New Launch3 May 2025, 02:44 pm
Shilpa Medicare's Biologics Arm Receives European GMP Certification
AI Summary
Shilpa Medicare's subsidiary, Shilpa Biologicals Private Limited, has received its European GMP certification for manufacturing of test batches at its Dharwad, Karnataka site. The inspection, conducted by the competent authority of Austria between 18 Feb to 20 Feb 2025, covered the sterile drug product filling and packaging line, quality systems, and quality control laboratories. The outcome affirms Shilpa Medicare's commitment to global quality standards and reliable outcomes for customers.
Key Highlights
- Shilpa Biologics, a subsidiary of Shilpa Medicare, receives European GMP certification
- Certification based on inspection of sterile drug product filling and packaging line
- Quality systems and laboratories comply with Good Manufacturing Practice guidelines
- Outcome reflects Shilpa Medicare's commitment to global quality standards
- Shilpa Medicare specializes in contract development and manufacturing services for small and large molecules, with a strong emphasis on oncology and a growing presence in biologics