Our Company's Alpha-Lipoic Acid API Granted EU CEP Certificate

Our company's manufactured Alpha-Lipoic Acid Active Pharmaceutical Ingredient (API) has officially passed the rigorous review by the European Directorate for the Quality of Medicines & HealthCare (EDQM) and successfully obtained the European Union Certificate of Suitability (CEP) (Certificate No. CEP 2023-359- Rev 00).

· Internationally Recognized Certification: The CEP certification is the mandatory regulatory pathway for APIs to enter the EU market. It is recognized by over 35 international regulatory agencies worldwide, including the European Medicines Agency (EMA) and the World Health Organization (WHO).

· Global Endorsement of Quality: This certificate verifies that our Alpha-Lipoic Acid manufacturing process, impurity control, and stability data consistently comply with European Union Good Manufacturing Practice (GMP) standards, demonstrating internationally competitive quality.

· Robust Supply Chain Assurance: Our stable supply and reliable quality support customers in accelerating the development, regulatory filing, and market approval of their finished dosage form (FDF) products.

Our company will continue to uphold the "Quality by Design (QbD)" principle. Taking the CEP certification as a new starting point, we will deepen our global compliance strategy to provide domestic and international partners with safe, reliable, and compliant Alpha-Lipoic Acid API. Together, we will advance the internationalization of high-end pharmaceutical products.