Sun Pharma Announces USFDA Approval for Generic Diltiazem ER®

MUMBAI, India--()--Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of once-a-day Tiazac® extended release capsules.

These generic Tiazac capsules contain Diltiazem Hydrochloride Extended-release USP, 120 mg, 180 mg, 240 mg,300 mg and 360 mg, and are therapeutically equivalent to Biovail Corporation’s Tiazac ® extended release capsules.

Generic Tiazac® Capsules are indicated for the treatment of hypertension, used alone or in combination with other antihypertensive medications. Generic Tiazac® Capsules are also used in the treatment of Chronic stable angina.

Extended release Diltaizem Hydrochloride USP capsules have annual sales of approximately $ 46 million in the US.

® Registered trademark of Biovail Corporation

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, orthopedics and ophthalmology. 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 www.sunpharma.com.

Contacts

Sun Pharmaceutical Industries Ltd.
Uday Baldota
Tel: +91 22 6645 5645, Xtn 605
Tel Direct: +91 22 66455605
Mobile: +91 98670 10529
E mail: uday.baldota@sunpharma.com
or
Mira Desai
Tel: +91 22 6645 5645, Xtn 606
Tel Direct: +91 22 66455606
Mobile: +91 98219 23797
E mail: mira.desai@sunpharma.com

Release Summary

Sun Pharma Announces USFDA Approval for Generic Diltiazem ER®

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Contacts

Sun Pharmaceutical Industries Ltd.
Uday Baldota
Tel: +91 22 6645 5645, Xtn 605
Tel Direct: +91 22 66455605
Mobile: +91 98670 10529
E mail: uday.baldota@sunpharma.com
or
Mira Desai
Tel: +91 22 6645 5645, Xtn 606
Tel Direct: +91 22 66455606
Mobile: +91 98219 23797
E mail: mira.desai@sunpharma.com