Strides Arcolab announced that its oral dosage forms manufacturing site (KRS Gardens) in Bangalore was recently inspected by the US FDA as part of GMP compliance audit and the facility continues to be approved with “Zero Inspectional Observation” reported in FDA 483.
The last US FDA inspection and approval for this facility was in the year 2008.
The KRS Gardens facility in Bangalore manufactures oral dosage forms such as tablets and capsules(both hard gelatine). The manufacturing plant supports important current and future submissions for the US market.
Manish Gupta, CEO, Pharma of Strides said, “This continued approval of the site with Zero obseravtion in FDA 483 augurs very well for the Pharma division of the company in this challenging regulatory and business environment.”
Strides Arcolab is a global pharmaceutical company that develops and manufactures a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectables.