Strides Pharma Science announced that its step-down wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval from the United States Food and Drug Administration (USFDA) for its generic version of Theophylline Extended-Release Tablets in 300 mg and 450 mg dosages. This approval marks a significant step in providing a cost-effective alternative for patients managing chronic respiratory conditions.
The approved product is bioequivalent and therapeutically equivalent to Schering Corp’s Reference Listed Drug (RLD), THEO-DUR. Theophylline extended-release tablets are prescribed for the symptomatic treatment and management of reversible airflow obstruction associated with chronic asthma, emphysema, and chronic bronchitis. These conditions represent a substantial burden on public health, affecting millions worldwide and requiring long-term management strategies.
Market and Manufacturing
According to IQVIA data, the combined market size for Theophylline Extended-Release Tablets, 300 mg and 450 mg, is approximately $11.5 million. The 300 mg dosage contributes the majority, accounting for around $10.8 million of the total market. This highlights the demand for this particular dosage strength in managing respiratory conditions.
The manufacturing of Theophylline Extended-Release Tablets, 300 mg and 450 mg, will take place at Strides Pharma's flagship facility located in KRS Gardens, Bengaluru, India. This facility is equipped to handle the production of a range of pharmaceutical products, ensuring quality and consistency in manufacturing processes.
