Strides Pharma Makes Strategic Move with USFDA Approval for Fluoxetine Tablets

Strides Pharma Science Limited (Strides), a leading pharmaceutical company, has taken a significant step towards expanding its presence in the lucrative US market. On April 9, 2024, the company announced that its step‐down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Fluoxetine Tabs 10 mg and 20 mg from the United States Food & Drug Administration (USFDA).

Expanding Fluoxetine Portfolio

Fluoxetine is a well-established selective serotonin reuptake inhibitor (SSRI) medication commonly used to treat depression, anxiety disorders, and other conditions. Strides’ newly approved Fluoxetine tablets are bioequivalent and therapeutically equivalent to the reference listed drug (RLD) Prozac® Tablets from Eli Lilly.

Targeting a Lucrative Market

According to IMS, the US market for Fluoxetine tablets holds significant potential, valued at approximately US$23.9 million. This approval complements Strides’ existing USFDA approval for Fluoxetine capsules, which have a market size of US$106 million. By offering both tablets and capsules, Strides caters to a wider range of patient preferences and dosing needs, solidifying its position within the entire fluoxetine product category.

Manufacturing and Development Strategy

Strides plan to manufacture the newly approved Fluoxetine tablets at their facility in Puducherry, India. This leverages their existing infrastructure and manufacturing expertise to ensure a consistent and reliable supply for the US market. Furthermore, Strides boasts a robust pipeline of generic drug development efforts. With a cumulative total of 260 ANDA (Abbreviated New Drug Application) filings with the USFDA, including those acquired from Endo at Chestnut Ridge, they demonstrate a strong commitment to expanding their US product portfolio.

Looking Ahead

The USFDA approval for Fluoxetine tablets signifies a strategic move by Strides Pharma. It not only broadens their product portfolio but also positions them to capture a significant share of the US fluoxetine market as they gear up for the launch of these new tablets and pursue their goal of introducing 60 new products in the US over the next three years.

About Strides Pharma Science Limited

Strides Pharma Science Limited is a global pharmaceutical company headquartered in Bengaluru, India, which mainly operates in regulated markets. Its global manufacturing sites are located in India (Chennai, Puducherry, and two locations in Bengaluru), Italy (Milan), Kenya (Nairobi), and the United States (New York).

On April 09, 2024, the Strides Pharma share price opened at ₹850.15 and touched the day high of ₹860.00 at 09:35 AM.

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