Strides Pharma Science Limited announced today that its subsidiary has received U.S. Food and Drug Administration (FDA) approval for generic Theophylline Extended-Release Tablets in 300 mg and 450 mg strengths. The company has been granted 180 days of Competitive Generic Therapy (CGT) exclusivity for the 300 mg tablets, positioning it as the first approved applicant.
The shares of Strides Pharma Science Limited were trading at ₹1,394.90 up by ₹50.05 or 3.72 per cent on the NSE at 11 am on Friday.
The medication, used to treat chronic asthma and other lung diseases, is bioequivalent to Schering Corp’s THEO-DUR. With a combined market size of approximately $11.5 million, the 300 mg dosage accounts for $10.8 million of that total, according to IQVIA data.
Strides plans to manufacture the tablets at its Bangalore facility in India. This approval strengthens the company’s portfolio in the regulated U.S. market, where it focuses on “difficult to manufacture” products.
