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Kemwell Biopharma has announced they successfully completed a current good manufacturing practice (cGMP) joint audit of its oral solids manufacturing facility in Bangalore, India.
The audit was conducted by the Federal Agency for Medicines and Health Products and the Medical Products Agency (MPA).
Kemwell Biopharma was provided with a certificate of GMP compliance, valid for three years.
The certificate is accepted by health authorities in the EU under its centralised marketing authorisation procedure.
The audit was part of the European Medicines Agency’s (EMA) evaluation of the marketing authorisation application for an NCE product for a top ten global pharmaceutical company, and as a scheduled renewal audit.
Kemwell’s oral solids facility has the capacity to supply more than four billion tablets and capsules annually.
The company currently ships products to global markets including Europe, US, Canada, UK, Australia and South Africa.
Kemwell chairman Anurag Bagaria said: "Kemwell understands the need to maintain high quality standards and to deliver products to customers on time.
"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."
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