Thursday, March 13, 2014

USFDA import alert for Sun Pharma's Karkhadi unit in Gujarat

USFDA import alert for Sun Pharma's Karkhadi unit in Gujarat
Sun Pharmaceutical Industries Ltd (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) announced an import alert from the US FDA for its cephalosporin facility located at Karkhadi, Gujarat in India. This import alert was issued by the US FDA as a follow up to the last inspection of the facility, during which some non-compliance of current Good Manufacturing Practice (cGMP) regulations were identified.
The company remains fully committed to compliance and has already initiated several corrective steps to address the observations made by the US FDA.  The contribution of this facility to Sun Pharma’s consolidated revenues is negligible. Sun Pharma maintains its FY2013-14 consolidated sales growth guidance.

About Sun Pharma
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 specialty pharmaceutical company with over 70% sales from global markets. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in US, India and several other markets across the world. For the year ending March 2013, overall revenues were at US$2.1 billion, of which US contributed US$1.1 billion. In India, the company is a leader in niche therapy areas of psychiatry, neurology, cardiology, nephrology, gastroenterology, orthopedics and ophthalmology. The company has strong skills in product development, process chemistry, and manufacturing of complex dosage forms. More information about the company can be found at www.sunpharma.com.