Lupin launches Bumetanide Injection USP in US

Bumetanide Injection USP (RLD Bumex) had an estimated annual sale of USD 20 million in the US

USFDA approves first gene therapy for treatment of aromatic L-amino acid decarboxylase deficiency

Aromatic L-amino acid decarboxylase deficiency is a rare genetic disorder that affects the production of some neurotransmitters

Merck receives positive EU CHMP opinion for pembrolizumab plus chemotherapy as first-line treatment for unresectable non-epithelioid MPM

Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial

Shilpa Medicare Q2 FY25 consolidated PAT up 1,008% at Rs. 18 Cr

EMA grants GMP Certificate of compliance to CuraTeQ biosimilars’ Hyderabad facility

The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections

Granules India’s Unit V facility secures USFDA EIR with NAI status

The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit

Medanta to operate and manage 750 bed super speciality hospital in Pitampura, New Delhi

Medanta is expected to incur a project capex of ~Rs. 600 crores in next 3-4 years

Alembic Pharmaceuticals Q2 FY25 PAT up 12% to Rs. 153 Cr

US Generics grew 5% to Rs. 467 Crores for the quarter

Biocon reports Q2 FY25 net loss at Rs. 16 Cr

Revenue at Rs 3,623 crore, EBITDA at Rs 718 crore

USFDA inspection of Shilpa Medicare Unit VI at Bengaluru

The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature