Strides Pharma receives US FDA Nod for theophylline ER tablets

The FDA has approved Strides Pharma Global, Singapore's generic theophylline extended-release tablets, 300 mg and 450 mg.The product is identical in bioavailability and therapeutic effects to the Reference Listed Drug (RLD), THEO-DUR, from Schering Corp. theophylline extended-release tablets are used for addressing symptoms and reversible airflow obstruction linked to chronic asthma and other chronic lung diseases such as emphysema and chronic bronchitis.

According to IQVIA, the total market size for Theophylline extended-release tablets of 300 mg and 450 mg is US$ 11.5 mn, with the 300 mg dosage accounting for US$ 10.8 mn. The company will produce theophylline extended-release tablets, 300 mg and 450 mg, at their main facility in KRS Gardens, Bengaluru.

Theophylline extended-release tablets, in doses of 300 mg and 450 mg, are utilized for treating respiratory illnesses such as chronic asthma, chronic obstructive pulmonary disease (COPD), and bronchospasm. The drug acts as a bronchodilator, helping to relax the muscles surrounding the bronchial tubes for improved breathing. It is especially beneficial in preventing and managing symptoms like wheezing, difficulty breathing, and chest constriction. The prolonged drug release of the extended-release version reduces dosing frequency and gives consistent symptom relief over time.

Strides primarily focuses on regulated markets and follows an "in Africa for Africa" approach, with an institutional business that caters to markets funded by donors. The Company has manufacturing facilities worldwide, with plants in India including Chennai, Puducherry, and two in Bengaluru, as well as locations in Italy (Milan), Kenya (Nairobi), and the United States (New York).