海正药业：替格瑞洛原料药获得CEP证书

Core Viewpoint - The company has received the European Pharmacopoeia suitability certificate for the active pharmaceutical ingredient Ticagrelor, enabling it to enter the EU market and other markets that recognize the CEP certificate, which positively impacts its international market expansion [1] Group 1: Certification and Market Impact - The receipt of the certificate from the European Medicines Agency (EDQM) signifies that the product is qualified to enter the EU and other markets recognizing the CEP certificate [1] - The certification is expected to facilitate the company's further expansion into international markets [1] Group 2: Product Information - Ticagrelor is used for the treatment of acute coronary syndrome, with the original manufacturer being AstraZeneca [1] - Projected global sales volume for 2024 is approximately 171,705.29 kilograms, while for the period of January to September 2025, it is estimated at around 143,714.60 kilograms [1] Group 3: Application Timeline - The company submitted the application to EDQM on December 28, 2023, and recently received the CEP certificate [1]