Strides Gets Continued US FDA Approval Status For Its Oral Dosage Facility

Strides Gets Continued US FDA Approval Status For Its Oral Dosage Facility

September 21st, 2011 // 4:45 pm @

Strides Arcolab said US FDA recently inspected its Oral Dosage Forms manufacturing facility in KRS Gardens in Bengaluru, as part of GMP compliance audit, and the facility continued 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 Bengaluru manufactures oral dosage forms such as tablets and capsules (both hard gelatine and soft gelatine. The manufacturing plant supports important current and future submissions for the US market.

CEO-Pharma Manish Gupta said, “This continued approval of the site with Zero observation in FDA 483 augurs very well for the pharma division of the company in this challenging regulatory and business environment.”


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