Panacea Biotec's Oncology Parenteral Formulation Facility at Baddi, Himachal Pradesh, India, 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.
Panacea Biotec had earlier entered into a tripartite agreement with Natco Pharma Ltd. ("Natco") and Breckenridge Pharmaceutical Inc. USA ("Breckenridge") 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. The supplemental abbreviated new drug application (sANDA) submitted by Natco as "Prior Approval Supplement" has recently been approved by the USFDA.
Azacitidine is a chemotherapy drug used to treat myelodysplastic syndromes (MDS) with annual sales of about USD 110 Mn in US markets as per IQVIA data as of December, 2018.
Shares of PANACEA BIOTEC LTD. was last trading in BSE at Rs.192 as compared to the previous close of Rs. 184.75. The total number of shares traded during the day was 4830 in over 277 trades.
The stock hit an intraday high of Rs. 196.75 and intraday low of 190. The net turnover during the day was Rs. 937990.