Sun Pharma subsidiary receives warning letter from USFDA
Mumbai, August 31, 2010: Sun Pharmaceutical Industries, Inc, (“SPI Inc”) a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd. (“Sun Pharma”), received a warning letter from the United States Food and Drug Administration (USFDA).
This letter was issued by the USFDA as a follow up to the last inspection of the SPI Inc manufacturing facility in Cranbury, New Jersey, US, initiated in Feb 2010 during which the USFDA had identified violations of current Good Manufacturing Practice (cGMP) regulations. SPI Inc has undertaken immediate corrective actions.
SPI Inc intends to respond promptly and timely to the USFDA within fifteen working days. SPI Inc is committed to working cooperatively and expeditiously with the USFDA to resolve the matters indicated in its letter.
Until the SPI Inc responses to the observations have been clarified and explanations provided to the satisfaction of the USFDA, the USFDA may, in the near term, withhold approval of pending new drug applications listing the facility as the manufacturer.
Sun Pharma maintains its 2010-11 consolidated sales growth guidance.
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 www.sunpharma.com.
Tel : +91 22 6645 5645, Ext 605
Tel Direct : +91 22 66455605
Mobile : +91 98670 10529
E mail: uday.baldota@sunpharma.com Mira Desai
Tel : +91 22 6645 5645, Ext 606
Tel Direct : +91 22 66455606
Mobile : +91 98219 23797
E mail : mira.desai@sunpharma.com
Posted: August 2010
