Shandong Xinhua Pharmaceutical Company Limited received the Drug Registration Certificate for its pregabalin capsules (75mg,150mg) (hereinafter referred to as the "Product") approved and issued by the National Medical Products Administration. Relevant information is now announced as follows: Drug name: Pregabalin capsules, Dosage form: Capsules Specifications: 150mg,75mg, Drug category:Prescription drugs, Registered classification: Class 4 chemicals Applicant: Shandong Xinhua Pharmaceutical Company Limited, Application matter: Drug registration (Domestic production), Case number: CYHS2200879CYHS2200880 Drug approval number: Guoyaozhunzi H20243976Guoyaozhunzi H20243977, Certificate number: 2024S011422024S01143, Review conclusion: In accordance with the Pharmaceutical Administration Law of the People's Republic of China () and relevant regulation, upon review, the Product conforms to the applicable requirements of drug registration, and the drug registration certificate has been issued. The standard of quality, product instructions, labelling, as well as 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.