Panacea Biotec Inks Tripartite Agreement With Natco Pharma & Breckenridge Pharma
Panacea Biotec Limited, one of India's leading research-based pharmaceutical and biotechnology companies, has entered into a tripartite agreement with Natco Pharma Limited (Natco) and Breckenridge Pharmaceutical Inc. (Breckenridge) 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 Corporation, 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 Creckenridge in the U.S.
The application (Prior Approval Supplement) for qualifying Panacea Biotec's site has been filed with the 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 -myelodysplastic syndrome (MDS), having annual sales of about $140 million USD as reported by IMS, MA T, Dee 2017.