Kemwell Biopharma, a global biopharma contract development and manufacturing company has successfully completed its second US Food and Drug Administration (FDA) inspection.
The US FDA audit was conducted for its oral solids manufacturing facility in Bengaluru for an ANDA (abbreviated new drug application ) filed for a customer.
On completion of the inspection, the US FDA inspector concluded that the facility, systems and practices complied with the US FDA requirements and no observations were reported on Form 483, stated the company.
“This success is testament to our ongoing commitment towards our quality systems by our team. We would continue to leverage our over 30-year experience in being a leading contract development and manufacturing orgnaisation (CDMO) to provide our customers with cost-effective solutions at high quality standards”, stated Anurag Bagaria, chairman and managing director, Kemwell Biopharma.
The state-of-the-art oral solids facility started cGMP production in 2008 and is designed to produce five billion tablets and capsules annually. The facility has high flexibility built-in to manage batch sizes ranging from 10kg to 1000kg. Kemwell has been regularly shipping products to Europe, Australia, Canada and USA from this facility, he added.
The 34-year old company is a 100 per cent CDMO offering customized product development and cGMP compliant manufacturing solutions to pharmaceutical and biopharmaceutical majors worldwide. These include 7 to the top 10 big pharma. Its 10 integrated facilities in India, US and Sweden, provides comprehensive portfolio of services for sterile and non-sterile products from pre-formulation to commercial supply to 80 countries. Its facilities are approved not just by US FDA but also EMA, Health Canada and Pharmaceutical and Medical Devices Agency (PMDA), Japan.