Is Ambiopharm, Inc. FDA approved?

Ambiopharm, 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 Ambiopharm, Inc.'s drugs manufactured?

The FDA register lists North Augusta, SC. Registered operations: analytical testing, active ingredient (API) manufacture.

What drugs does Ambiopharm, Inc. make?

11 products are listed under Ambiopharm, 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.

Ambiopharm, Inc.

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

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Registered sites: 1
Active NDC listings: 11
Labeller names: 2
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Ambiopharm, Inc.	1024 Dittman Court, North Augusta, South Carolina (SC) 29842, United States (USA)	Analytical testing, Active ingredient (API) manufacture	3006446551830014747

Catalogue

Drug listings by form and route

11 active NDC listings: 11 bulk ingredient. By marketing category: BULK INGREDIENT 11.

Dosage form	NDCs
powder	11

Route	NDCs

Labeller name on the listing	NDCs
ambiopharm, inc.	9
ambiopharm, inc.	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Cetrorelix	powder	41524-0013BULK INGREDIENT
-	Eptifibatide	powder	41524-0002BULK INGREDIENT
-	Exenatide	powder	41524-0003BULK INGREDIENT
-	Glatiramer	powder	41524-0004BULK INGREDIENT
-	Glucagon	powder	41524-0005BULK INGREDIENT
-	Icatibant Acetate	powder	41524-0008BULK INGREDIENT
-	Leuprolide	powder	41524-0006BULK INGREDIENT
-	Octreotide	powder	41524-0007BULK INGREDIENT
-	Plecanatide	powder	41524-0014BULK INGREDIENT
-	Teriparatide	powder	41524-0010BULK INGREDIENT
-	bivalirudin	powder	41524-0001BULK INGREDIENT

Neighbours

Registered in the same town

Halocarbon Life Sciences, LLCNorth Augusta, SC

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Enquiry

Common questions

Is Ambiopharm, Inc. FDA approved?: Ambiopharm, 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 Ambiopharm, Inc.'s drugs manufactured?: The FDA register lists North Augusta, SC. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does Ambiopharm, Inc. make?: 11 products are listed under Ambiopharm, 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.