Last Updated on September 30, 2024 by The Health Master
USFDA approval
Strides Pharma Science, a leading global pharmaceutical company, has achieved a significant milestone with the USFDA approval of its generic version of Theophylline Extended-Release Tablets, 300 mg and 450 mg, by the United States Food and Drug Administration (USFDA).
This USFDA approval marks a major step forward for Strides Pharma in expanding its presence in the US market.
A Breakthrough for Respiratory Health
Theophylline Extended-Release Tablets are a vital medication used in symptoms and reversible airflow obstruction associated with chronic asthma, emphysema, and chronic bronchitis.
These conditions can significantly impact a person’s quality of life, and effective treatment options are essential.
Bioequivalence and Therapeutic Equivalence
Strides Pharma’s generic version of Theophylline Extended-Release Tablets has been determined to be bioequivalent and therapeutically equivalent to the brand-name drug, THEO-DUR.
This means that it delivers the same therapeutic effect as the original medication.
A Significant Market Opportunity
The combined market size of Theophylline Extended-Release Tablets, 300 mg and 450 mg, in the United States is estimated to be approximately $11.5 million, with the 300 mg dosage accounting for the majority of the market.
This represents a significant opportunity for Strides Pharma to capture a share of this growing market.
Manufacturing Excellence
Strides Pharma’s Theophylline Extended-Release Tablets will be manufactured at its state-of-the-art facility in KRS Gardens, Bengaluru, India.
This facility is known for its high quality standards and adherence to stringent regulatory requirements.
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Disclaimer: This content provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.
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