Shilpa Biologics Dharwad site gets European GMP certification
NMC Inspection
Shilpa Medicare has announced that its Biologics arm, Shilpa Biologics site at Dharwad, Karnataka, has received its European GMP certification for manufacturing of test batches.
The certification was based on the inspection conducted by the competent authority of Austria between 18 Feb to 20 Feb 2025.
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.”
Medical Dialogue team had earlier reported that the company had received approval from the USFDA for Varenicline Tablets, 0.5 and 1 mg. Shilpa’s product had been approved as a generic version to the innovator - Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V.
Shilpa Medicare is a global pharmaceutical company specializing in contract development and manufacturing services for small and large molecules. The company offers comprehensive solutions from discovery to commercial supply. Shilpa Medicare operates world-class R&D and manufacturing facilities, serving partners across North America, Europe, and Asia.
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