Core Viewpoint - The announcement by the company regarding the addition of a new pharmaceutical excipient product, Mannitol Core, is expected to positively impact the company's operations in the coming years [2]. Group 1: Product Details - The newly added product, Mannitol Core, has received the registration number F20250000241 from the National Medical Products Administration [1]. - As of the announcement date, the company has a total of 47 products with CDE registration numbers [1]. - Mannitol Core is a white or off-white spherical pellet made from D-mannitol and other excipients, primarily used as a carrier for enteric-coated micro-pellets and controlled-release micro-pellets [1]. Group 2: Product Features - Mannitol Core serves as an ideal platform for drug layering due to its smooth surface and uniform particle size distribution, ensuring even and secure drug layering [1]. - It acts as an inert core for preparing controlled-release micro-pellets, allowing the release characteristics to be primarily controlled by the coating membrane [1]. - The product improves taste, as mannitol has a cooling sweetness and produces a cooling sensation upon dissolution [1]. - It enables the preparation of compound formulations, allowing different drugs to be loaded onto separate batches of Mannitol Core, thus avoiding incompatibility between different drug components and achieving varied release rates [1]. - Mannitol Core can also be used directly as an osmotic diuretic [1].

山河药辅（300452）(300452.SZ)公告，公司新增1种药用辅料产品：甘露醇丸芯获得国家药品监督管理 局药品审评中心(简称"CDE")的登记号，为F20250000241。甘露醇丸芯是由D-甘露糖醇及其他辅料制成 的白色或类白色球形小丸，主要用作肠溶微丸制剂和缓控释微丸制剂的载体，也可直接作为药物微丸。 ...

Core Viewpoint - Shanhe Pharmaceutical Excipients Co., Ltd. has recently received a registration number for a new pharmaceutical excipient product, Mannitol Pill Core, from the National Medical Products Administration (NMPA) [1] Company Summary - Shanhe Pharmaceutical Excipients has a total of 47 products that have received registration numbers from the NMPA as of the announcement date [1] - The newly registered Mannitol Pill Core is made from D-mannitol and other excipients, and is primarily used as a carrier for enteric-coated micro-pellets and sustained-release micro-pellets, and can also be used directly as a drug micro-pellet [1]

Core Viewpoint - The company Shanhe Pharmaceutical Auxiliary (300452.SZ) has announced the registration of a new pharmaceutical excipient product, Mannitol Core, with the National Medical Products Administration (NMPA) [1] Group 1 - The newly registered product, Mannitol Core, has the registration number F20250000241 [1] - Mannitol Core is composed of D-mannitol and other excipients, characterized as white or off-white spherical granules [1] - The primary applications of Mannitol Core include serving as a carrier for enteric-coated microgranules and sustained-release microgranules, and it can also be used directly as a drug microgranule [1]