Shandong Xinhua Pharmaceutical Company Limited has recently received the Drug Registration Certificate of levamlodiping besylate tablets approved and issued by the National Medical Products Administration of the People's Republic of China. Relevant information is now announced as follows: (i) Basic information Drug name: Levamlodiping besylate tablets Dosage form: Tablet Specifications: 2.5mg (calculate by CHClNO) Drug category: Prescription drugs Registration category: Class 4 chemicals Holder of the marketing license: Shandong Xinhua Pharmaceutical Company Limited Application matter: Drug registration (Domestic production) Approval number: CYHS2200840CYHB2301971 Drug approval number: Guoyao Zhunzi () H20234614 Notification number: 2023S01963 Review conclusion: According to the Pharmaceutical Administration Law of the People's Republic of China and applicable regulation, upon review, the Product conforms to applicable requirements for drug registration, and the drug registration certificate has been issued. The standard of quality, product instructions and labelling as well as the production process concerning the Product 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.