India-based Accu-Break Pharmaceuticals (ABP) has entered into a development and license agreement with Alembic Pharmaceuticals of Plantation, Fla., to develop new brand products that will use ABP’s innovative Accu-Break tablet technologies.
ABP’s patented Accu-Break tablets can be split easily by hand into exact smaller doses to provide maximum flexibility, and to make it easier and safer for patients and caregivers to adjust their dosage. The first product that ABP will seek FDA marketing approval for is an Accu-Break-formatted version of the popular anticoagulant medication warfarin (Coumadin).
“We are delighted to be working with a leading pharmaceutical company in India that is vertically integrated and has the ability and expertise to develop and manufacture pharmaceutical products for the U.S. market,” said Elliot F. Hahn, Ph.D., executive chairman of ABP. “Together, we are looking forward to filing the first of what we anticipate will be many 505(b)(2) New Drug Applications for products utilizing our patented Accu-Break technologies in combination with Alembic’s broad base of active pharmaceutical ingredients and formulations.”