Strides Pharma Science arm gets USFDA nod for generic version of Theophylline Extended Release Tablets
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2024-09-06 07:56 GMT | Update On 2024-09-06 07:56 GMT
Bangalore: Strides Pharma Science Limited today announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for the generic version of Theophylline Extended-Release Tablets, 300 mg and 450 mg, from the United States Food & Drug Administration (USFDA).
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), THEO-DUR, of Schering Corp.
Theophylline extended-release tablets are indicated for the treatment of symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.
Theophylline Extended-Release Tablets, 300 mg and 450 mg have a combined market size of ~US$ 11.5 mn, with the 300 mg dosage contributing ~US$ 10.8 mn as per IQVIA.
The Theophylline Extended-Release Tablets, 300 mg and 450 mg will be manufactured at the company’s flagship facility in KRS Gardens in Bangalore, India.
The medication works as a bronchodilator, relaxing the muscles around the bronchial tubes to ease breathing. It is particularly helpful in preventing and treating symptoms such as wheezing, shortness of breath, and chest tightness. The extended-release formulation allows for prolonged drug release, reducing the frequency of dosing and providing consistent relief from symptoms over time.
Strides, a global pharmaceutical company headquartered in Bengaluru, India, is listed on the BSE Limited (532531) and National Stock Exchange of India Limited (STAR). The Company mainly operates in the regulated markets and has an “in Africa for Africa” strategy and an institutional business to service donor- funded markets. The Company’s global manufacturing sites are located in India (Chennai, Puducherry, and two locations in Bengaluru), Italy (Milan), Kenya (Nairobi), and the United States (New York).
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