The Rosuvastatin Calcium Tablets of two specifications (5mg/10mg) of Zhejiang Jingxin Pharmaceutical passed the consistency evaluation in the middle of February 2018, wherein, the 5mg specification is the first tablet of its kind passing the consistency evaluation in China. The Rosuvastatin Calcium Tablets of 10mg specification of Chiatai Tianqing appeared in the list of first batch of pharmaceutical products passing the generic drug quality and efficacy consistency evaluation in China published by CFDA at the end of December 2017, which is the first product of its kind passing the consistency evaluation in China.
Rosuvastatin Calcium Tablets is a core product of Zhejiang Jingxin, and its approval this time marks that Jingxin Pharmaceutical is in the first tier on the rosuvastatin market of China with Chiatai Tianqing.
|
Enterprise name |
Variety name |
Acceptance No. |
Approved specification |
Approved time |
Original approval No. |
|
Nanjing Chiatai Tianqing Pharmaceutical Co., Ltd. |
Rosuvastatin Calcium Tablets |
CYHB1704044 |
10mg |
Dec. 2017 |
GYZ ZI H20080670 |
|
Zhejiang Jingxin Pharmaceutical Co., Ltd. |
Rosuvastatin Calcium Tablets |
CYHB1703082 |
5mg |
Feb. 2018 |
GYZ ZI H20080482 |
|
CYHB1750006 |
10mg |
Feb. 2018 |
GYZ ZI H20080483 |
Rosuvastatin: super-statin
Originally developed by AstraZeneca, Rosuvastatin Calcium Tablets was approved by FDA in 2003 to reduce risks of stroke, atrial fibrillation, and arterial revascularization of patients, and is praised as a "super-statin" owing to characteristics of potent, quick, and safe lipid lowering.
Currently, there is huge market space for the drugs for cardiovascular diseases: according to statistics, the number of relevant patients reaches 290 million in China, and the prevalence is in the rising stage. Statins dominate among the multiple lipid-lowering products. The proportion of statins in the lipid-lowering products exceeded 84% in 2016, wherein, the atorvastatin and rosuvastatin were the major products on the statins market.
Market pattern in China
The Rosuvastatin Calcium Tablets under AstraZeneca was approved to enter the Chinese market in 2006, with the trade name of Crestor of which the patent has expired. By the date of this article, pharmaceutical enterprises with the production approval for Rosuvastatin Calcium Tablets in China include: Lunan Better Pharmaceutical, Zhejiang Jingxin Pharmaceutical, and Jiangsu Chiatai Tianqing, etc., with the main dosage forms of tablet, capsule, and dispersible tablet.
Wherein, enterprises with the production approval for both API and preparation include Zhejiang Jingxin Pharmaceutical, Zhejiang Hisun Pharmaceutical, and Jiangsu Chitai Tianqing; Lunan Better possesses rosuvastatin calcium dispersible table...
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