Is BioSpectra Inc. FDA approved?

BioSpectra 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 BioSpectra Inc.'s drugs manufactured?

The FDA register lists Bangor, PA; Stroudsburg, PA. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.

What drugs does BioSpectra Inc. make?

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

BioSpectra Inc.

Data as of 28 Sept 2026 · How to read this entry

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Registered sites: 2
Active NDC listings: 3
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing2Active ingredient (API) manufacture1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
BioSpectra Inc.	100 Majestic Way, Bangor, Pennsylvania (PA) 18013, United States (USA)	Analytical testing, Active ingredient (API) manufacture	3010476065042724830
BioSpectra Inc.	1474 Rockdale Lane, Stroudsburg, Pennsylvania (PA) 18360, United States (USA)	Analytical testing, Finished drug manufacture	3003380159957030729

Catalogue

Drug listings by form and route

3 active NDC listings: 3 bulk ingredient. By marketing category: BULK INGREDIENT 3.

Dosage form	NDCs
crystal	3

Route	NDCs

Labeller name on the listing	NDCs
biospectra	3

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Potassium Bromide	crystal	64173-203BULK INGREDIENT
-	Tromethamine	crystal	64173-101BULK INGREDIENT
-	Tromethamine	crystal	64173-204BULK INGREDIENT

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Enquiry

Common questions

Is BioSpectra Inc. FDA approved?: BioSpectra 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 BioSpectra Inc.'s drugs manufactured?: The FDA register lists Bangor, PA; Stroudsburg, PA. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
What drugs does BioSpectra Inc. make?: 3 products are listed under BioSpectra Inc. in the openFDA NDC Directory, most often as crystal. 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.