Briefs: NATCO Pharma, Strides Pharma and Aurobindo Pharma
Strides Pharma Science Limited to acquire 100% in Strides Pharma Services Pvt Ltd.
Strides Pharma Science Limited to acquire 100% in Strides Pharma Services Pvt Ltd.
The inspection classification was determined by the agency as Voluntary Action Indicated
The inspection closed with zero observations and a classification of No Action Indicated
The inspection closed with zero observations
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
This is the second US FDA GMP inspection of this facility within one year
The USFDA had classified Strides Puducherry facility as OAI in May 2019 followed by issuing a warning letter to this site in July 2019.
Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.
Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP)
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