Is Nova Biologicals, Inc. FDA approved?

Nova Biologicals, Inc. 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 Nova Biologicals, Inc.'s drugs manufactured?

At registered sites in the United Kingdom, the United States. The FDA register lists Wigston; Conroe, TX. Registered operations: analytical testing, finished drug manufacture.

What drugs does Nova Biologicals, Inc. make?

3 products are listed under Nova Biologicals, Inc. in the openFDA NDC Directory, most often as suspension; solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Nova Biologicals, Inc.

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

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Registered sites: 2
Active NDC listings: 3
Labeller names: 2
Live patents: 1
Exclusivities: 1
Countries: 2
Base: United States

Authorisation

Registered operations

Analytical testing1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Nova Laboratories Ltd	Gloucester Cresent, Wigston, Leicestershire LE18 4YL, United Kingdom (GBR)	Finished drug manufacture	3000323524230804692
Nova Biologicals, Inc.	1775 N Loop 336 E, Ste 4, Conroe, Texas (TX) 77301, United States (USA)	Analytical testing	1641521802721324

Catalogue

Drug listings by form and route

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

Dosage form	NDCs
suspension	2
solution	1

Route	NDCs
oral	3

Labeller name on the listing	NDCs
nova laboratories, ltd	2
nova laboratories, ltd.	1

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
12409156	XROMIhydroxyurea	product	Dec 2041

Product	Exclusivity	Until
XROMIHYDROXYUREA	ODE-470 Orphan drug	Apr 2031

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
MERCAPTOPURINE	MERCAPTOPURINE	suspension, oral	62484-1020NDA AUTHORIZED GENERIC
PURIXAN	Purixan	suspension, oral	62484-0020NDA
XROMI	Hydroxyurea	solution, oral	62484-0015NDA

Neighbours

Registered in the same town

Atlantis Laboratories, Inc.Conroe, TX

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Enquiry

Common questions

Is Nova Biologicals, Inc. FDA approved?: Nova Biologicals, Inc. 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 Nova Biologicals, Inc.'s drugs manufactured?: At registered sites in the United Kingdom, the United States. The FDA register lists Wigston; Conroe, TX. Registered operations: analytical testing, finished drug manufacture.
What drugs does Nova Biologicals, Inc. make?: 3 products are listed under Nova Biologicals, Inc. in the openFDA NDC Directory, most often as suspension; 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.