Sun Pharmaceutical Announces USFDA Approval to Market Generic Tessalon

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted approval for the Abbreviated New Drug Application (ANDA) to market a generic version of Forest Lab’s Tessalon®, benzonatate capsules.

Benzonatate USP capsules are therapeutically equivalent to Forest Lab’s Tessalon®, and are available in two strengths: capsules containing 100 mg and 200 mg benzonatate USP. Benzonatate has annual sales of approximately USD 40 million in the US.

Benzonatate is an antitussive, used to relieve cough due to the common cold, bronchitis, pneumonia, or other lung infections. This product will reach market shortly. Tessalon® is a registered trademark of Forest Laboratories, Inc.

About Sun Pharmaceutical Industries Ltd.

Established in 1983, listed since 1994 and headquartered in India, Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) is an international, integrated, speciality pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world. In India, the company is a leader in niche therapy areas of psychiatry, neurology, cardiology, diabetology, gastroenterology, and orthopedics. The company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage forms. More information about the company can be found at

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