
Specialty Formulations and Active Pharmaceutical Ingredients (API) Developer
On February 10, the NMPA official website showed that Qilu Pharmaceutical's Isosorbide Nitrate Injection passed the generic drug consistency evaluation, becoming the first in China to pass the evaluation. Data from MiNe Network shows that in 2020, the sales revenue of Isosorbide Nitrate injections in Chinese public medical institutions exceeded 200 million yuan. To date, Qilu Pharmaceutical has had 94 varieties pass/be considered to have passed the consistency evaluation.
Isosorbide dinitrate is a nitrate vasodilator that achieves its therapeutic purpose by dilating venous capacitance vessels and peripheral resistance vessels, thereby reducing cardiac preload and afterload and decreasing myocardial oxygen consumption.
Data from Menet shows that in 2020, the sales of Isosorbide Nitrate Injection at the terminals of China's urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (referred to as Chinese public medical institutions) exceeded 200 million yuan. In the first half of 2021, its sales approached 140 million yuan, a year-on-year increase of 44.33%.
Sales of Isosorbide Dinitrate Injection in Chinese Public Medical Institutions (Unit: 10,000 Yuan)
Source: Terminal Competition Pattern of Public Medical Institutions in China, MiNe Network
Isosorbide Dinitrate Injection products currently marketed in China include Isosorbide Dinitrate Injection, Injectable Isosorbide Dinitrate, Isosorbide Dinitrate and Glucose Injection, and Isosorbide Dinitrate and Sodium Chloride Injection. Currently, only Qilu Pharmaceutical's Isosorbide Dinitrate Injection has passed the evaluation.
To date, Qilu Pharmaceutical has had 94 varieties (175 specifications) pass/be considered to have passed the consistency evaluation, of which 41 are the first in China to pass the evaluation, and 34 are injectables.