Aarti Drugs receives EIR from USFDA for Tarapur API facility

This facility is considered to be in a minimally acceptable state of compliance with regard to current GMP

Alembic Pharmaceuticals receives USFDA final approval for Divalproex Sodium Delayed-Release Capsules

Divalproex Sodium Delayed-Release Capsules USP, 125 mg have an estimated market size of US$ 61.1 million for twelve months ending September 2024 according to IQVIA

Briefs: Gandhar Oil Refinery India, FDC and Apitoria Pharma

FDC Ltd has received final approval from USFDA for the company's Abbreviated New Drug Application (ANDA) for Cefixime 400 mg Tablets

USFDA approves Encorafenib plus Cetuximab and Chemo in BRAF V600E-positive mCRC

Accelerated approval is based on 61% overall response rate compared to 40% in control arm in the

Sterling Biotech to start world’s first precision fermentation-based dairy protein factory in Gujarat

This facility marks a significant milestone in transforming the global food industr

Zydus receives final approval from USFDA for Lidocaine and Prilocaine Cream USP

Lidocaine and Prilocaine cream had annual sales of US $22.05 million in the United States (IQVIA MAT October 2024)

Caplin Steriles gets USFDA approval for Difluprednate Ophthalmic emulsion

Difluprednate Ophthalmic Emulsion, 0.05% is a topical corticosteroid that is indicated in the treatment of inflammation and pain associated with ocular surgery

Granules India FDA approval for ADHD treatment

Merck announces FDA acceptance of biologics license application for Clesrovimab

An investigational long-acting monoclonal antibody designed to protect infants from RSV disease during their first RSV season

Acoramidis receives positive CHMP opinion for treatment of transthyretin amyloid cardiomyopathy

Final decision from the European Commission is anticipated within the coming months