The acquisition aligns with Granules' vision to enter the rapidly expanding peptide-based anti-diabetic and anti-obesity market
Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder in adults and pediatric patients aged six years and older
The company said it voluntarily paused production at the Gagillapur plant in September 2024 for risk assessment on account of the USFDA observations
Granules has undertaken a proactive, voluntary and comprehensive remediation plan to address the six form 483 observations raised by the USFDA
In the near term, the company targets a 42% reduction in absolute Scope 1 and 2 emissions and Scope 3 emissions by FY2030
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
Revenue share from the North America increased to 79% in Q2 FY25 as compared to 67% in Q2 FY24
Granules now has a total of 67 ANDA approvals from the USFDA
He will join in place of Anil Arora, current President- Formulations Operations who will be superannuating in November, 2024
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