Zydus Lifesciences Ltd announced on Wednesday that it has received approval from the United States Food and Drug Administration (USFDA) for Theophylline extended-release tablets.
These tablets are used to treat asthma and chronic obstructive pulmonary disease (COPD).
The approval covers Theophylline Extended-Release Tablets in dosages of 300 mg and 450 mg. This means that Zydus Lifesciences can now manufacture and market these tablets in the United States. The company shared this news in a filing to the stock exchanges.
Zydus Lifesciences stated that the Theophylline extended-release tablets will be produced at the Group’s formulation manufacturing facility in Ahmedabad SEZ, Gujarat. This facility is equipped to handle large-scale production, ensuring a steady supply to meet market demands.
Theophylline extended-release tablets are important in managing respiratory conditions like asthma and COPD. These tablets help patients breathe easier by relaxing the muscles in the lungs and chest, making them a vital treatment option for those suffering from these conditions.
According to IQVIA MAT data for March 2024, the market for Theophylline Extended-Release Tablets, 300 mg and 450 mg, in the United States had annual sales of $12.6 million.
This indicates a strong demand for the medication, which Zydus Lifesciences is now well-positioned to fulfill.
