Shilpa Pharma Lifesciences Limited, a wholly-owned subsidiary of Shilpa Medicare Limited, has been awarded the Certificate of Suitability (CEP) by the European Directorate for the Quality of Medicines & Healthcare (EDQM) for its Active Pharmaceutical Ingredient (API), Teriflunomide.
Teriflunomide is a novel oral disease-modifying drug approved for treating multiple sclerosis (MS). It works by reducing specific immune cells (lymphocytes) that attack the nerves in the brain and spinal cord. This mechanism helps reduce relapses and slow the progression of physical disabilities caused by MS. Clinical trials have consistently demonstrated its efficacy and safety, making it a valuable addition to MS treatment options.
This milestone marks the 25th CEP awarded to Shilpa, reflecting the company’s expertise in developing and manufacturing APIs that meet global quality standards. The certification not only solidifies Shilpa’s position as a trusted name in the pharmaceutical industry but also enhances its footprint in the European market.
