Sun Pharma announces USFDA approval for generic Seroquel® tablets
2012-03-28 · 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 Seroquel® tablets Mumbai, March 28, 2012: 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) for generic version of Seroquel®, Quetiapine Fumarate Tablets, in multiple strengths. These generic Quetiapine Fumarate tablets, 25 mg (base), 50 mg (base), 100 mg (base), 200 mg (base), 300 mg (base) and 400 mg (base) are therapeutic equivalents of AstraZeneca LP’s Seroquel ® tablets of similar strengths. Quetiapine Fumarate tablets have annual sale of approximately $ 4.5 billion in the US. Quetiapine Fumarate tablets are indicated for the treatment of schizophrenia and acute treatment of manic episodes associated with bipolar I diso rder, both as monotherapy and as an ad junct to lithium or divalproex. It is also indicated for acute treatment of depressive episodes associated with bipolar disorder as well as maintenance treatment of bipolar I disorder as an adjunct to lithium or divalproex. Seroquel® is a registered trademark of AstraZeneca LP. About Sun Pharmaceutical Industries Ltd. Established in 1983, listed since 1994 and headquartered in Indi a, Sun Pharmaceutical Indust ries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) is an internat ional, integrated, speciality pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulat ions as branded generics as well as generics in India, US and several other markets across the world. In India, the compan y is a leader in niche therapy areas of psychiatry, neurology, cardiology, nephrology, gastroenterology , ophthalmology and orthopedics. The company has strong skills in product development, process chemistry, and manufacturing of complex A P I , a s w e l l a s d o s a g e f o r ms. 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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