Drug Approval | December 20, 2023
Briefs: Aurobindo Pharma and Granules Pharmaceuticals
Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection
Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection
The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
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.
Subscribe To Our Newsletter & Stay Updated
