Sun Pharma gets USFDA tentative approval for generic Gemzar ® injection
2008-03-05 · Sun Pharmaceutical Industries, Inc. · original sunpharma.com ↗
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 gets USFDA tentative approval for generic Gemzar® injection Mumbai, March 5, 2008: Sun Pharmaceutical Industries Ltd. announced that USFDA has granted tentative approval for the Company’s Abbreviated New Drug Application (ANDA) for its generic version of Eli Lilly and Co’s Gemzar®, gemcitabine injection. These generic gemcitabine injections are therapeutic equivalents of Eli Lilly and Co’s Gemzar® injections available in two strengths: 200 mg and 1 g single use vi al. These strengths of gemcitabine injections have annual sales of approximately USD 680 million in the US. Gemcitabine is an anticancer, used singly or in combination with other anticancer agents. Gemzar® is a registered trademark of Eli Lilly and Co. About Sun Pharma Established in 1983, listed since 1994 and headquartered in In dia, Sun Pharma (Reuters: SU N.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) is an inte rnational, integrated, speciality pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as brande d 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 form s. 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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