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news.Alembic Pharmaceuticals has entered into a license agreement with Accu-Break Pharmaceuticals (ABP) to develop new brand products that will use ABP's Accu-Break tablet technologies.
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ABP said its patented Accu-Break tablets can be split easily by hand into exact smaller doses, which will make it easier and safer for patients and caregivers to adjust their dosage.
ABP will seek the US Food and Drug Administration approval for its first anticoagulant medication warfarin (Coumadin) product.
Accu-Break Pharmaceuticals executive chairman Elliot Hahn said the company is delighted to be working with a pharmaceutical company in India that is vertically integrated and has the ability and expertise to develop and manufacture pharmaceutical products for the US market.
"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," Hahn added.