12 companies list clozapine as a human prescription drug in the openFDA NDC Directory, led by Mylan Pharmaceuticals, Inc., Aurobindo Pharma Limited, Teva Pharmaceutical Industries Ltd., Pharma Packaging Solutions, LLC dba Tjoapack, LLC, Safecor Health, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.

Is there a generic Clozaril?

10 companies list clozapine under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.

Who supplies clozapine active ingredient?

9 companies list clozapine as a bulk ingredient, including AX Pharmaceutical Corp, Aurore Pharmaceuticals Private Limited, CAMBREX PROFARMACO MILANO SRL, Cohance Lifesciences Limited.

Drug

Who makes clozapine?

12 companies list clozapine as a human prescription drug, including under the names Clozaril, VERSACLOZ. Forms: suspension; tablet; tablet, orally disintegrating. Routes: oral.

Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology

Companies listing clozapine

Company	Forms	Application	NDCs	Registered sites
Mylan Pharmaceuticals, Inc.	tablet; tablet, orally disintegrating	ANDAANDA075417, ANDA201824	8	0
Aurobindo Pharma LimitedIndia	tablet; tablet, orally disintegrating	ANDAANDA206433, ANDA212923	7	6
Teva Pharmaceutical Industries Ltd.Canada	tablet, orally disintegrating	ANDAANDA090308	5	6
Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States	tablet	ANDAANDA206433	4	5
Safecor Health, LLCUnited States	tablet; tablet, orally disintegrating	ANDAANDA075417, ANDA201824	4	3
MAJOR Pharmaceuticals Inc.	tablet	ANDAANDA206433	4	0
Mylan Institutional Inc.	tablet; tablet, orally disintegrating	ANDAANDA075417, ANDA201824	4	0
Northstar Rx, LLC,	tablet	ANDAANDA206433	4	0
ACCORD HEALTHCARE LIMITEDUnited Kingdom	tablet	ANDAANDA202873	2	2
HLS Therapeutics (USA), IncUnited States	tablet	NDANDA019758	2	1
Cardinal Health 418, Inc.United States	tablet	ANDAANDA206433	1	34
TruPharma LLC.	suspension	NDANDA203479	1	0

Bulk ingredient listings

AX Pharmaceutical CorpCanada · 1 NDC
Aurore Pharmaceuticals Private LimitedIndia · 1 NDC
CAMBREX PROFARMACO MILANO SRLItaly · 1 NDC
Cohance Lifesciences LimitedIndia · 1 NDC
Matrix Pharmacorp Private LimitedIndia · 1 NDC
Medichem SASpain · 1 NDC
R.L.Fine Chem Private LimitedIndia · 1 NDC
SMS Pharmaceuticals LimitedIndia · 1 NDC
Shouguang Fukang Phamaceutical Co., Ltd. · 1 NDC

Orange Book patents

1 unexpired patent lists clozapine as the active ingredient, expiring between May 2028 and May 2028. Application holder: DOUGLAS PHARMACEUTICALS AMERICA LTD.

Enquiry

Common questions

Who makes clozapine?: 12 companies list clozapine as a human prescription drug in the openFDA NDC Directory, led by Mylan Pharmaceuticals, Inc., Aurobindo Pharma Limited, Teva Pharmaceutical Industries Ltd., Pharma Packaging Solutions, LLC dba Tjoapack, LLC, Safecor Health, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
Is there a generic Clozaril?: 10 companies list clozapine under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
Who supplies clozapine active ingredient?: 9 companies list clozapine as a bulk ingredient, including AX Pharmaceutical Corp, Aurore Pharmaceuticals Private Limited, CAMBREX PROFARMACO MILANO SRL, Cohance Lifesciences Limited.