Entrusted by Fuzhou Minhai Pharmaceutical Co., Ltd., our company has been providing pharmaceutical research, development, and agency registration services for its product "Roxatidine Acetate Hydrochloride Sustained-Release Capsules (Specifications: 75 mg, 37.5 mg)." This product is classified as Category 3 for registration and represents the first domestic application of its kind. Through the joint efforts of both parties, the Clinical Trial Approval Notice was successfully issued by the National Medical Products Administration (NMPA) on September 24, 2020. Along the way, we overcame many challenges, including low process yield and dissolution uniformity issues, and ultimately demonstrated in vivo consistency with the reference product (ALTAT®) through fed and fasting bioequivalence studies.