16 companies list dasatinib as a human prescription drug in the openFDA NDC Directory, led by Alembic Pharmaceuticals Limited, Lupin Limited, Zydus Lifesciences Limited, Biocon Biologics Limited, Apotex Inc.. 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 PHYRAGO?

13 companies list dasatinib 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 dasatinib active ingredient?

8 companies list dasatinib as a bulk ingredient, including Hetero Labs Limited, MSN Laboratories Private Limited,, Aurobindo Pharma Limited, CIPLA PHARMACEUTICALS LIMITED.

Drug

Who makes dasatinib?

16 companies list dasatinib as a human prescription drug, including under the names PHYRAGO, SPRYCEL. 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 dasatinib

Company	Forms	Application	NDCs	Registered sites
Alembic Pharmaceuticals LimitedIndia	tablet, film coated	ANDAANDA216261	12	7
Lupin LimitedIndia	tablet	ANDAANDA214350	6	14
Zydus Lifesciences LimitedIndia	tablet	ANDAANDA218719	6	12
Biocon Biologics LimitedIndia	tablet, film coated	ANDAANDA217217	6	9
Apotex Inc.Canada	tablet, film coated	ANDAANDA202103, ANDA203180	6	6
Aurobindo Pharma LimitedIndia	tablet	ANDAANDA216547	6	6
Teva Pharmaceutical Industries Ltd.Canada	tablet, film coated	ANDAANDA211094	6	6
Zydus Pharmaceuticals USA Inc.India	tablet	ANDAANDA218719	6	1
AvKARE	tablet, film coated	ANDAANDA211094	6	0
BluePoint Laboratories Inc.	tablet, film coated	ANDAANDA217217	6	0
Cycle Pharmaceuticals Ltd-Uk	tablet	NDANDA216099	6	0
Dr. Reddys Laboratories Limited	tablet, film coated	ANDAANDA213383	6	0
E.R. Squibb & Sons, L.L.C.	tablet	NDANDA021986	6	0
NorthStar RxLLC	tablet, film coated	ANDAANDA216261	6	0
Novadoz Pharmaceuticals LLC	tablet	ANDAANDA219579	6	0
Prasco Laboratories	tablet	NDA AUTHORIZED GENERICNDA021986	6	0

Bulk ingredient listings

Hetero Labs LimitedIndia · 2 NDC
MSN Laboratories Private Limited,India · 2 NDC
Aurobindo Pharma LimitedIndia · 1 NDC
CIPLA PHARMACEUTICALS LIMITEDIndia · 1 NDC
Granules Pharmaceuticals Inc.India · 1 NDC
Hubei Haosun Pharmaceutical Co., Ltd.China · 1 NDC
SK BIOTEKIreland · 1 NDC
Sun Pharmaceutical Industries LimitedIndia · 1 NDC

Orange Book patents

7 unexpired patents list dasatinib as the active ingredient, expiring between Sept 2026 and Jan 2041. Application holders: BRISTOL MYERS SQUIBB CO, HANDA THERAPEUTICS LLC.

Enquiry

Common questions

Who makes dasatinib?: 16 companies list dasatinib as a human prescription drug in the openFDA NDC Directory, led by Alembic Pharmaceuticals Limited, Lupin Limited, Zydus Lifesciences Limited, Biocon Biologics Limited, Apotex Inc.. 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 PHYRAGO?: 13 companies list dasatinib 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 dasatinib active ingredient?: 8 companies list dasatinib as a bulk ingredient, including Hetero Labs Limited, MSN Laboratories Private Limited,, Aurobindo Pharma Limited, CIPLA PHARMACEUTICALS LIMITED.