The capsule is used in the treatment of mantle cell lymphoma (MCL) in adults who have received at least one previous treatment for their cancer. Mantle cell lymphoma is a type of blood cancer that affects white blood cells.
Acalabrutinib Capsules are also used for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
As per IQVIA data, for the 12-month period that ended in September 2022, the Acalabrutinib Capsules, 100 mg, have an estimated market size of $1.5 billion in the United States.
The Vadodara-based pharmaceutical company has received a cumulative total of 180 ANDA approvals from the USFDA, of which 157 are final approvals and 23 are tentative ones.
Last month, the company received the first approval from the USFDA for its Jarod Facility’s formulation division IV located in the Vadodara district of Gujarat.
The pharmaceutical firm also received the Establishment Inspection Report (EIR) for its oncology injectable formulation facility in Panelav, along with approval for a skin infection cream, Desonide.
Shares of Alembic Pharmaceuticals ended 0.53 percent higher at Rs 556 on Thursday.