Is PATHEON API, INC. FDA approved?

PATHEON API, INC. 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 PATHEON API, INC.'s drugs manufactured?

The FDA register lists Florence, SC. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.

What drugs does PATHEON API, INC. make?

7 products are listed under PATHEON API, INC. in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

PATHEON API, INC.

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

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Registered sites: 1
Active NDC listings: 7
Labeller names: 4
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
PATHEON API, INC.	6173 East Old Marion Highway, Florence, South Carolina (SC) 29506, United States (USA)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	3000717636809933534

Catalogue

Drug listings by form and route

7 active NDC listings: 7 bulk ingredient. By marketing category: BULK INGREDIENT 7.

Dosage form	NDCs
powder	7

Route	NDCs

Labeller name on the listing	NDCs
patheon api, inc.	3
patheon api manufacturing, inc.	2
patheon api, inc	1
patheon api, inc	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Metaraminol Bitartrate	powder	64274-9001BULK INGREDIENT
-	Mirdametinib	powder	63482-801BULK INGREDIENT
-	OZANIMOD HYDROCHLORIDE	powder	64274-9000BULK INGREDIENT
-	Olutasidenib	powder	63482-803BULK INGREDIENT
-	Ozanimod Hydrochloride	powder	63482-800BULK INGREDIENT
-	Sotorasib	powder	63482-802BULK INGREDIENT
-	oseltamivir phosphate	powder	63482-799BULK INGREDIENT

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Enquiry

Common questions

Is PATHEON API, INC. FDA approved?: PATHEON API, INC. 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 PATHEON API, INC.'s drugs manufactured?: The FDA register lists Florence, SC. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
What drugs does PATHEON API, INC. make?: 7 products are listed under PATHEON API, INC. in the openFDA NDC Directory, most often as powder. 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.