Is HLS Therapeutics (USA), Inc FDA approved?

HLS Therapeutics (USA), 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 HLS Therapeutics (USA), Inc's registered sites?

The FDA register lists Rosemont, PA. Registered operations: labelling.

What drugs does HLS Therapeutics (USA), Inc make?

2 products are listed under HLS Therapeutics (USA), Inc in the openFDA NDC Directory, most often as tablet. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

HLS Therapeutics (USA), Inc

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

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

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
HLS Therapeutics (USA), Inc.Registrant: HLS Therapeutics (USA), Inc	919 Conestoga Road, Building Three, Suite 310, Rosemont, Pennsylvania (PA) 19010, United States (USA)	Labelling	3013003512079808066

Catalogue

Drug listings by form and route

2 active NDC listings: 2 human prescription drug. By marketing category: NDA 2.

Dosage form	NDCs
tablet	2

Route	NDCs
oral	2

Labeller name on the listing	NDCs
hls therapeutics (usa), inc.	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Clozaril	clozapine	tablet, oral	69809-0126NDA
Clozaril	clozapine	tablet, oral	69809-0127NDA

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Common questions

Is HLS Therapeutics (USA), Inc FDA approved?: HLS Therapeutics (USA), 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 HLS Therapeutics (USA), Inc's registered sites?: The FDA register lists Rosemont, PA. Registered operations: labelling.
What drugs does HLS Therapeutics (USA), Inc make?: 2 products are listed under HLS Therapeutics (USA), Inc in the openFDA NDC Directory, most often as tablet. 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.