Drug Approval | October 27, 2022
USFDA Issues a CRL for the Biologics License Application for Insulin Aspart
The CRL did not identify any outstanding scientific issues with the product.
The CRL did not identify any outstanding scientific issues with the product.
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
Submission based on QuANTUM-First results showing quizartinib plus chemotherapy significantly improved overall survival compared to chemotherapy alone
None of the observations are related to data integrity and Alembic Pharmaceuticals management believes that they are addressable
Yoshindo gets exclusive commercialization rights in Japan for bUstekinumab and bDenosumab developed and manufactured by Biocon Biologics
The need for hot-melt extrusion (HME) polymers is expected to grow as the pharma industry moves to implement more continuous and sustainable processes.
The certification will open new avenues for our flagship brand “Dr Trust”, enabling them to export these devices to many more countries
The inspection of the facility was conducted from August 16-19, 2022.
Department and Industry Associations to organize 3 days National Level Expo on Indian Medical Devices Sector at Pragati Maidan, New Delhi between 9-11 Dec 2022, first of its kind expo in India
The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility
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