Panacea Biotec receives USFDA nod for Azacitidine inj

The company's oncology parenteral formulation plant at Baddi, Himachal Pradesh received the US drug regulators approval for the supply of Azacitidine injection, 100 mg/vial to the US market. Reacting to the development, the stock of Panacea Biotec was buzzing in the early morning session on Tuesday.

The United States Food & Drug Administration (USFDA) has approved the manufacture and supply of Azacitidine injection at Panacea Biotec's Baddi facility, which is already approved by the National Regulatory Authority (NRA) of India and USFDA for various oral solids and injectable products.

Azacitidine is a chemotherapy drug used to treat myelodysplastic syndromes (MDS). The drug is a generic equivalent of Vidaza, marketed by Celgene Corp, US. It has an annual sales of approximately US$110 million in the US, according to IQVIA data until December, 2018.

The company is manufacturing the drug under a three-way partnership with Natco Pharma and Breckenridge Pharmaceutical Inc. USA, which has an existing approved ANDA for 100mg/vial Azacitidine injection. Also, Natco has recently received USFDA approval for the supplemental abbreviated new drug application (sANDA) for the drug.

At 9:54 hours, the stock of Panacea Biotec was quoting Rs. 202.30 per share, up by Rs. 10.30 or 5.36 per cent on BSE.