Is Aspen Pharmacare Holdings Ltd. FDA approved?

Aspen Pharmacare Holdings Ltd. holds 2 FDA-registered establishments in South Africa. 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 Aspen Pharmacare Holdings Ltd.'s drugs manufactured?

The FDA register lists Port Elizabeth. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, sterilize.

Aspen Pharmacare Holdings Ltd.

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

Request a quote Claim this profile

Registered sites: 2
Active NDC listings: 0
Live patents: 0
Countries: 1
Base: South Africa

Authorisation

Registered operations

Analytical testing2Labelling2Finished drug manufacture2Packaging2sterilize1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
ASPEN SA OSD OPERATIONS (PTY) LTDRegistrant: Aspen Pharmacare Holdings Ltd.	CNR FAIRCLOUGH RD AND GIBAUD, Port Elizabeth, EASTERN CAPE 6020, South Africa (ZAF)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3003692704538962655
ASPEN SA STERILE OPERATIONS (PTY) LTDRegistrant: Aspen Pharmacare Holdings Ltd.	8B Gibaud Road, Port Elizabeth, EASTERN CAPE 6020, South Africa (ZAF)	Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize	3007490529569162139

Compare

Comparable companies in South Africa

Fine Chemicals Corporation (PTY) Ltd.1 site · 16 NDC

Enquiry

Common questions

Is Aspen Pharmacare Holdings Ltd. FDA approved?: Aspen Pharmacare Holdings Ltd. holds 2 FDA-registered establishments in South Africa. 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 Aspen Pharmacare Holdings Ltd.'s drugs manufactured?: The FDA register lists Port Elizabeth. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, sterilize.

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.