28 August 2018 | News
Panacea Biotec has entered into a tripartite agreement for the manufacture and supply of Azacitidine injection for the U.S. market.
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Panacea Biotec, one of the India's leading research based pharmaceutical and biotechnology companies, has entered into a tripartite agreement with Natco Pharma Ltd. and Breckenridge Pharmaceutical Inc. for the manufacture and supply of Azacitidine injection for the U.S. market under Breckenridge's already approved ANDA. Azacitidine is a generic equivalent of Vidaza which is marketed by Celgene Corporateion, U.S.
As per the terms of the agreement, Natco has provided the technology for manufacturing Azacitidine to Panacea Biotec's facility located at Baddi, Himachal Pradesh, India. Panacea Biotec will be responsible for manufacture and supply of the product, which will be marketed, sold and distributed by Breckenridge in the U.S.
The application (Prior Approval Supplement) for qualifying Panacea Biotec's site has been filed with US FDA and approval is expected in due course of time.
Azacitidine is a nucleoside metabolic inhibitor indicated for the treatment of patients with the B myelodyplastic syndrome (MDS), having annual sales of about $ 140 million as reported by IMS, MAT, Dec 2017.
Speaking on the occassion, Dr. Rajesh Jain, Managing Director, Panacea Biotec said, "We are excited about the collaboration with Natco and Breckenridge on Azacitidine. This collaboration will enable the company to grow its revenues and will also ensure increased capacity utilization of our state of the art oncology plant at Baddi."