Aurobindo Pharma's Subsidiary Receives GMP From European Medicines Agency For Biosimilars Facility
CuraTeQ Biologics' EMA GMP certification marks a key milestone in Aurobindo Pharma's expansion into biosimilars, with three products under review for European approval in oncology and immunology.
CuraTeQ Biologics Pvt., an Aurobindo Pharma subsidiary, was given a Good Manufacturing Practice certificate of compliance for its biosimilars manufacturing facility from the European Medicines Association on Tuesday.
"The EU GMP certification marks a significant milestone in CuraTeQ's commitment to manufacturing high-quality biosimilars for patients worldwide. This inspection outcome paves way for securing approvals for our three biosimilars in Europe, currently under review by the Agency, within the next two to five months." Satakarni Makkapati, director of Aurobindo Pharma Ltd. and chief executive officer of biologics, vaccines, and peptides, stated.
The GMP inspection was conducted by EMA representatives from April 8 to April 12, 2024.
It evaluated mammalian and microbial drug substance manufacturing facility sections, prefilled syringes and vials filling, packaging, and quality control testing and release laboratories.
"Our portfolio comprises fourteen biosimilars in development across oncology and immunology segments. We are dedicated to building a sustainable biosimilars portfolio and bringing these essential therapies to patients," Mr. K. Nithyananda Reddy, vice chairman and managing director of Aurobindo Pharma Ltd., added.
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Aurobindo Pharma Ltd. reported an 8% year-on-year increase in its second-quarter profit, reaching Rs 817 crore for the quarter ending Sept. 30, 2024. However, the result fell short of analysts' expectations, with the consensus estimate pegged at Rs 972 crore, according to data from Bloomberg.
Shares of Aurobindo Pharma Ltd. closed 2.41 % lower at Rs 1 apiece on the NSE, compared to a 1.07% lower in the benchmark Nifty 50.
The stock had 16.92% on a year-to-date basis and 29.37% over the past 12 months.
The stock had an intraday low of 2.41% at Rs 1,258 per share.
Out of the 29 analysts tracking the company, 20 have a 'buy' rating on the stock, five suggest a 'hold' and four recommend 'sell', according to Bloomberg data.
The average of 12-month analysts' consensus price targets implies a potential upside of 22.5%.
