The patent will lock in broad protection for the company’s lead therapy CardiolRx and its novel subcutaneous candidate CRD-38
This marks Lupin’s first commercial product leveraging PrecisionSphere, a proprietary long-acting injectable (LAI) technology
The observations are procedural in nature and will be responded to within the stipulated time
The said inspection concluded with Zero Form 483 observation
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025
The NDA submission follows the successful completion of a pivotal Phase III global clinical trial
This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company
Hengrui is eligible to receive regulatory and commercial milestone payments of up to US$1.093 billion
Conducted entirely in Europe across forty sites in five countries, this rigorous study met all clinical endpoints
Sun Pharma's Halol plant gets OAI classification from US FDA inspection
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