18 Dec , 2024 By : Debdeep Gupta
Aurobindo Pharma's share price is trading higher on December 18 despite the recent news of receiving two observations from the United States Food and Drug Administration (USFDA).
At 09:22 am, Aurobindo Pharma was quoting at Rs 1,218.95, up Rs 5.50, or 0.45 percent, on the BSE.
These observations came after an inspection of the Unit-V API manufacturing facility at Apitoria Pharma, a wholly owned subsidiary, located in Pashamylaram Village, Telangana.
The inspection, conducted between December 9 and December 17, 2024, led to procedural observations. The company has indicated that it will respond to these observations within the required time frame.
Last week, the committee for Medicinal Products for Human Use (CHMP) within the European Medicines Agency (EMA) adopted a positive opinion for Zefylti (BP13, a filgrastim biosimilar) recommending the granting of marketing authorization, to the company's subsidiary, CuraTeQ Biologics.
Zefylti will be available as 30 MU/0.5 mL and 48 MU/0.5 mL and is intended for the treatment of neutropenia and the mobilization of peripheral progenitor cells (PBPCs).
Also, earlier this month, the company's wholly owned subsidiary, Eugia Pharma Specialities, received final approval from the USFDA to manufacture and market Pazopanib Tablets, 200 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Votrient Tablets, 200 mg, of Novartis Pharmaceuticals Corporation. The product is expected to be launched in Q4FY25.
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