Subsidiary of Shandong Lukang Pharmaceutical (600789.SH), Amlodipine Hydrochloride Injection, has passed the generic drug consistency evaluation.
18/11/2024
GMT Eight
Shandong Lukang Pharmaceutical (600789.SH) announced that its holding subsidiary, Shandong Lukang Pharmaceutical Group Saite Co., Ltd. (hereinafter referred to as "Saite Company"), has received the "Drug Supplementary Application Approval Notice" (approval number: 2024B05233) issued by the National Medical Products Administration regarding the consistency evaluation of the quality and efficacy of Esmolol Hydrochloride Injection.
Esmolol hydrochloride is a ultra-short acting, cardioselective beta-adrenergic receptor blocker widely used for the treatment of supraventricular tachycardia, acute coronary syndrome, perioperative hypertension, tachycardia, myocardial ischemia, etc. This product has the advantages of high selectivity, rapid onset, short half-life, quick loss of effectiveness after discontinuation, minimal impact on cardiac hemodynamics, and significant negative inotropic effects. It is categorized as a Class B reimbursable drug under national medical insurance and a national essential medicine, belonging to clinically necessary drugs. The consistency evaluation of Saite Company's Esmolol Hydrochloride Injection will facilitate the future market expansion and sales of the product, while also accumulating beneficial experience for the subsequent consistency evaluation of generic drugs.