Kemwell’s Bangalore Facility Passes EMA Renewal AuditBy
Kemwell Biopharma, a contract development and manufacturing servicesprovider, reports that the Federal Agency for Medicines and Health Products, Belgium and the Medical Products Agency, Sweden have successfully completed a cGMP joint audit of its oral solids manufacturing facility in Bangalore, India and have provided the Certificate of GMP Compliance of a Manufacturer, valid for three years. The certificate is accepted by all health authorities in the European Union (EU) under the EU’s centralized marketing authorization procedure and by authorities of several other countries that recognize EU certification. The audit was performed as part of the European Medicines Agency’s evaluation of the marketing authorization application for a new chemical entity product for a top ten global pharmaceutical company and as a scheduled renewal audit.
Kemwell's oral solids facility has a capacity to supply over 4 billion tablets and capsules annually and is currently shipping products to many global markets including Europe, the US, Canada, UK, and Australia