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Business EconomyPosted at: Jan 16 2020 1:03PM


Strides gets USFDA nod for Loratadine OTC Softgel Capsules

Mumbai, Jan 16 (UNI) Pharma Major Strides Pharma Science Limited on Thursday said 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 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. Loratadine Softgel Capsules, 10 mg (OTC) is part of Strides niche and small volume product portfolio with limited competition in the US private label market., company said in a filing with BSE.
According to IRI data, the US market for Loratadine Softgel Capsules, 10 mg (OTC) is approximately USD 50 Mn with only one other generic approval. The product will be manufactured at the company's Oral dosage facility at Bangalore.
The company has 102 cumulative ANDA filings with USFDA, of which 68 ANDAs have been approved and 34 are pending approval.
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Tags: #Strides gets USFDA nod for Loratadine OTC Softgel Capsules
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