Shilpa Medicare Limited’s 100% subsidiary, Shilpa Pharma Lifesciences Limited received certificate of suitability (CEP) from EDQM (European Directorate for the Quality of Medicines & Healthcare) for API, Teriflunomide.

Teriflunomide is a novel disease-modifying agent that was approved for use in the treatment of multiple sclerosis (MS). Teriflunomide has demonstrated clinical efficacy and safety in a number of large, multicenter, phase III clinical trials and is an attractive agent to add to the growing repertoire of available treatments for MS, as it has the benefit of oral administration.

Teriflunomide is thought to work by decreasing certain immune system cells (lymphocytes) which can attack the nerves in the human brain and spinal cord. This helps decrease the number of flare-ups (relapses) and may help slow down physical problems caused by MS.

This certificate is the 25th CEP issued by EDQM to Shilpa, which showcases our continued expertise and commitment to develop, manufacture and supply quality oriented products of global standards.