Strides Pharma Gets USFDA Approval for Generic Theophylline Tablets

On September 6, 2024, Strides Pharma Science Limited announced that its subsidiary, Strides Pharma Global Pte. Limited in Singapore has received approval from the USFDA for its generic version of Theophylline Extended-Release Tablets in 300 mg and 450 mg dosages. These tablets are similar in effect to the brand name drug THEO-DUR® by Schering Corp.

The market for these tablets is about $11.5 million, with the 300 mg tablets accounting for approximately $10.8 million. The tablets will be produced at Strides’ main facility in KRS Gardens, Bangalore, India.

Financial Highlights

Strides Pharma Science Ltd reported a consolidated net profit of ₹10.44 crore for the fourth quarter ending March 2024. This is a turnaround from a net loss of ₹13.79 crore in the same quarter last year. For the fourth quarter, Strides Pharma’s total income was ₹1,070.49 crore, up from ₹1,013.49 crore a year earlier. However, total expenses increased to ₹984.21 crore from ₹972.26 crore.

For the FY March 31, 2024, the company reported a consolidated net loss of ₹94.31 crore, significantly reduced from ₹212.33 crore in the previous year. Total income for the fiscal year 2024 was ₹4,090.82 crore, compared to ₹3,778.71 crore in 2023.

About Theophylline

Theophylline Extended-Release Tablets (300 mg and 450 mg) are used to treat breathing problems like chronic chronic obstructive pulmonary disease (COPD), asthma, and bronchospasm. This medication acts as a bronchodilator, which helps ease the muscles around the airways, making breathing trouble-free. It is especially most effective in preventing and treating symptoms like wheezing, shortness of breath, and chest tightness. The extended-release form of the drug ensures a steady release, so you don’t need to take it as often, providing consistent relief from symptoms.

About Strides Pharma

Strides Pharma is a global pharmaceutical company based in Bengaluru, India. The company operates mainly in regulated markets and follows an “in Africa for Africa” strategy, along with an institutional business serving donor-funded markets. Strides has manufacturing facilities in India (Chennai, Puducherry, and 2 sites in Bengaluru), Italy (Milan), Kenya (Nairobi), and the United States (New York).

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