Last Updated : Thursday, January 16, 2020 12:07:41

STRIDES PHARMA gets USFDA nod to market nasal treatment drug

BANGALORE | MUMBAI | RAJKOT – In a regulatory update as submitted to the Indian Stock Exchanges, Bangalore headquartered Strides Pharma Science Ltd said of having USFDA (US Food and Drugs Administration) nod to market nasal treatment drug – Loratadine OTC Softgel Capsules in 10 mg dosage value.

The press-release titled, “Strides receives USFDA approval for Loratadine OTC Softgel Capsules”, enclosed with the regulatory filing as submitted by the company to the Indian Bourses, further read that, approval to strengthen company’s private label portfolio for the US market Product to be manufactured at the flagship facility in Bangalore.

Strides Pharma Science Ltd (Strides) today announced that  its step‐down wholly owned subsidiary, Strides Pharma Global Pte. Ltd, 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.

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

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.

According  to  IRi  data, the US  market  for  Loratadine Softgel Capsules, 10 mg (OTC) 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.

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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