Strides Pharma subsidiary gets USFDA approval for Loratadine Softgels

Strides Pharma Science Limited has announced that its step‐down wholly-owned subsidiary, Strides Pharma Global Pte Limited (Singapore) has received approval for Loratadine Softgel Capsules, 10 mg (OTC) from the United States Food & Drug Administration (USFDA). The product is a generic version of Claritin Liqui‐Gels Capsules, 10 mg, of Bayer HealthCare LLC.

Strides is focussing on building a private label business in US by leveraging its portfolio of products across soft gels, tablets, capsules and other proprietary formats. Loratadine Softgel Capsules, 10 mg, is part of Strides niche and small volume product portfolio with a limited competition in US private label market. According to IRi data, the US market for Loratadine Softgel Capsules, 10 mg, is approximately US$ 50 mn with only one other generic approval. The product will be manufactured at the company’s oral dosage facility at Bangalore.

Loratadine Softgel Capsules is an antihistamine that treats symptoms such as itching, runny nose, watery eyes, and sneezing from ‘hay fever’ and other allergies.

The company has 102 cumulative Abbreviated New Drug Application (ANDA) filings with USFDA of which 68 ANDAs have been approved and 34 are pending approval.

On Wednesday, the stock of Strides Pharma had closed at Rs 389.60. On Thursday, it opened at Rs 390.45 and went up to Rs 391.20 during the early morning session.