Drug Approval | August 06, 2023
Briefs: Dr. Reddy's Laboratories and Aurobindo Pharma
The inspection closed with zero observations and a classification of No Action Indicated
The inspection closed with zero observations and a classification of No Action Indicated
Shivalik Rasayan Limited has issued LOA to Medicamen Biotech to use its DMF grade Bortezomib API for formulation of Bortezomib injection 3.5mg/ vial
The inspection closed with the facility receiving an inspection classification of NAI
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
The US FDA in its communication mentioned it may withhold approval of any pending applications or supplements in which this facility is listed.
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.
Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP)
Government of India has granted a patent for invention entitled "An improved safe process for the preparation of Sartan drugs of Formula I".
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