Good news! Nifedipine Sustained-release Tablets (Ⅰ) of Lukang Saite Company passed the consistency evaluation of generic drugs!

Release time:2023-09-12

The application for consistency evaluation of Nifedipine Sustained-release Tablets (I) (10mg) of Lukang Saite Company was approved by NMPA and was officially approved on August 31.

 

NMPA

Notification of approval of supplementary drug application

    

Drug Name

CADN: 硝苯地平緩釋片(I

English drug name: Nifedipine Sustained-release Tablets (I)

dosage form

tablet

Registration classification

Chemical drugs

specification

10mg

The original drug approval number

GUO YAO ZHUN ZI H20094073

packing specification

refer to attachment

Drug registration standard number

 

 

Nifedipine sustained release tablets (I) are used for the treatment of essential hypertension. They are calcium channel blocking drugs, which can block calcium ions from entering cells through the channels on the membrane of myocardium or vascular smooth muscle. By interfering with the internal flow of calcium ions, the level of intracellular calcium ions is reduced, thereby changing myocardial contractility and vascular tension, reducing systemic vascular tension and decreasing blood pressure.

The passing of the consistency evaluation of Nifedipine Sustained-release Tablets (I) (10mg) of Lukang Saite Company has enriched the company's cardiovascular and cerebrovascular product lines, further enhanced the company's competitiveness and demonstrated the company's R&D and quality control level, which is another significant achievement of Lukang Saite Company in improving the quality and efficacy consistency of generic drugs.