ALFA Filings
Every announcement, straight from the exchange
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6 announcements with these filters
Biocon received marketing approval from Japan's MHLW for its Pegfilgrastim biosimilar. This approval enhances Biocon's biosimilar portfolio and market access in Japan.
Biocon received Health Canada approval for its Yesintek (ustekinumab) Autoinjector Pen. This new product format expands the company's immunology portfolio in Canada.
Biocon received EMA approval for a new insulin fill finish line in Malaysia. Supplies to the European market are expected to commence from Q2FY27.
Biocon Pharma received Health Canada approval for Micafungin for Injection, USP. This milestone strengthens the company's integrated biosimilars and generics portfolio in Canada.
Biocon Limited received Health Canada approval for its biosimilars Bosaya and Vevzuo, marking its entry into the Canadian denosumab market. The approval targets osteoporosis and cancer-related bone conditions, potentially benefiting over 2 million patients. This milestone strengthens Biocon's global biosimilars portfolio across immunology and oncology.
Biocon Pharma, a subsidiary of Biocon Limited, received U.S. FDA approval for Dapagliflozin Tablets (5 mg and 10 mg) for treating type 2 diabetes. The product will be manufactured at Biocon's FDA-approved facilities. This approval strengthens Biocon's global diabetes portfolio, covering oral solids, biosimilar insulins, and GLP-1 peptides.