Europe (AGES, Austria) inspects Shilpa Biologicals’ Dharwad site
Drug Approval

Europe (AGES, Austria) inspects Shilpa Biologicals’ Dharwad site

he inspection covering the sterile drug product filling and packaging line, quality systems and quality control laboratories concluded compliance with the principles and guidelines of Good Manufacturing Practice

  • By IPP Bureau | May 06, 2025

Shilpa Medicare's Biologics arm Shilpa Biologics site at Dharwad, Karnataka, has received its European GMP certification for manufacturing of test batches based on the inspection between 18 Feb to 20 Feb 2025, conducted by the competent authority of Austria. The inspection covering the sterile drug product filling and packaging line, quality systems and quality control laboratories concluded compliance with the principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572.

Dr. Sridevi Khambhampaty, CEO of Shilpa Biologics commented "This inspection outcome affirms our commitment to global quality standards and assures reliable outcomes for our customers."

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