oral	68475-204ANDA
Penicillamine	Penicillamine	capsule, oral	68475-201ANDA
Sevelamer carbonate	Sevelamer carbonate	tablet, film coated, oral	68475-010ANDA
Sodium Phenylacetate and sodium benzoate	Sodium Phenylacetate and sodium benzoate	injection, solution, concentrate, intravenous	68475-001ANDA
Sodium phenylacetate and Sodium benzoate	Sodium phenylacetate and Sodium benzoate	injection, solution, concentrate, intravenous	68475-513ANDA
Sodium phenylbutyrate	Sodium phenylbutyrate	tablet, oral	68475-011ANDA
Trientine Hydrochloride	Trientine Hydrochloride	capsule, oral	68475-200ANDA
famotidine	famotidine	powder, for suspension, oral	68475-400ANDA

Neighbours

Registered in the same town

TCG Greenchem Inc.Ewing, NJ

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Enquiry

Common questions

Is Navinta LLC FDA approved?: Navinta LLC holds 1 FDA-registered establishment 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 Navinta LLC's drugs manufactured?: The FDA register lists Ewing, NJ. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does Navinta LLC make?: 19 products are listed under Navinta LLC in the openFDA NDC Directory, most often as capsule; gel; tablet, film coated. 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.