Shilpa Pharma Lifesciences Gets EDQM CEP for Teriflunomide API in MS Treatment

Team Finance Saathi

    23/Jan/2025

What's covered under the Article:

  1. Shilpa Pharma Lifesciences receives EDQM CEP for Teriflunomide API, supporting its MS treatment line.
  2. Teriflunomide is a novel oral disease-modifying agent for multiple sclerosis with proven clinical efficacy.
  3. This marks the 25th CEP issued to Shilpa, demonstrating its commitment to global pharmaceutical standards.

Shilpa Medicare Limited, a prominent name in the pharmaceutical industry, continues to make strides in the global market. The company's 100% subsidiary, Shilpa Pharma Lifesciences Limited, has recently been granted a significant recognition in the form of the Certificate of Suitability (CEP) for its Active Pharmaceutical Ingredient (API), Teriflunomide, by the European Directorate for the Quality of Medicines & Healthcare (EDQM). This prestigious certification highlights Shilpa Pharma Lifesciences' ability to meet global standards in the development, manufacture, and supply of high-quality pharmaceutical products.

The Teriflunomide API has shown great potential as a disease-modifying agent for the treatment of multiple sclerosis (MS). MS is a chronic illness of the central nervous system, and Teriflunomide has demonstrated clinical efficacy and safety through multiple large-scale, multicenter, phase III clinical trials. This oral medication is an important addition to the growing list of treatments available for MS patients, offering a non-injectable option, which enhances its appeal and patient compliance.

Teriflunomide is believed to work by decreasing the activity of certain immune cells (lymphocytes) that can attack nerve cells in the brain and spinal cord. By doing so, it helps reduce the frequency of flare-ups (or relapses) in MS patients and may help slow the progression of physical disabilities caused by the disease. With this CEP, Shilpa Pharma Lifesciences solidifies its position as a trusted player in the pharmaceutical industry, capable of producing APIs that meet stringent global standards.

This achievement is not only a testament to Shilpa’s dedication to research and development but also demonstrates its longstanding commitment to manufacturing quality-oriented products that adhere to international guidelines. The Certificate of Suitability from EDQM is the 25th such certificate issued to Shilpa, showcasing its experience and capability in producing high-quality APIs for a variety of therapeutic areas.

The granting of the CEP for Teriflunomide aligns with Shilpa Pharma Lifesciences' broader vision of becoming a leader in the development of critical medicines that address unmet medical needs. With this certification, Shilpa can now offer its Teriflunomide API to global markets, enhancing the company's ability to serve patients and healthcare providers in countries around the world.

As Shilpa Pharma Lifesciences continues to expand its product portfolio and capabilities, this achievement further strengthens the company’s reputation and trust among stakeholders. It serves as an example of the company’s continued progress in creating innovative and effective treatments for conditions like multiple sclerosis, improving the lives of patients globally.


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