Company Advances in Regulatory Compliance with Filing of US DMFs and CEPs for APIs

Company Advances in Regulatory Compliance with Filing of US DMFs and CEPs for APIs

• Year: 2021
• January 13, 2021

The company has made significant strides in regulatory compliance by filing Drug Master Files (DMFs) with the U.S. Food and Drug Administration (FDA) and Certificates of Suitability (CEPs) with the European Directorate for the Quality of Medicines (EDQM) for its Active Pharmaceutical Ingredients (APIs). These filings are crucial steps in ensuring the safety, efficacy, and quality of the company's products in regulated markets. This achievement not only strengthens the company's position in the global pharmaceutical industry but also underscores its commitment to adhering to the highest regulatory standards for its API offerings.