Mumbai, May 22: Pharma Major, Panacea Biotec said that company's Formulation Facility at Baddi, Himachal Pradesh has received United States Food & Drug Administration (USFDA) approval for manufacture and supply of Azacitidine Injection for the US market.
Panacea Biotec's state-of-the-art pharmaceutical formulation facility at Baddi is already approved by National Regulatory Authority (NRA) of India and USFDA for other oral solids and injectable products, company said in a filing with BSE.
Panacea Biotec had earlier entered into a tripartite agreement with Natco Pharma Ltd and Breckenridge Pharmaceutical Inc. USA for manufacturing and supply thereof for the US market under Breckenridge's existing approved ANDA for Azacitidine for Injection 100mg/vial, generic equivalent of Vidaza, marketed by Celgene Corp, US.
Azacitidine is a chemotherapy drug used to treat myelodysplastic syndromes (MDS) with annual sales of about USD 110 Million in US markets as per IQVIA data as of December, 2018. UNI