Is ONY Biotech Inc. FDA approved?

ONY Biotech 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 ONY Biotech Inc.'s drugs manufactured?

The FDA register lists Amherst, NY; Madera, CA. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, sterilize.

What drugs does ONY Biotech Inc. make?

1 product is listed under ONY Biotech Inc. in the openFDA NDC Directory, most often as suspension. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

ONY Biotech Inc.

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

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Registered sites: 2
Active NDC listings: 1
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture2Labelling1Finished drug manufacture1Packaging1sterilize1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
ONY Biotech Inc.	1576 Sweet Home Road, Amherst, New York (NY) 14228, United States (USA)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging, sterilize	1319086622369833
ONY Biotech Inc.	335 S. Schnoor Ave, Ste 133, Madera, California (CA) 93637, United States (USA)	Active ingredient (API) manufacture	3043304847144851882

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
INFASURF	calfactant	suspension, endotracheal	61938-456BLA

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Enquiry

Common questions

Is ONY Biotech Inc. FDA approved?: ONY Biotech 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 ONY Biotech Inc.'s drugs manufactured?: The FDA register lists Amherst, NY; Madera, CA. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, sterilize.
What drugs does ONY Biotech Inc. make?: 1 product is listed under ONY Biotech Inc. in the openFDA NDC Directory, most often as suspension. 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.