Drug Approval | November 20, 2024
Lupin receives USFDA approval for mixed salts of a single-entity amphetamine ER capsules
The product will be manufactured at Lupin’s Somerset facility in the US
The product will be manufactured at Lupin’s Somerset facility in the US
Bumetanide Injection USP (RLD Bumex) had an estimated annual sale of USD 20 million in the US
Aromatic L-amino acid decarboxylase deficiency is a rare genetic disorder that affects the production of some neurotransmitters
The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants
The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit
This product will be manufactured at Lupin’s Nagpur facility in India
The US District Court of New Jersey decided to grant a preliminary injunction delaying the launch of LEQSELVI
Fludrocortisone acetate tablets will be produced at the Group's manufacturing site at Moraiya, Ahmedabad
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
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