GENERAL
US FDA Expands Glenmark RYALTRIS Approval To Children Above 6 Years
Glenmark Specialty S A has received approval from the US Food and Drug Administration (US FDA) to expand the use of its allergy treatment RYALTRIS nasal spray for pediatric patients aged 6 to less than 12 years suffering from Seasonal Allergic Rhinitis (SAR). The approval broadens the eligible patient population for the drug in the […]
CW Bureau
·
Jul 21, 2026
GENERAL
Shilpa Biologicals Commissions ADC Drug Substance Manufacturing Unit
Shilpa Biologicals Ltd, a material subsidiary of Shilpa Medicare Ltd, has commissioned a Good Manufacturing Practice (GMP)-compliant Antibody-Drug Conjugate (ADC) manufacturing facility designed to meet global regulatory standards. The facility is fully operational, with GMP qualification protocols currently underway, paving the way for commercial-scale operations. Integrated ADC capabilities With the commissioning of the facility, Shilpa […]
CW Bureau
·
Jun 24, 2026
GENERAL
Lupin Gets Clean Inspection Report From US FDA For Ankleshwar Plant
Pharma major Lupin has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its Ankleshwar manufacturing facility in Gujarat following the closure of a product-specific pre-approval inspection conducted between March 2 and March 7, 2026. The receipt of the EIR marks the successful […]
CW Bureau
·
May 28, 2026
