Panacea Biotec, Natco Pharma Ltd. & Breckenridge Pharmaceutical Inc. inks Tripartite Agreement for manufacturing and supply of Azacitidine injection
Deepthi | Myequity news | Date : 27-08-2018 19:30:00 IST
Panacea Biotec, one of India's leading research based pharmaceutical and biotechnology companies, has entered into a tripartite agreement with Natco Pharma Ltd. ("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 Breckenridge 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).
Speaking on the occasion 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 "About Panacea Biotec:
Panacea Biotec is a leading pharmaceutical and biotechnology company with established Research, Manufacturing and Marketing capabilities. The Company has been awarded twice (for 2015 & 2016) with the 'prestigious "India Innovation Award 2016 - Top 50" by Clarivate Analytics (Thomson Reuters). The company's state-of-the-art manufacturing facilities for vaccines and pharmaceutical formulations comply with standards laid down by several leading regulatory agencies worldwide. The company has around 3000 employees including around 100 scientists working across 4 R&D centers of the Company.
The product portfolio of includes highly innovative products in therapeutic areas of oncology, organ transplantation, nephrology, diabetes, osteoporosis, cardiovascular diseases and pediatric vaccines. It is working on a robust pipeline of high barrier to entry generics products, thus leveraging its capabilities in the areas of nanotechnology and platform drug delivery technologies like micro-particles, liposomes, gastro- retentive systems. It has introduced its products in around 30 countries across the world, including USA, Germany and Russian Federation, through a combination of strategic collaborations and direct presence in select geographies. The Company has research -collaborations with leading national and international research organizations and corporations.