An oral solid dose manufacturing plant in Bangalore, India operated by CMO Kemwell Biopharma has passed a customer-prompted audit by European regulators and had its cGMP status renewed for the next three years.
The India-headquartered contractor announced it had passed the audit today, explaining that it was performed as part of the European Medicines Agency's (EMA) evaluation of a drug being developed by an unnamed top ten global pharma company.
Karan Bagaria, Kemwell vice president of corporate development, told Outsourcing-pharma.com that the audit was conducted in February and that the Bangalore site makes “general pharmaceutical products.”
The inspection was a joint effort by inspectors from the Federal Agency for Medicines and Health Products, Belgium and the Medical Products Agency (MPA), Sweden under the European Union’s centralized marketing authorization procedure
This was reiterated by Bagaria, who explained that: “The facility is approved by US FDA and we have approval from Health Canada and TGA based on the EMA approval.”
Renewal of the Bangalore site’s cGMP status follows just a few months after Kemwell installed commercial-scale lyophilisation capacity at its neighboring biopharmaceutical drug substance production plant.
The Bangalore site produces oral solid dose drugs for more than 80 markets around the world according to Kemwell chairman and managing director, Anurag Bagaria, who said the cGMP renewal is key to the firm’s business.
“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.”