Drug Approval | December 17, 2025
Lupin receives EIR from USFDA for Nagpur injectable facility
The EIR was issued following an inspection of the facility from September 8 to September 16, 2025
The EIR was issued following an inspection of the facility from September 8 to September 16, 2025
Convenient subcutaneous option has potential to reach more patients with same clinical benefits as Saphnelo IV infusion
The reform is set to modernise how medicines are developed, authorised, and made available across the EU
Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility
The inspection concluded with one minor observation in Form 483
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
The new site will produce next-generation synthetic medicine active pharmaceutical ingredients
The partnership also allows both companies to explore CR-001 and SKB105 as monotherapies and in combination
Captured microbes are then neutralized on engineered microbicidal surfaces
VitiPure serves as essential solubilizers, emulsifiers, and bioavailability enhancers in drug formulations
Subscribe To Our Newsletter & Stay Updated
