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

UK Relonchem receives marketing authorization for Levonorgestrel 1.5 mg Tablets

Relonchem Limited has received Marketing Authorization for the product Levonorgestrel 1.5 mg Tablets from UK MHRA

Aurobindo Pharma receives USFDA approval for Estradiol Vaginal Inserts USP, 10 mcg

The approved product has an estimated market size of US$ 268 million for the twelve months ending June 2024, according to IQVIA

Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar

Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance

Briefs: Alembic Pharmaceuticals and Relonchem

Alembic Pharmaceuticals receives 11 USFDA product approval during Q1 FY2025

Gland Pharma appoints Satnam Singh Loomba as COO

Before joining Gland, Loomba was associated with Shalina Labs, Harman Finochem, Aurobindo Pharma, Sun Pharmaceuticals and Ranabaxy Laboratories.

Pfizer’s Velsipity UK approval will raise competition in ulcerative colitis market, says GlobalData

The approval marks a significant milestone for the American pharmaceutical company in the field of UC

Krazati monotherapy shows significant survival benefit in KRAS G12C-mutated NSCLC Phase III Krystal -12 data

The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024

Biocon to obtain approval for diabetes drug, Liraglutide in UK

Liraglutide is a drug-device combination formulation used in the treatment of Type 2 Diabetes Mellitus

Warren Remedies commences commercial production of APIs