Glenmark Pharma gets observations from USFDA for its Goa and Monroe facilities
A total of five observations for Goa and 17 for Monroe
A total of five observations for Goa and 17 for Monroe
Myovant to receive an upfront payment of US $50 million, is eligible to receive commercial launch, sales-based and other milestones totaling up to US $90.5 million
The company is preparing the response to the observations, which will be submitted to the USFDA within 15 business days
Digital PCR format allows for rapid turnaround time to facilitate fast and accurate post-transplant treatment decisions
This newly designed small-format detector is made up of caesium iodide technology and is extremely high in resolution, capable of capturing the fine detail of smaller anatomical structures present in paediatric patients
Ranked 25th with an impressive growth rate of 29% among Indian pharma companies in FY 2021-22
Demand for pharmacies contribute to 52% of the total searches, vaccination centres 30%
The inspection report contains no 'critical' observations and only one of the deficiencies is categorized as 'major' which is being addressed expeditiously in consultation with the regulatory agency
The inspection was triggered by Shilpa's submission of applications for four ANDA's to seek approval to use this site as an alternate testing laboratory
Blood test for early detection of Alzheimer's Disease (AD) risk will lead to better patient care, physicians say; US. adults call for earlier evaluation and more education
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