Is Tris Pharma, Inc. FDA approved?

Tris Pharma, 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 Tris Pharma, Inc.'s drugs manufactured?

The FDA register lists Cranbury, NJ; Monmouth Junction, NJ. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does Tris Pharma, Inc. make?

20 products are listed under Tris Pharma, Inc. in the openFDA NDC Directory, most often as capsule; tablet; tablet, extended release. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Tris Pharma, Inc.

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

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Registered sites: 2
Active NDC listings: 20
Live patents: 32
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture2Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Tris Pharma, Inc.	102 Melrich Rd, Cranbury, New Jersey (NJ) 08512-3520, United States (USA)	Finished drug manufacture	3008079002809003473
Tris Pharma Inc	2033 Route 130 South Suite D, Monmouth Junction, New Jersey (NJ) 08852, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3004712471947472119

Catalogue

Drug listings by form and route

20 active NDC listings: 20 human prescription drug. By marketing category: ANDA 20.

Dosage form	NDCs
capsule	7
tablet	6
tablet, extended release	4
solution	2
syrup	1

Route	NDCs
oral	20

Labeller name on the listing	NDCs
tris pharma inc	20

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
10086087	DYANAVEL XRamphetamine; amphetamine aspartate/dextroamphetamine sulfate	product	Mar 2027
8337890	DYANAVEL XR 10, DYANAVEL XR 15, DYANAVEL XR 20, DYANAVEL XR 5amphetamine; amphetamine aspartate/dextroamphetamine sulfate	product	Mar 2027
8597684	DYANAVEL XRamphetamine; amphetamine aspartate/dextroamphetamine sulfate	product	Mar 2027
8747902	DYANAVEL XR, DYANAVEL XR 10, DYANAVEL XR 15, DYANAVEL XR 20, DYANAVEL XR 5amphetamine; amphetamine aspartate/dextroamphetamine sulfate	product	Mar 2027
8790700	TUZISTRA XRchlorpheniramine polistirex; codeine polistirex	product	Mar 2027
8883217	DYANAVEL XRamphetamine; amphetamine aspartate/dextroamphetamine sulfate	product	Mar 2027
9675703	DYANAVEL XRamphetamine; amphetamine aspartate/dextroamphetamine sulfate	product	Mar 2027
9675704	DYANAVEL XR 10, DYANAVEL XR 15, DYANAVEL XR 20, DYANAVEL XR 5amphetamine; amphetamine aspartate/dextroamphetamine sulfate	product	Mar 2027
8062667	DYANAVEL XR, ONYDA XR, TUZISTRA XRamphetamine; amphetamine aspartate/dextroamphetamine sulfate; chlorpheniramine polistirex; codeine polistirex; clonidine hydrochloride	product	Mar 2029
11590228	DYANAVEL XRamphetamine; amphetamine aspartate/dextroamphetamine sulfate	product	Sept 2036
11590081	DYANAVEL XR 10, DYANAVEL XR 15, DYANAVEL XR 20, DYANAVEL XR 5amphetamine; amphetamine aspartate/dextroamphetamine sulfate	product	Sept 2038
12458592	DYANAVEL XR 10, DYANAVEL XR 15, DYANAVEL XR 20, DYANAVEL XR 5amphetamine; amphetamine aspartate/dextroamphetamine sulfate	use	Feb 2040
11918689	ONYDA XRclonidine hydrochloride	product	Jul 2041
12576032	ONYDA XRclonidine hydrochloride	use	Jul 2041

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Cyproheptadine Hydrochloride	Cyproheptadine Hydrochloride	syrup, oral	27808-099ANDA
Febuxostat	febuxostat	tablet, oral	27808-206ANDA
Febuxostat	febuxostat	tablet, oral	27808-207ANDA
Lacosamide	Lacosamide	tablet, oral	27808-243ANDA
Lacosamide	Lacosamide	tablet, oral	27808-244ANDA
Lacosamide	Lacosamide	tablet, oral	27808-245ANDA
Lacosamide	Lacosamide	tablet, oral	27808-246ANDA
Paliperidone	paliperidone	tablet, extended release, oral	27808-222ANDA
Paliperidone	paliperidone	tablet, extended release, oral	27808-223ANDA
Paliperidone	paliperidone	tablet, extended release, oral	27808-224ANDA
Paliperidone	paliperidone	tablet, extended release, oral	27808-225ANDA
Potassium Chloride	Potassium Chloride	solution, oral	27808-168ANDA
Potassium Chloride	Potassium Chloride	solution, oral	27808-169ANDA
Pregabalin	Pregabalin	capsule, oral	27808-235ANDA
Pregabalin	Pregabalin	capsule, oral	27808-236ANDA
Pregabalin	Pregabalin	capsule, oral	27808-237ANDA
Pregabalin	Pregabalin	capsule, oral	27808-238ANDA
Pregabalin	Pregabalin	capsule, oral	27808-239ANDA
Pregabalin	Pregabalin	capsule, oral	27808-240ANDA
Pregabalin	Pregabalin	capsule, oral	27808-241ANDA

Neighbours

Registered in the same town

WuXi Biologics Co., Ltd.Cranbury, NJ · 2 sites
Taikun Pharmaceutical Technology IncCranbury, NJ
Endo USA, Inc.Cranbury, NJ
SciSafe, Inc.Cranbury, NJ
CMIC CMO USA CORPORATIONCranbury, NJ
David WoodCranbury, NJ
E-BEAM Services, Inc.Cranbury, NJ
J-star Research Inc.Cranbury, NJ
Primera Analytical Solutions CorporationCranbury, NJ
Alliance Technologies, LLCMonmouth Junction, NJ
Amerise Pharmaceuticals LLCCranbury, NJ
Cranbury Pharmaceuticals IncMONMOUTH JUNCTION, NJ

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Enquiry

Common questions

Is Tris Pharma, Inc. FDA approved?: Tris Pharma, 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 Tris Pharma, Inc.'s drugs manufactured?: The FDA register lists Cranbury, NJ; Monmouth Junction, NJ. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Tris Pharma, Inc. make?: 20 products are listed under Tris Pharma, Inc. in the openFDA NDC Directory, most often as capsule; tablet; 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.