Shandong Xinhua Pharmaceutical Company Limited has received the Drug Registration Certificate of memantine hydrochloride tablets approved and issued by the National Medical Products Administration of the People's Republic of China. Relevant information is now announced as follows: Drug name: Memantine hydrochloride tablets, Dosage form: Tablets, Specifications: 10mg, Drug category: Prescription drugs, Registration category: Class 4 chemicals, Applicant: Shandong Xinhua Pharmaceutical Company Limited, Application matter: Drug registration (Domestic production), Approval number: CYHS2101813,CYHB2301401, Drug registration standard number: YBH21152023, Certificate number: 2024S00079, Drug approval number: Guoyao Zhunzi H20243056, Review conclusion: According to the Pharmaceutical Administration Law of the People's Republic of China and application regulation, upon review, the Product conforms to the relevant requirements of drug registration, and the drug registration certificate has been issued. The standard of quality, instructions, labels, and production process shall be consummated in accordance with relevant documentation.

Pharmaceutical production enterprises are required to meet requirements of pharmaceutical production quality management standards prior to the production and sale of drugs.