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Sign in to subscribeRosuvastatin Calcium and Ezetimibe Tablets (I)
As of 13 November 2026, for Rosuvastatin Calcium and Ezetimibe Tablets (I), 15 applications are listed as under review at China's CDE; 5 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 25 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 2 applicationsNotification delivery: 1 application
Current coverage may be incomplete
Which companies are listed, and at what stages?
Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.
Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Unverified drug names retain the Chinese source name with a No verified English name marker. Other Chinese free text is not displayed; use the source links or source-name columns in CSV exports.
Catalogue holders25View records ↓
Under-review filings15View records ↓
This year’s generic filers5View records ↓
NHSA approval numbers22View records ↓
API companies with A status0View records ↓
Chemical-drug catalogue
Loaded records: 25 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 24 in the new chemical-registration-classification generic category. Category counts may overlap.
| Marketing authorization holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| You Hui Pharma (Beijing) Co., Ltd. romanized | Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized | 国药准字H20265561 | 2026/08/04 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Qilu Pharmaceutical (Hainan) Co., Ltd | Qilu Pharmaceutical (Hainan) Co., Ltd | 国药准字H20265273 | 2026/07/21 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20265225 | 2026/07/21 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Rui Hua (Zhong Shan) Pharmaceutical Co., Ltd. romanized | 国药准字H20265028 | 2026/06/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Qidu Pharmaceutical Co., Ltd. | Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized | 国药准字H20264918 | 2026/06/23 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H20264978 | 2026/06/23 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Li Tai Er Pharma Co., Ltd. romanized | Jiangsu Li Tai Er Pharma Co., Ltd. romanized | 国药准字H20264955 | 2026/06/23 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H20264908 | 2026/06/23 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Changzhou Shi Yang Guang Pharma Co., Ltd. romanized | Changzhou Shi Yang Guang Pharma Co., Ltd. romanized | 国药准字H20264953 | 2026/06/23 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangxi Shimei Pharmaceutical Co., Ltd | Jiangxi Shimei Pharmaceutical Co., Ltd | 国药准字H20264748 | 2026/06/10 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20264317 | 2026/05/12 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | 国药准字H20264255 | 2026/05/07 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20264010 | 2026/04/14 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Tian Da Pharma (Zhuhai) Co., Ltd. romanized | Tian Da Pharma (Zhuhai) Co., Ltd. romanized | 国药准字H20264004 | 2026/04/14 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20263570 | 2026/03/10 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20263420 | 2026/02/10 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Topfond Pharmaceutical Co., Ltd. | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20256277 | 2025/12/16 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Nord Pharmaceutical Co., Ltd | Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | 2025/07/08 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Foyou Pharma CO.,LTD | Beijing Foyou Pharma CO.,LTD | 国药准字H20253967 | 2025/04/22 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Sanofi-Aventis Ireland Limited T/A SANOFI | Sanofi Ilac Sanayi ve Ticaret Anonim Sirketi | 国药准字HJ20230147 | 2023/12/26 | See source | Imported originator drug | CDE |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20263565 | 2026/03/10 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20254910 | 2025/07/22 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Bei Da Pharmaceuticals Co., Ltd. romanized | Bei Da Pharmaceuticals Co., Ltd. romanized | 国药准字H20266204 | 2026/10/13 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Shang Zhong He Biopharmaceuticals Co., Ltd. romanized | Da Tong Pharmaceutical (Zhongguo) Co., Ltd. romanized | 国药准字H20265754 | 2026/08/25 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized | Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanized | 国药准字H20265978 | 2026/09/15 | See source | Generic approved under the new chemical-drug registration classification | CDE |
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
NHSA drug codes
Loaded records: 22 distinct approval numbers and 22 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253967 | See source | Category B | XC10BAR128A001010100177 | NHSA |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20265225 | See source | Category B | XC10BAR128A001010101397 | NHSA |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20263565 | See source | Category B | XC10BAR128A001010101606 | NHSA |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20264010 | See source | Category B | XC10BAR128A001010102013 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20254910 | See source | Category B | XC10BAR128A001010102763 | NHSA |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H20256277 | See source | Category B | XC10BAR128A001010103098 | NHSA |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20265028 | See source | Category B | XC10BAR128A001010104131 | NHSA |
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H20264918 | See source | Category B | XC10BAR128A001010104145 | NHSA |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20264317 | See source | Category B | XC10BAR128A001010104606 | NHSA |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H20264978 | See source | Category B | XC10BAR128A001010104658 | NHSA |
| Jiangxi Shimei Pharmaceutical Co., Ltd | 国药准字H20264748 | See source | Category B | XC10BAR128A001010105356 | NHSA |
| Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H20265273 | See source | Category B | XC10BAR128A001010105847 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20263570 | See source | Category B | XC10BAR128A001010106632 | NHSA |
| Jiangsu Li Tai Er Pharma Co., Ltd. romanized | 国药准字H20264955 | See source | Category B | XC10BAR128A001010182291 | NHSA |
| Sanofi-Aventis Ireland Limited T/A SANOFI | 国药准字HJ20230147 | See source | Category B | XC10BAR128A001010182826 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001010183521 | NHSA |
| Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264908 | See source | Category B | XC10BAR128A001010184135 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253967 | See source | Category B | XC10BAR128A001010200177 | NHSA |
| Changzhou Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20265225 | See source | Category B | XC10BAR128A001010201397 | NHSA |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20263565 | See source | Category B | XC10BAR128A001010201606 | NHSA |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20264010 | See source | Category B | XC10BAR128A001010202013 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20254910 | See source | Category B | XC10BAR128A001010202763 | NHSA |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H20256277 | See source | Category B | XC10BAR128A001010203098 | NHSA |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20264317 | See source | Category B | XC10BAR128A001010204606 | NHSA |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H20264978 | See source | Category B | XC10BAR128A001010204658 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20263570 | See source | Category B | XC10BAR128A001010206632 | NHSA |
| Sanofi-Aventis Ireland Limited T/A SANOFI | 国药准字HJ20230147 | See source | Category B | XC10BAR128A001010282826 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001010283521 | NHSA |
| Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264908 | See source | Category B | XC10BAR128A001010284135 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253967 | See source | Category B | XC10BAR128A001010300177 | NHSA |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20263565 | See source | Category B | XC10BAR128A001010301606 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20254910 | See source | Category B | XC10BAR128A001010302763 | NHSA |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H20256277 | See source | Category B | XC10BAR128A001010303098 | NHSA |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20264317 | See source | Category B | XC10BAR128A001010304606 | NHSA |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H20264978 | See source | Category B | XC10BAR128A001010304658 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20263570 | See source | Category B | XC10BAR128A001010306632 | NHSA |
| Sanofi-Aventis Ireland Limited T/A SANOFI | 国药准字HJ20230147 | See source | Category B | XC10BAR128A001010382826 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001010383521 | NHSA |
| Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264908 | See source | Category B | XC10BAR128A001010384135 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253967 | See source | Category B | XC10BAR128A001010400177 | NHSA |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20263565 | See source | Category B | XC10BAR128A001010401606 | NHSA |
| ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H20264978 | See source | Category B | XC10BAR128A001010404658 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20263570 | See source | Category B | XC10BAR128A001010406632 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001010483521 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20263570 | See source | Category B | XC10BAR128A001010506632 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001010583521 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20263570 | See source | Category B | XC10BAR128A001010606632 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001010683521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001010783521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001010883521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001010983521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001011083521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001011183521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001011283521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001011383521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001011483521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001011583521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001011683521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001011783521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001011883521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001011983521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001012083521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001012183521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001012283521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001012383521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001012483521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001012583521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001012683521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001012783521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001012883521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001012983521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001013083521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001013183521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001013283521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001013383521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001013483521 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20254797 | See source | Category B | XC10BAR128A001013583521 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20254910 | See source | Category B | XC10BAR128A001020102763 | NHSA |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20265028 | See source | Category B | XC10BAR128A001020104131 | NHSA |
| Tian Da Pharma (Zhuhai) Co., Ltd. romanized | 国药准字H20264004 | See source | Category B | XC10BAR128A001010100560 | NHSA |
| Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized | 国药准字H20265978 | See source | Category B | XC10BAR128A001010104043 | NHSA |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20263420 | See source | Category B | XC10BAR128A001010109568 | NHSA |
| Changzhou Shi Yang Guang Pharma Co., Ltd. romanized | 国药准字H20264953 | See source | Category B | XC10BAR128A001010109665 | NHSA |
| You Hui Pharma (Beijing) Co., Ltd. romanized | 国药准字H20265561 | See source | Category B | XC10BAR128A001010183203 | NHSA |
| Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized | 国药准字H20265978 | See source | Category B | XC10BAR128A001010204043 | NHSA |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20263420 | See source | Category B | XC10BAR128A001010209568 | NHSA |
| Changzhou Shi Yang Guang Pharma Co., Ltd. romanized | 国药准字H20264953 | See source | Category B | XC10BAR128A001010209665 | NHSA |
| You Hui Pharma (Beijing) Co., Ltd. romanized | 国药准字H20265561 | See source | Category B | XC10BAR128A001010283203 | NHSA |
| Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized | 国药准字H20265978 | See source | Category B | XC10BAR128A001010304043 | NHSA |
| Changzhou Shi Yang Guang Pharma Co., Ltd. romanized | 国药准字H20264953 | See source | Category B | XC10BAR128A001010309665 | NHSA |
| You Hui Pharma (Beijing) Co., Ltd. romanized | 国药准字H20265561 | See source | Category B | XC10BAR128A001010383203 | NHSA |
| Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized | 国药准字H20265978 | See source | Category B | XC10BAR128A001010404043 | NHSA |
| Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized | 国药准字H20265978 | See source | Category B | XC10BAR128A001010504043 | NHSA |
| Tian Da Pharma (Zhuhai) Co., Ltd. romanized | 国药准字H20264004 | See source | Category B | XC10BAR128A001020100560 | NHSA |
Approval numbers and companies are deduplicated separately; packaging records remain individually listed. An empty insurance class means it is unstated. NHSA codes supply no approval date and do not establish the outcome of an acceptance number.
Current under-review applications
Loaded records: 15 filings and 15 distinct first applicants.
Generic 15
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Kang Pu Pharma Co., Ltd. romanized | CYHS2503375 | Generic | 2025/09/12 | Not stated by source | CDE |
| Zhejiang Ying Ge Lai Pharmaceutical Co., Ltd. romanized | CYHS2602446 | Generic | 2026/10/08 | Not stated by source | CDE |
| Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized | CYHS2601001 | Generic | 2026/04/29 | Not stated by source | CDE |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | CYHS2502442 | Generic | 2025/07/09 | Not stated by source | CDE |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED; Nanjing Ji Cui Ji Ding Pharmaceuticals Co., Ltd. romanized | CYHS2502989 | Generic | 2025/08/15 | Not stated by source | CDE |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | CYHS2504493 | Generic | 2025/12/31 | Not stated by source | CDE |
| Hainan Huluwa Pharmaceutical Group Co., Ltd. | CYHS2503700 | Generic | 2025/10/16 | Not stated by source | CDE |
| Guangdong Jiang Zheng Pharma Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized | CYHS2502735 | Generic | 2025/07/30 | Not stated by source | CDE |
| Yun Peng Pharmaceuticals Group Co., Ltd. romanized | CYHS2502691 | Generic | 2025/07/25 | Not stated by source | CDE |
| Sichuan Kelun Pharmaceutical Co., Ltd. | CYHS2500684 | Generic | 2025/02/09 | Not stated by source | CDE |
| Zhejiang Zhe Bei Pharma Co., Ltd. romanized; Anhui Jia He Pharma Co., Ltd. romanized | CYHS2601871 | Generic | 2026/08/03 | Not stated by source | CDE |
| Anhui Zheng Shan Bio Pharma Co., Ltd. romanized; Da Tong Pharmaceutical (Zhongguo) Co., Ltd. romanized | CYHS2600698 | Generic | 2026/03/23 | Not stated by source | CDE |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | CYHS2600552 | Generic | 2026/02/27 | Not stated by source | CDE |
| Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Shanxi De Yuan Tang Pharma Co., Ltd. romanized | CYHS2504047 | Generic | 2025/11/24 | Not stated by source | CDE |
| Shaanxi Bai Lu Pharmaceutical Co., Ltd. romanized | CYHS2502858 | Generic | 2025/08/07 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 5 filings and 5 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Zhejiang Ying Ge Lai Pharmaceutical Co., Ltd. romanized | CYHS2602446 | Generic | 2026/10/08 | Not stated by source | CDE |
| Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized | CYHS2601001 | Generic | 2026/04/29 | Not stated by source | CDE |
| Zhejiang Zhe Bei Pharma Co., Ltd. romanized; Anhui Jia He Pharma Co., Ltd. romanized | CYHS2601871 | Generic | 2026/08/03 | Not stated by source | CDE |
| Anhui Zheng Shan Bio Pharma Co., Ltd. romanized; Da Tong Pharmaceutical (Zhongguo) Co., Ltd. romanized | CYHS2600698 | Generic | 2026/03/23 | Not stated by source | CDE |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | CYHS2600552 | Generic | 2026/02/27 | Not stated by source | CDE |
API registrations
Non-component matches: 0 companies with A status and 0 I-status records. Component matches are listed separately and excluded from these counts.
| Name | Company / applicant | Registration number | Status | Name match | Source update date | View source |
|---|---|---|---|---|---|---|
| 依折麦布 · No verified English name | Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized | Y20260000100 | I | Component match (excluded from headline counts) | 2026/02/11 | CDE |
| 依折麦布 · No verified English name | Zhejiang Tian Yu Pharma Co., Ltd. romanized | Y20250000915 | I | Component match (excluded from headline counts) | 2025/10/30 | CDE |
| 依折麦布 · No verified English name | Yun Peng Pharmaceuticals Group Co., Ltd. romanized | Y20250000047 | A | Component match (excluded from headline counts) | 2026/07/20 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Anhui Yue Kang Kai Yue Pharmaceutical Co., Ltd. romanized | Y20240001436 | A | Component match (excluded from headline counts) | 2026/07/27 | CDE |
| 依折麦布 · No verified English name | Topfond Pharmaceutical Co., Ltd. | Y20240001567 | A | Component match (excluded from headline counts) | 2026/07/14 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Jiangsu Pu Run Biopharmaceuticals Co., Ltd. romanized | Y20240001404 | A | Component match (excluded from headline counts) | 2026/07/27 | CDE |
| 依折麦布 · No verified English name | Saptagir Laboratories Pvt. Ltd. | Y20240000581 | I | Component match (excluded from headline counts) | 2026/04/03 | CDE |
| 瑞舒伐他汀钙 · No verified English name | M/s. Biocon Limited | Y20240000236 | I | Component match (excluded from headline counts) | 2024/03/21 | CDE |
| 依折麦布 · No verified English name | Zhejiang Jing Sheng Pharma Co., Ltd. romanized | Y20230001252 | A | Component match (excluded from headline counts) | 2025/07/11 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Lee Pharma Limited | Y20230000872 | A | Component match (excluded from headline counts) | 2026/03/31 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Zhejiang Jiang Bei Nan Hai Pharma Co., Ltd. romanized | Y20230000714 | A | Component match (excluded from headline counts) | 2025/02/14 | CDE |
| 依折麦布 · No verified English name | Jiangsu Deyuan Pharmaceutical Co.,Ltd. | Y20230000515 | A | Component match (excluded from headline counts) | 2024/09/02 | CDE |
| 依折麦布 · No verified English name | Apitoria Pharma Private Limited | Y20230000079 | A | Component match (excluded from headline counts) | 2025/01/06 | CDE |
| 依折麦布 · No verified English name | Hetero Labs Limited | Y20220000766 | A | Component match (excluded from headline counts) | 2026/03/19 | CDE |
| 依折麦布 · No verified English name | Ya Bao Pharma Group Co., Ltd. romanized | Y20220000666 | A | Component match (excluded from headline counts) | 2026/02/10 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Zhejiang Jiang Bei Pharma Co., Ltd. romanized | Y20220000289 | A | Component match (excluded from headline counts) | 2023/09/27 | CDE |
| 依折麦布 · No verified English name | Nan Tong Chang You Pharma Technology Co., Ltd. romanized | Y20210000966 | A | Component match (excluded from headline counts) | 2023/08/29 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Zhejiang Yong Tai Pharma Co., Ltd. romanized | Y20210000962 | A | Component match (excluded from headline counts) | 2023/07/28 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Yun Peng Pharmaceuticals Group Co., Ltd. romanized | Y20210000652 | A | Component match (excluded from headline counts) | 2024/11/28 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Zhejiang Le Pu Pharma Co., Ltd. romanized | Y20210000578 | A | Component match (excluded from headline counts) | 2026/06/16 | CDE |
| 依折麦布 · No verified English name | Hanmi Fine Chemical Co., Ltd. | Y20200001433 | A | Component match (excluded from headline counts) | 2024/10/24 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Xuan Cheng Mei Nuo Hua Pharma Co., Ltd. romanized | Y20210000329 | A | Component match (excluded from headline counts) | 2022/12/16 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Hanmi Fine Chemical Co., Ltd. | Y20210000135 | A | Component match (excluded from headline counts) | 2024/08/07 | CDE |
| 依折麦布 · No verified English name | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20210000182 | A | Component match (excluded from headline counts) | 2022/11/02 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Sun Pharmaceutical Industries Limited | Y20210000168 | A | Component match (excluded from headline counts) | 2024/11/22 | CDE |
| 依折麦布 · No verified English name | Nanjing You Ke Pharmaceutical Co., Ltd. romanized | Y20210000199 | A | Component match (excluded from headline counts) | 2023/02/21 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Centrient Pharmaceuticals India Private Limited | Y20210000015 | A | Component match (excluded from headline counts) | 2025/03/15 | CDE |
| 依折麦布 · No verified English name | LUPIN LIMITED | Y20210000140 | A | Component match (excluded from headline counts) | 2025/05/17 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Hebei Guang Xiang Pharmaceutical Co., Ltd. romanized | Y20210000024 | A | Component match (excluded from headline counts) | 2026/10/23 | CDE |
| 依折麦布 · No verified English name | Shandong Bo Yuan Pharma Co., Ltd. romanized | Y20200001270 | A | Component match (excluded from headline counts) | 2024/02/27 | CDE |
| 依折麦布 · No verified English name | Synthimed Labs Private Limited | Y20200001218 | A | Component match (excluded from headline counts) | 2026/07/17 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Nan Tong Chang You Pharma Technology Co., Ltd. romanized | Y20200001398 | A | Component match (excluded from headline counts) | 2026/08/08 | CDE |
| 依折麦布 · No verified English name | Neuland Laboratories Ltd | Y20200000801 | I | Component match (excluded from headline counts) | 2020/12/22 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Lian Yun Gang Gui Ke Pharma Co., Ltd. romanized | Y20200000654 | A | Component match (excluded from headline counts) | 2026/08/18 | CDE |
| 依折麦布 · No verified English name | Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized | Y20200000290 | A | Component match (excluded from headline counts) | 2022/10/27 | CDE |
| 依折麦布 · No verified English name | Zhejiang Tian Yu Pharma Co., Ltd. romanized | Y20190000721 | A | Component match (excluded from headline counts) | 2026/01/06 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Topfond Pharmaceutical Co., Ltd. | Y20190000845 | A | Component match (excluded from headline counts) | 2026/07/17 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Hunan Jiu Dian Hong Yang Pharmaceutical Co., Ltd. romanized | Y20190021369 | A | Component match (excluded from headline counts) | 2025/11/18 | CDE |
| 瑞舒伐他汀钙 · No verified English name | MSN Laboratories Private Limited | Y20190000940 | A | Component match (excluded from headline counts) | 2025/05/24 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | Y20190009618 | A | Component match (excluded from headline counts) | — | CDE |
| 瑞舒伐他汀钙 · No verified English name | Shao Xing Jing Xin Pharma Co., Ltd. romanized | Y20190009351 | A | Component match (excluded from headline counts) | 2024/02/08 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Zhejiang Hai Zheng Pharma Co., Ltd. romanized | Y20190007514 | A | Component match (excluded from headline counts) | 2023/11/29 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Lian Yun Gang Run Zhong Pharmaceutical Co., Ltd. romanized | Y20190007277 | A | Component match (excluded from headline counts) | — | CDE |
| 瑞舒伐他汀钙 · No verified English name | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20190007037 | A | Component match (excluded from headline counts) | 2022/10/28 | CDE |
| 瑞舒伐他汀钙 · No verified English name | CSPC OUYI PHARMACEUTICAL CO., LTD. | Y20190007022 | A | Component match (excluded from headline counts) | — | CDE |
| 瑞舒伐他汀钙 · No verified English name | KRKA, d.d., Novo mesto | Y20180001608 | A | Component match (excluded from headline counts) | 2023/08/14 | CDE |
| 依折麦布 · No verified English name | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | Y20190000874 | A | Component match (excluded from headline counts) | 2026/04/30 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Xian Sheng Pharma Co., Ltd. romanized | Y20190000761 | A | Component match (excluded from headline counts) | 2025/08/14 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Zhejiang Mei Nuo Hua Drug Chemical Co., Ltd. romanized | Y20190000565 | A | Component match (excluded from headline counts) | 2026/04/13 | CDE |
| 依折麦布 · No verified English name | TEVA API INDIA PRIVATE LIMITED | Y20190000329 | A | Component match (excluded from headline counts) | 2026/07/15 | CDE |
| 依折麦布 · No verified English name | Aurobindo Pharma Limited | Y20180001595 | I | Component match (excluded from headline counts) | 2019/03/20 | CDE |
| 依折麦布 · No verified English name | Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | Y20190000024 | A | Component match (excluded from headline counts) | 2025/09/16 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Ru Yuan Dong Yang Guang Pharma Co., Ltd. romanized | Y20180001564 | A | Component match (excluded from headline counts) | 2026/04/22 | CDE |
| 依折麦布 · No verified English name | MSN Laboratories Private Limited Yi De Pharma (Shanghai) Co., Ltd. romanized | Y20180001083 | A | Component match (excluded from headline counts) | 2025/07/30 | CDE |
| 依折麦布 · No verified English name | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | Y20180001036 | I | Component match (excluded from headline counts) | 2018/08/30 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Shao Xing Jing Xin Pharma Co., Ltd. romanized | Y20180000877 | A | Component match (excluded from headline counts) | — | CDE |
| 瑞舒伐他汀钙 · No verified English name | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | Y20170001976 | A | Component match (excluded from headline counts) | 2024/08/07 | CDE |
| 瑞舒伐他汀钙 · No verified English name | AstraZeneca UK Limited | Y20170001705 | A | Component match (excluded from headline counts) | 2023/08/23 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Zhejiang Jiang Bei Pharma Co., Ltd. romanized | Y20170001629 | A | Component match (excluded from headline counts) | 2024/05/01 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Nanjing You Ke Pharmaceutical Co., Ltd. romanized | Y20170001088 | A | Component match (excluded from headline counts) | 2025/12/03 | CDE |
| 瑞舒伐他汀钙 · No verified English name | Changzhou Pharmaceutical Factory Co., Ltd. romanized | Y20170000215 | A | Component match (excluded from headline counts) | 2024/03/14 | CDE |
A/I are source statuses. Matching uses exact ingredients, salt-normalized names and maintained combination components, without fuzzy matching. A-status companies are deduplicated by the first registered company. Components are excluded from headline counts; the register does not identify the associated formulation.
What changed recently?
Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately.
Trial registration does not mean an application will follow.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
NHSA edition maintained to 2026-10-23; latest successful catalogue check: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.
-
2026/10/28Notification delivery
Fujian Dong Rui Pharmaceutical Co., Ltd. romanized
CYHS2504042
Fact date: 2026/10/28 (Publication date) · Publication date: 2026/10/28 · Site observation date: 2026/11/03
Notification delivered; the specific outcome remains to be checked.
View source · Table row 16 ↗ -
2026/10/08Accepted
Zhejiang Ying Ge Lai Pharmaceutical Co., Ltd. romanized
CYHS2602446
Fact date: 2026/10/08 · Site observation date: 2026/10/21
View source ↗ -
2026/09/11Accepted
Hebei Xin Shi Pharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
CYHB2601727
Fact date: 2026/09/11 · Site observation date: 2026/10/21
View source ↗
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/13 06:42
- Chemical-drug catalogue
- Last successful update: 2026/11/13 06:39
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
- Full API register
- Last successful update: 2026/11/13 06:41
- NHSA drug codes
- Last successful update: 2026/11/05 06:45
The fully loaded edition was maintained to 2026-10-23. Publication lags maintenance: the verified 2026-10-16 edition was published on 10-28, a 12-day gap. This is not a fixed lag for every edition.
- NMPA drug delivery notices
- Last successful update: 2026/11/12 18:32 · Current coverage may be incomplete
First index-page publication dates: 2026-10-29 to 2026-11-13; 2 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/13 08:09 · Current coverage may be incomplete
Daily collection reads new registrations. Backfill covers registration numbers from 2025 onward (CTR2025/CTR2026), not first-publication years. States are dated observations; revisions are not tracked.
This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.
Public-product searches scanned: 7/30; discovered pending details: 13. Record counts in unscanned portions remain unknown.
Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.
Fact dates are approval dates, acceptance dates, trial first-publication dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period new events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.
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