Mumbai-based Marksans Pharma Limited announced today that it has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Loratadine Tablets USP 10 mg.
The shares of Marksans Pharma Limited were trading at ₹ 315.15 up by ₹6 or 1.94 on the NSE today at 12.23 pm.
The approved drug is a generic version of Bayer Healthcare’s Claritin tablets and will be available for over-the-counter (OTC) use. Loratadine is an antihistamine used to treat allergic rhinitis symptoms, including itching, runny nose, watery eyes, and sneezing caused by seasonal allergies and upper respiratory tract conditions.
The approval adds to Marksans Pharma’s growing portfolio of generic pharmaceutical formulations. The company operates manufacturing facilities across India, USA, and UK, which are approved by major regulatory agencies including USFDA, UK MHRA, and Australian TGA.
Marksans Pharma’s current product range covers major therapeutic segments including cardiovascular, central nervous system, anti-diabetic, pain management, upper respiratory, and gastroenterological treatments. The company focuses on research, manufacturing, and marketing of generic pharmaceutical formulations in global markets.