Panacea Biotec has received United States Food & Drug Administration (USFDA) approval for manufacture and supply of Azacitidine Injection, 100 mg/vial, 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.
Azacitidine is a chemotherapy drug used to treat myelodysplastic syndromes (MDS) with annual sales of about $110 million in US markets as per IQVIA data as of December, 2018.
Panacea Biotec is a leading research based Biotechnology Company with established research, manufacturing and marketing capabilities. It is one of the largest vaccine producers and biotechnology companies in India.