Tuesday, 21 May 2019

Panacea Biotec gains 9% on USFDA approval for Azacitidine Injection

The 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.


Share price of Panacea Biotec added more than 9 percent in the early trade on Tuesday after company received USFDA approval for Azacitidine Injection.

The company'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.

The 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 USD 110 million in US markets, as per IQVIA data as of December, 2018.

The meeting of the board of directors of the company is scheduled on May 30 to consider and approve the audited financial results for the quarter / financial year ended 31.03.2019.

At 09:42 hrs Panacea Biotec was quoting at Rs 203.20, up Rs 11.20, or 5.83 percent on the BSE.

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