Drug Approval | June 24, 2023
Ipca Laboratories receives 8 observations from USFDA
The company will submit its comprehensive response on these observations to the USFDA
The company will submit its comprehensive response on these observations to the USFDA
The company will supply materials to all global regions including Asia such as China, India, Europe, and the U.S.
Sajjan India Limited is looking for expansion, both organically and through acquisitions, to achieve the planned growth
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
The company will submit its comprehensive response on these observations to the US FDA
UTD2 is the world's first oral epothilone microtubule inhibitor
The collaboration focuses on the development and sharing of Standard Quality and Regulatory Documentation (StaQRD), a standard guide for the electronic transfer of information
Pharmaceutical sales was flat and stood at Rs. 309 crore as compared to Rs. 308 crore in Q4 FY22
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.
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