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Strides Pharma Shares Hit 52-Week High on Tentative USFDA Approval

The drug will be manufactured in the company's Bengaluru facility.

Stride Pharma shares hit a 52-week high of Rs 522.75 on 15 September after its wholly owned subsidiary, Stride Pharma Global Pte. Ltd., received tentative approval from USFDA (United States Food and Drug Administration) for its Dolutegravir 50mg tablets.

The Dolutegravir 50mg tablet is a bioequivalent and therapeutically equivalent to the RDL (reference listed drug) of ViiV Healthcare Company’s Tivicay Tablets.

The drug will be manufactured in the company’s Bengaluru facility.

The conversion from tentative approval to full approval is expected upon the expiry of the constraining patents.

The company has a total of 260 ANDA (abbreviated new drug application), out of which 230+ ANDA have been approved by the USFDA.

The company is looking to launch 60 new products in the span of the next 3 years.

On 9 September, the company’s subsidiary received approval from the USFDA for Sevelamer Carbonate for Oral Suspension USP, 0.8g and 2.4g.

On 7 September, the Board of Directors of the company approved acquiring a 100% stake in Strides Pharma Services Private Limited (SPSPL).

At 1:45 pm, the shares of Strides Pharma were trading at Rs 511.40 or 9.24% above its previous close on NSE.

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