Last Updated on December 22, 2024 by The Health Master
USFDA approval
Indian pharmaceutical giant Zydus Lifesciences Ltd. has secured a significant win, receiving final USFDA approval from the US Food and Drug Administration (USFDA) to market its generic Theophylline extended-release tablets, an Asthma Treatment Drug.
This medication is used for treating asthma and chronic obstructive pulmonary disease (COPD), representing a major step forward for Zydus’ expansion into the lucrative US market.
Zydus Now Set to Supply Theophylline in the US
- The USFDA approval covers Theophylline extended-release tablets in two strengths: 300 mg and 450 mg.
- These tablets will be manufactured at Zydus’ formulation manufacturing facility located within the Ahmedabad SEZ in India.
Theophylline Market Holds Promise for Zydus
- Citing IQVIA MAT March 2024 data, Zydus estimates the annual US market size for Theophylline extended-release tablets (300 mg and 450 mg) to be a promising USD 12.6 million.
This USFDA approval signifies a strategic win for Zydus Lifesciences, granting them access to a sizeable market for a well-established medication used in treating prevalent respiratory conditions.
The ability to manufacture the drug in India allows Zydus to potentially offer a cost-effective option for patients in the US, further increasing their market competitiveness.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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