Alembic receives USFDA final approval for Nelarabine Injection, 250 mg/50 mL

Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia

Dabur Q1 FY25 consolidated net profit up 8% at Rs 500 Cr

Q1 Consolidated operating profit Up 8.3%; revenue grows 7% to Rs 3,349 crore

Lupin receives approval from USFDA for Emtricitabine and Tenofovir Alafenamide Tablets

This product will be manufactured at Lupin’s Nagpur facility in India and will be supplied to low and middle-income countries

Bayer submits NDA to USFDA for elinzanetant for the treatment of VMS associated with menopause

The New Drug Application (NDA) includes data from the Phase III studies OASIS 1, 2 and 3 - showing elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms over 12 weeks compared to placebo

Barentz acquires Anshul Life Sciences to strengthen India portfolio

The acquisition will further strengthen Barentz’ position in India creating a leading life science distribution platform

Fischer MVL and Bio Angle Vacs partner to launch livestock and aquaculture vaccines to India

BAV has revolutionized the animal vaccination industry with its ground-breaking delivery methods that prioritize quality, safety, and efficacy

USFDA completes inspection at Biocon Biologics’ facilities in Bengaluru

The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants

Merck Life Science inks MoU with ICAR-CIFT, Kochi for research in fishing process

Briefs: Indoco Remedies and Alembic Pharmaceuticals

Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe

USFDA inspects Gland Pharma’s Dundigal facility

The inspection was concluded with two 483 observations