Kemwell Biopharma has successfully completed a cGMP joint audit by The Federal Agency for Medicines and Health Products, Belgium and the Medical Products Agency (MPA), of its oral solids manufacturing facility in Bangalore, India, receiving a certificate of GMP compliance as a manufacturer, which is valid for three years.
The audit was performed as part of the European Medicines Agency's (EMA) evaluation of the Marketing Authorization Application for a NCE for a top global pharma company and as a scheduled renewal audit.
According to Anurag Bagaria, chairman and managing director, “Kemwell understands the need to maintain high quality standards and to deliver products to our customers on-time. Through an unwavering commitment to continuous improvement, we supply products to over 80 countries worldwide with an assured level of quality and value. This positive audit underscores the high standards Kemwell upholds in contract manufacturing of products for commercial use and for products under development in compliance with rigorous international standards.”