Shilpa Biologicals Activates GMP-Certified ADC Manufacturing Hub in Dharwad, India
Shilpa Biologicals, the biologics arm of Raichur-based Shilpa Medicare Ltd., has formally activated its antibody–drug conjugate (ADC) drug substance manufacturing facility in Dharwad, India. The plant is currently...
Government Proposes Faster Regulatory Approvals for Medical Device Manufacturers
India's Ministry of Health and Family Welfare has published draft amendments to the Medical Devices Rules, 2017, via G.S.R. 515(E) in the Extraordinary Gazette...
No free passes: FDA tightens rule against Foreign Tobacco Manufactures
The U.S. Food and Drug Administration (FDA) issued a proposed rule aimed at strengthening oversight of foreign tobacco product manufacturers and blocking illegal products...
CDSCO orders SUGAM Portal for Vaccine Post-Approval Applications from July 1
The Central Drugs Standard Control Organization (CDSCO) has announced that all applications for Post-Approval Changes in Registration Certificates and Import Licences for Human Vaccines...
Government Proposes New Rules to Reduce Wastage of Imported Medicines
The Union Ministry of Health and Family Welfare has issued a draft amendment to Rule 31 of the Drugs Rules, 1945, aimed at simplifying...
NPPA Launches Unified Digital Platform Integrating Pharma Jan Samadhan with Pharma Sahi Daam
In a major boost to citizen-centric digital governance, the National Pharmaceutical Pricing Authority (NPPA), Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, has officially...
