Kemwell Biopharma Pvt Ltd said its oral solids manufacturing facility located in Bangalore has successfully completed its ANIVSA inspection by the Brazilian regulatory body.
Kemwell, a global bio/pharmaceutical contract development and manufacturing company, has been regularly shipping products to Europe, Australia, Canada and USA from this facility.
On completion of the inspection, the ANVISA inspector concluded that the facility systems and practices comply with ANVISA requirements and the audit was completed with no open points, said Kemwell.
“This is our second successful audit within a span of two months. Our facility was re-audited by the USFDA this March with no observations. Our team has been consistently committed in developing and executing strong quality systems. Successful inspections like these validate our on-going efforts. In our 30-year history, we have placed foremost importance on providing the highest quality standards,” said Anurag Bagaria, Chairman and Managing Director of Kemwell.
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 Biopharma is a 100% CDMO that provides customized product development and cGMP compliant manufacturing solutions to pharmaceutical and biopharmaceutical organizations worldwide. With integrated facilities in India, US and Sweden, Kemwell delivers a comprehensive portfolio of services for sterile and non-sterile products from preformulation to commercial supply.
Kemwell facilities are approved by ANVISA, USFDA, EMA, HC and PMDA. Founded in 1980, it has 10 facilities worldwide and supplies to 80 countries.
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