Strides Pharma Science Ltd Share Price – NSE  /  BSE

Pharmaceuticals, Small Cap

Strides Pharma Science today announced that its step‐ down wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval for Fluoxetine Tabs 10 mg and 20 mg, from the United States Food & Drug Administration (USFDA).  

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Prozac®   Tablets of Eli Lilly.   Fluoxetine tablets has a market size of ~US$ 23.9 Mn as per IMS.

This approval further strengthens the Company's presence in the Fluoxetine portfolio, complementing the existing approval of Fluoxetine  capsules, which has a marketsize of US$106 Mn. The Fluoxetine tablets will be manufactured at the company's facility in Puducherry.

The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with USFDA, of which 245 ANDAs have been approved. The company has set a target to launch ~ 60 new products over three years in the US.

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The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD) Prozac Tablets of Eli Lilly.

Fluoxetine is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is used for the treatment of major depressive disorder (MDD), obsessive–compulsive disorder (OCD), bulimia nervosa, panic disorder, with or without agoraphobia.Fluoxetine Tablets have a market size of approximately $23.9 million, as per IMS.

This approval further strengthens the company's presence in the Fluoxetine portfolio, complementing the existing approval of Fluoxetine capsules, which has a marketsize of $106 million. The Fluoxetine Tablets will be manufactured at the company’s facility in Puducherry.

The company has 260 cumulative ANDA filings (including the recently acquired portfolio from Endo at Chestnut Ridge) with US FDA, of which 245 ANDAs have been approved. The company has set a target to launch nearly 60 new products over three years in the US.

Strides Pharma Science is engaged in develops and manufactures a wide range of IP-led niche pharmaceutical products.

The firm reported consolidated net profit of Rs 49.67 crore in Q3 FY24 as against a net loss of Rs 80.03 crore posted in Q3 FY23. The company recorded quarterly sales of Rs 1,038.9 crore in Q3 FY24, registering a growth of 19.60% from Rs 868.6 crore in Q3 FY23.

The scrip rose 0.09% to currently trade at Rs 846.35 on the BSE.

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Strides Alathur is a wholly owned subsidiary of Strides Pharma Science. The inspection closed with two observations.

The drug maker informed that it will respond to these observations comprehensively to US FDA within the stipulated time.

Strides Pharma Science is engaged in develops and manufactures a wide range of IP-led niche pharmaceutical products.

The firm reported consolidated net profit of Rs 49.67 crore in Q3 FY24 as against a net loss of Rs 80.03 crore posted in Q3 FY23. The company recorded quarterly sales of Rs 1,038.9 crore in Q3 FY24, registering a growth of 19.60% from Rs 868.6 crore in Q3 FY23.

The scrip rose 0.40% to trade at Rs 849.55 on the BSE.

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Strides Pharma Science announced that a routine current Good Manufacturing Practices (cGMP) inspection was conducted by the United States Food and Drug Administration (USFDA) at the Formulations Facility of Strides Alathur, a wholly owned subsidiary of the Company, at Alathur, Chennai during the week of 01 April 2024 to 05 April 2024. The inspection closed with two observations.

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