Marksans Pharma Secures USFDA Approval for Generic Version of Clarinex

Marksans Pharma Limited has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Loratadine Tablets USP 10 mg. These tablets are intended for over-the-counter (OTC) use to treat allergic rhinitis caused by pollen and upper respiratory tract allergies. Loratadine, an antihistamine, relieves symptoms such as itching, runny nose, watery eyes, and sneezing caused by "hay fever" and other allergies.

This product is the generic version of the Clarinex tablet manufactured by Bayer Healthcare in the same strength. The approval enables Marksans Pharma to expand its presence in the allergy medication market in the United States.

Marksans Pharma, headquartered in Mumbai, India, specializes in the research, manufacturing, and marketing of generic pharmaceutical formulations across global markets. The company operates manufacturing facilities in India, the United States, and the United Kingdom, which leading regulatory agencies, including the USFDA, UKMHRA, and Australian TGA approve.

The company boasts a robust product portfolio encompassing several major therapeutic areas such as cardiovascular (CVS), central nervous system (CNS), anti-diabetics, pain management, upper respiratory, and gastroenterology. Marksans Pharma markets its products in diverse international markets, affirming its global reach and commitment to providing high-quality, affordable pharmaceuticals.