Is there a generic Arava?

15 companies list leflunomide under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.

Who supplies leflunomide active ingredient?

8 companies list leflunomide as a bulk ingredient, including OPELLA HEALTHCARE INTERNATIONAL SAS, Alembic Pharmaceuticals Limited, CIPLA PHARMACEUTICALS LIMITED, Darmerica, LLC.

Drug

Who makes leflunomide?

16 companies list leflunomide as a human prescription drug, including under the names Arava. Forms: tablet; tablet, film coated. 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 leflunomide

Company	Forms	Application	NDCs	Registered sites
Bryant Ranch PrepackUnited States	tablet; tablet, film coated	ANDAANDA077086, ANDA212308, ANDA213652	7	1
Alembic Pharmaceuticals LimitedIndia	tablet	ANDAANDA091369	4	7
sanofi-aventis U.S. LLC	tablet, film coated	NDANDA020905	3	0
Lupin LimitedIndia	tablet, film coated	ANDAANDA211863	2	14
Zydus Lifesciences LimitedIndia	tablet, film coated	ANDAANDA212308	2	12
Apotex Inc.Canada	tablet	ANDAANDA077090	2	6
Aurobindo Pharma LimitedIndia	tablet, film coated	ANDAANDA213652	2	6
International Medication Systems, Ltd.United States	tablet, film coated	ANDAANDA212308, ANDA213652	2	3
KVK-TECH, INC.United States	tablet	ANDAANDA212453	2	2
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.United States	tablet	ANDAANDA077086	2	1
NuCare Pharmaceuticals,Inc.United States	tablet, film coated	ANDAANDA211863, ANDA212308	2	1
Zydus Pharmaceuticals USA Inc.India	tablet, film coated	ANDAANDA212308	2	1
AvKARE	tablet	ANDAANDA077090	2	0
AvPAK	tablet	ANDAANDA077090	2	0
Burel Pharmaceuticals, LLC	tablet, film coated	ANDAANDA213497	2	0
Chartwell RX, LLC.	tablet	ANDAANDA077086	2	0

Bulk ingredient listings

OPELLA HEALTHCARE INTERNATIONAL SASFrance · 2 NDC
Alembic Pharmaceuticals LimitedIndia · 1 NDC
CIPLA PHARMACEUTICALS LIMITEDIndia · 1 NDC
Darmerica, LLCUnited States · 1 NDC
Emcure Pharmaceuticals LimitedIndia · 1 NDC
Formosa Laboratories, Inc.Taiwan · 1 NDC
Maprimed S.A.Argentina · 1 NDC
Professional Compounding Centers of America dba PCCAUnited States · 1 NDC

Enquiry

Common questions

Who makes leflunomide?: 16 companies list leflunomide as a human prescription drug in the openFDA NDC Directory, led by Bryant Ranch Prepack, Alembic Pharmaceuticals Limited, sanofi-aventis U.S. LLC, Lupin Limited, Zydus Lifesciences Limited. 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 Arava?: 15 companies list leflunomide under an abbreviated new drug application (ANDA), the application type used for generics, and 1 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
Who supplies leflunomide active ingredient?: 8 companies list leflunomide as a bulk ingredient, including OPELLA HEALTHCARE INTERNATIONAL SAS, Alembic Pharmaceuticals Limited, CIPLA PHARMACEUTICALS LIMITED, Darmerica, LLC.