Shilpa Pharma Lifesciences receives CEP from EDQM for API, Teriflunomide
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-01-24 07:00 GMT | Update On 2025-01-24 07:00 GMT
Karnataka: Shilpa Pharma Lifesciences Limited, a 100 percent subsidiary of Shilpa Medicare Limited has 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 multiplesclerosis (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 human brain and spinal cord. This helps decrease the number of flare-ups (relapses) and may help slow down physical problems caused by MS.
Shilpa is an integrated pharmaceutical group with business interests in niche Oncology & Non-oncology APIs, Peptides, Polymers, differentiated finished dosage formulations including orally dispersible films & transdermal patches along with biological portfolio. Shilpa also provides end-to-end CDMO services to global pharmaceutical companies across all its business segments.
Read also: Shilpa Medicare-Zydus JV gets USFDA nod for Imkeldi for certain forms of leukemia, other cancers
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