Granules India’s Gagillapur facility completes USFDA inspection with six observations

The recent inspection covered both cGMP and PAI processes

Briefs: Ami Organics and Dr. Reddy’s Laboratories

Ami informs that PMDA Japan has issued Inspection Result Report declaring the Sachin facility as a Good Manufacturing Practices (GMP) compliant.

Ifinatamab Deruxtecan continues to demonstrate promising response rates for lung cancer in Phase 2 Trial

Objective response rate of 54.8% seen with Daiichi Sankyo and Merck’s ifinatamab deruxtecan at 12 mg/kg dose in pretreated patients

Nanoform and Celanese collaborate for biologics delivery through small implants

The companies will combine Nanoform’s Biologics platform with the Celanese VitalDose Drug Delivery platform to further optimize controlled release of biologics

Strides receive USFDA approval for Theophylline ER tablets, 300 mg and 450 mg

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug

Sun Pharma and Moebius Medical granted FTD to MM-II for treatment of osteoarthritis knee pain

This Fast Track Designation will enable FDA to review MM-II in an expedited manner, is an important milestone in the development of MM-II

Alembic Pharmaceuticals receives USFDA final approval for Albendazole Tablets USP, 200 mg

Akums appoints Shantanu R Chobhe as Corporate Quality Assurance Head

Chobhe brings over 30 years of extensive experience in quality and regulatory management within the pharmaceutical industry

AstraZeneca advances ambition to improve standards of care in multiple cancer types

Presidential Symposium for NIAGARA will highlight practice-changing impact of a perioperative Imfinzi-based regimen in bladder cancer

Siegfried opens quality control lab in Minden

The new facility further improves the operational efficiency and readies the site for the completion of the new large-scale production plant