Drug Approval | June 16, 2023
Ipca Laboratories gets Form 483 for API manufacturing facility at Ratlam
The company will submit its comprehensive response on these observations to the US FDA
The company will submit its comprehensive response on these observations to the US FDA
The new range of HDPE bottles is compliant with US FDA, EU regulations and Chinese DMF registration for use in dry pharmaceutical applications
Patent Term Extension is designed to restore some of the patent life lost during the regulatory review process for new drugs.
The primary endpoint is to measure the change in liver stiffness measurement performed by transient elastography from Baseline to Week 52
The EU certification will support supplies of drug products registered in Europe, from this manufacturing site
Lantern is receiving an exclusive and worldwide option to license intellectual property from Bielefeld University related to the collaboration and IP generated from the collaboration
The collaboration focuses on the development and sharing of Standard Quality and Regulatory Documentation (StaQRD), a standard guide for the electronic transfer of information
Establishes distribution center in top hub for international shipping
The development and deployment of effective vaccines can help to mitigate the impact of pandemics, and we must prioritize research efforts to achieve this objective
Sun Pharma will have exclusive rights to commercialise Nidlegy for indications of skin cancers in the territories of Europe, Australia and New Zealand. Philogen will complete pivotal clinical trials for the product in Europe
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