Strides Pharma Secures USFDA Approval for Generic Theophylline Extended-Release Tablets
核心洞察
Strides Pharma Global, a subsidiary of Strides Pharma Science (搜索), has received USFDA (搜索) approval for Theophylline Extended-Release Tablets, 300 mg and 450 mg, a generic version of Schering Corp (搜索)'s THEO-DUR.
These tablets are indicated for managing symptoms and reversible airflow obstruction linked to chronic asthma (搜索) and other chronic lung diseases like emphysema (搜索) and chronic bronchitis (搜索).
The combined market for Theophylline Extended-Release Tablets, 300 mg and 450 mg, is approximately $11.5 million, with the 300 mg dosage accounting for $10.8 million.
Strides Pharma Science (搜索) announced that its step-down wholly owned subsidiary, Strides Pharma Global, Singapore, has received approval from the United States Food and Drug Administration (USFDA (搜索)) 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 (搜索)’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 (搜索), emphysema (搜索), and chronic bronchitis (搜索). 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.