Drug Approval | January 24, 2023
USFDA inspection at Indoco Remedies's Solid Oral Formulation Facility at Goa
USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.
USFDA issued issued Form 483 with nine observations, which will be addressed within stipulated time.
It is administered as a single infusion 30 minutes prior to the start of each chemotherapy cycle that helps prevent, both, acute and delayed phases of CINV
The company is adding new capabilities of Combi-line for Microsphere, additional Bag line and lyos for the Penem block in Pashamylaram facility in Hyderabad and will be earmarking capital for further building on its Biosimilar CDMO facility
The National Institute of Pharmacy and Nutrition, Hungary has issued 'Certificate of GMP Compliance of Manufacturer' for IOL Chemicals and Pharmaceuticals Limited's products.
Connectivity and harmonisation were both key driving factors behind our decision to choose the CARA Life Sciences Platform to consolidate our processes
The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations
The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines.
Palbociclib has a unique mechanism of action which helps in delaying disease progression when co-administered with hormonal therapies
A committee of two Joint Drugs Controllers has been constituted at CDSCO to monitor the process of inspection, reporting, and subsequent action to ensure compliance to the Drugs & Cosmetics Act, 1940
None of the observations are related to data integrity and management believes that they are addressable
Subscribe To Our Newsletter & Stay Updated
