ALFA Filings
Every announcement, straight from the exchange
Reference market data from a third-party provider, updated daily. Not a valuation or a recommendation.
Announcement type
Time
9 announcements with these filters
Aurobindo Pharma received USFDA final approval for its first MDI product, Beclomethasone Dipropionate HFA Inhalation Aerosol. The US market for this segment is estimated at US$301 million.
Aurobindo Pharma's subsidiary, CuraTeQ Biologics, received ANVISA (Brazil) approval for its biosimilars manufacturing facility in Hyderabad. This approval enables supply to Brazilian and Latin American markets.
Aurobindo Pharma received final US FDA approval for Tofacitinib Tablets used in treating rheumatoid arthritis. The product will be manufactured by its subsidiary and launched immediately.
Aurobindo Pharma subsidiary CuraTeQ received CDSCO marketing approval for Bevqolva, a bevacizumab biosimilar. The authorisation permits domestic manufacturing and marketing for metastatic colorectal cancer treatment.
Aurobindo Pharma's subsidiary, CuraTeQ Biologics, received marketing authorization (NOC) from Health Canada for its Bevacizumab biosimilar, Bevqolva™. This regulatory approval follows earlier UK authorization and commercial launch. The biosimilar, used to treat colorectal and lung cancers, will be available in 100 mg and 400 mg formulations, strengthening Aurobindo's global biosimilar portfolio.
Aurobindo Pharma received USFDA final approval for Dextromethorphan Polistirex Extended-Release Oral Suspension (OTC). The product, bioequivalent to Delsym, has an estimated annual market size of ₹1,283.4 Crore ($138M). Manufacturing will occur at the APL Healthcare Unit-IV facility with a planned launch in Q2FY27.
Aurobindo Pharma received final USFDA approval for Glycerol Phenylbutyrate Oral Liquid, 1.1 g/mL. The product, bioequivalent to Ravicti, targets a US$ 50.2 million (₹466.86 Crore) market. Manufacturing will occur at the company's Unit-III facility with an immediate commercial launch planned to treat urea cycle disorders.
Aurobindo Pharma received USFDA approval for Dapagliflozin and Metformin Hydrochloride ER Tablets, targeting a US$ 514 Million (₹4,780.2 Crore) market. The product, bioequivalent to AstraZeneca's Xigduo XR, will be manufactured at APL Healthcare's Unit-IV and launched immediately with 180 days of shared exclusivity.
Aurobindo Pharma received USFDA approval for Dapagliflozin Tablets (5 mg and 10 mg), addressing a US$ 10.2 billion market. The product, bioequivalent to Farxiga, will be manufactured at APL Healthcare's Unit-IV and launched immediately with 180 days of shared generic exclusivity.