Date: 17-Jan-2020

Strides Pharma gets US FDA approval for Loratadine Softgel capsule

Strides Pharma Science has announced that its step-down wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for Loratadine Softgel capsule 10 mg over-the-counter (OTC) drug from the United States Food and Drug Administration (USFDA). Loratadine Softgel capsule is an antihistamine that treats symptoms such as itching, runny nose, watery eyes and sneezing from "hay fever" and other allergies. The product is a generic version of Claritin Liqui-Gels Capsule, 10 mg, of Bayer HealthCare LLC. Loratadine Softgel Capsule 10 mg (OTC) is part of Strides niche and small volume product portfolio with limited competition in the US private label market. According to IRI data, the US market for Loratadine Softgel capsule, 10 mg (OTC) is approximately US$ 50 million with only one other generic approval. The product will be manufactured at the company's oral dosage facility at Bangalore. Strides is focusing on building a private label business in the US by leveraging its portfolio of products across soft gels, tablets, capsules and other proprietary formats