Industry News

Zydus Lifesciences has received the Establishment Inspection Report from the United States Food and Drug Administration for its Active Pharmaceutical Ingredient manufacturing facility located at Dabhasa, near Vadodara, Gujarat.

Zydus Lifesciences Ltd. announced its entry into the global biologics contract development and manufacturing organization

Ichnos Glenmark Innovation (IGI), a global, fully integrated clinical- stage biotechnology company focused on developing multispecificsTM in oncology, today presented promising full dose-escalation results from its Phase 1 TRIgnite-1 study of ISB 2001

Biocon Pharma Limited, has received approval for its Liraglutide drug product (6 mg/ml solution for injection in pre-filled pen and cartridge), from the Drugs Controller General of India, CDSCO (Central Drugs Standard Control Organisation).

U.S. Food and Drug Administration approval of a New Drug Application for KHINDIVI hydrocortisone Oral Solution as a replacement therapy in pediatric patients five years of age and older with adrenocortical insufficiency.

Amneal Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has approved Brekiya dihydroergotamine mesylate injection, the first and only dihydroergotamine autoinjector for the acute treatment of migraine with or without aura and the acute treatment of cluster headaches in adults.

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration for Glatiramer Acetate Injection, 20 mg/mL and 40 mg/mL, single-dose prefilled syringes.

Senores Pharmaceuticals Limited through its wholly-owned subsidiary Senores Pharmaceuticals, Inc., USA, has signed agreement today to acquire the USFDA-approved Abbreviated New Drug Application for Topiramate HCl 25, 50, 100 and 200 mg tablets Topiramate from Wockhardt Limited.

Biocon Biologics Ltd , a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced the Company has secured multiple market access agreements for Yesintek™, its biosimilar to Stelara®. The market access agreements from numerous plans represent over 100+ million lives in the United States.