Sun Pharma announces USFDA approval for generic Ultram® ER tablets
2011-12-09 · Sun Pharmaceutical Industries, Inc. · original sunpharma.com ↗
Sun Pharmaceutical Industries Ltd. 17/B, Mahal Industrial Estate, Mahakali Caves Road, Andheri (East), Mumbai 400 093 India Tel.: (91-22) 6645 5645 Fax.: (91-22) 6645 5685 Registered Office : SPARC, Tandalja, Vadodara – 390 020. India Corporate Office : Acme Plaza, Andheri – Kurla Road, Andheri (East), Mumbai – 400 059. India FOR IMMEDIATE RELEASE Sun Pharma announces USFDA approval for generic Ultram® ER Tablets Mumbai, December 9, 2011: Sun Pharmaceutical In dustries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) announced that US FDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Ultram ® ER, Tramadol hydrochloride extended release tablets. These generic Tramadol hydrochloride extended release tablets, 100 mg, 200 mg and 300 mg. are therapeutically equivalent to Ultram® ER tablets of Valeant. These tramadol HCL ER tablets have annual sales of approximately USD 125 million in US. Tramadol HCL ER tablets are indicated for management of moderate to moderately severe chronic pain in adults who need around-the-clock treatment of their pain for an extended period of time. Ultram ®ER is a registered trademark of Valeant Intl. 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 la rge 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 Uday Baldota Mira Desai Tel +91 22 6645 5645, Xtn 605 Tel +91 22 6645 5645, Xtn 606 Tel Direct +91 22 66455605 Tel Direct +91 22 66455606 Mobile +91 98670 10529 Mobile +91 98219 23797 E mail [email protected] E mail [email protected]
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