Drug Approval | October 19, 2024
Granules India receives ANDA approval for Bupropion Hydrochloride ER Tablets
Granules now has a total of 67 ANDA approvals from the USFDA
Granules now has a total of 67 ANDA approvals from the USFDA
VYALEV is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson's disease
Enhertu demonstrated clinically meaningful efficacy in previously treated patients
He will join in place of Anil Arora, current President- Formulations Operations who will be superannuating in November, 2024
India has been declared ‘functional’ against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI
Strokes are affecting approximately 1.8 million people annually
The partnership marks a pivotal step towards developing new therapies for combating Sickle Cell Disease
The GMP certificate will allow the manufacturing site in Hervás, Cáceres to manufacture active ingredients for the pharmaceutical industry that is based on medicinal plants
HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis
Under the licensing agreement, Alkem will carry out the clinical development of “SON-080” in India with support from Sonnet and enable global and India regulatory filings
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