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As of 13 November 2026, for Roxadustat Capsules, 17 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 28 holders.
Companies, stages and changes, with each record available on this page.
No changes recorded by this site in the last 90 days
Complete CDE snapshot: 2026/11/13 06:42
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 holders28View records ↓
Under-review filings17View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers51View records ↓
API companies with A status29View records ↓
Chemical-drug catalogue
Loaded records: 28 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 27 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 |
|---|---|---|---|---|---|---|
| Zhejiang Bei De Pharma Co., Ltd. romanized | Zhejiang Bei De Pharma Co., Ltd. romanized | 国药准字H20264913 | 2026/06/23 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20264906 | 2026/06/23 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Bei De Pharma Co., Ltd. romanized | Zhejiang Bei De Pharma Co., Ltd. romanized | 国药准字H20264912 | 2026/06/23 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20264907 | 2026/06/23 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized | Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized | 国药准字H20264644 | 2026/06/03 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized | Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized | 国药准字H20264643 | 2026/06/03 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | 国药准字H20264529 | 2026/05/27 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | 国药准字H20264528 | 2026/05/27 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Anhui Pioneer Pharmaceutical Co., Ltd | Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264133 | 2026/04/21 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| Anhui Pioneer Pharmaceutical Co., Ltd | Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264132 | 2026/04/21 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangxi Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized | Jiangsu Cheng Kang Pharma Co., Ltd. romanized | 国药准字H20264034 | 2026/04/14 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20263132 | 2026/01/14 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Chongqing Yu Yang Pharma Co., Ltd. romanized | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20256140 | 2025/12/03 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Ai Wei Ge Lin Pharmaceuticals Technology Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20255835 | 2025/11/04 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Ai Wei Ge Lin Pharmaceuticals Technology Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20255834 | 2025/11/04 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhengzhou De Mai Pharma Co., Ltd. romanized | Zhejiang Hua Run San Jiu Zhong Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20255014 | 2025/07/29 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhengzhou De Mai Pharma Co., Ltd. romanized | Zhejiang Hua Run San Jiu Zhong Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20255015 | 2025/07/29 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Kun Shan Long Deng Rui Di Pharmaceutical Co., Ltd. romanized | Kun Shan Long Deng Rui Di Pharmaceutical Co., Ltd. romanized | 国药准字H20255033 | 2025/07/29 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Kun Shan Long Deng Rui Di Pharmaceutical Co., Ltd. romanized | Kun Shan Long Deng Rui Di Pharmaceutical Co., Ltd. romanized | 国药准字H20255034 | 2025/07/29 | 50mg | 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H20254104 | 2025/05/13 | 50mg | 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H20254103 | 2025/05/13 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Gowell Pharmaceutical Co., Ltd. | Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20254048 | 2025/04/30 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Gowell Pharmaceutical Co., Ltd. | Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20254047 | 2025/04/30 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20253816 | 2025/04/08 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20253815 | 2025/04/08 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized | Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20253621 | 2025/03/11 | 50mg | Not stated by source | CDE |
| Haikou Shi Pharmaceutical Factory Co., Ltd. romanized | Haikou Shi Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20253575 | 2025/03/11 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| Haikou Shi Pharmaceutical Factory Co., Ltd. romanized | Haikou Shi Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20253574 | 2025/03/11 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Jian Feng Pharma Co., Ltd. romanized | Zhejiang Jian Feng Pharma Co., Ltd. romanized | 国药准字H20253546 | 2025/03/04 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Jian Feng Pharma Co., Ltd. romanized | Zhejiang Jian Feng Pharma Co., Ltd. romanized | 国药准字H20253545 | 2025/03/04 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | Hunan Jiudian Pharmaceutical Co., Ltd | 国药准字H20253332 | 2025/02/08 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | Hunan Jiudian Pharmaceutical Co., Ltd | 国药准字H20253333 | 2025/02/08 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Wan Bang Sheng Hua Pharmaceuticals Group Co., Ltd. romanized | Jiangsu Wan Bang Sheng Hua Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20253321 | 2025/01/24 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Wan Bang Sheng Hua Pharmaceuticals Group Co., Ltd. romanized | Jiangsu Wan Bang Sheng Hua Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20253322 | 2025/01/24 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | 国药准字H20253086 | 2025/01/08 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | 国药准字H20253087 | 2025/01/08 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| Guangzhou Kang Chen Pharma Co., Ltd. romanized | Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20253093 | 2025/01/08 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Foyou Pharma CO.,LTD | Beijing Foyou Pharma CO.,LTD | 国药准字H20253115 | 2025/01/08 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Foyou Pharma CO.,LTD | Beijing Foyou Pharma CO.,LTD | 国药准字H20253116 | 2025/01/08 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Ji Chuan Pharma Group Co., Ltd. romanized | Ji Chuan Pharma Group Co., Ltd. romanized | 国药准字H20253058 | 2025/01/02 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Ji Chuan Pharma Group Co., Ltd. romanized | Ji Chuan Pharma Group Co., Ltd. romanized | 国药准字H20253059 | 2025/01/02 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. | 国药准字H20249824 | 2024/12/25 | 50mg | Not stated by source | CDE |
| Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. | 国药准字H20249825 | 2024/12/25 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Guangzhou Kang Chen Pharma Co., Ltd. romanized | Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20249771 | 2024/12/25 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20249733 | 2024/12/17 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20249731 | 2024/12/17 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20249732 | 2024/12/17 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangxi Shan Xiang Pharma Co., Ltd. romanized | Jiangxi Shan Xiang Pharma Co., Ltd. romanized | 国药准字H20249729 | 2024/12/17 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangxi Shan Xiang Pharma Co., Ltd. romanized | Jiangxi Shan Xiang Pharma Co., Ltd. romanized | 国药准字H20249730 | 2024/12/17 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20244417 | 2024/07/09 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20244418 | 2024/07/09 | 50mg | Generic approved under the new chemical-drug registration classification | CDE |
| CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. | 国药准字H20244185 | 2024/06/28 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. | 国药准字H20244184 | 2024/06/28 | 50mg | 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: 51 distinct approval numbers and 27 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253116 | 20mg | Category B | XB03XAL373E001010100177 | NHSA |
| Guangzhou Kang Chen Pharma Co., Ltd. romanized | 国药准字H20249771 | 50mg | Category B | XB03XAL373E001010100400 | NHSA |
| Ji Chuan Pharma Group Co., Ltd. romanized | 国药准字H20253058 | 20mg | Category B | XB03XAL373E001010101453 | NHSA |
| Kun Shan Long Deng Rui Di Pharmaceutical Co., Ltd. romanized | 国药准字H20255033 | 20mg | Category B | XB03XAL373E001010101533 | NHSA |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20249731 | 50mg | Category B | XB03XAL373E001010101606 | NHSA |
| Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20253321 | 20mg | Category B | XB03XAL373E001010101729 | NHSA |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20244417 | 20mg | Category B | XB03XAL373E001010102013 | NHSA |
| Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized | 国药准字H20253621 | 50mg | Category B | XB03XAL373E001010102053 | NHSA |
| Shi Yao Group Zhong Nuo Pharma (Shijiazhuang) Co., Ltd. romanized | 国药准字H20244184 | 50mg | Category B | XB03XAL373E001010102777 | NHSA |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20253086 | 20mg | Category B | XB03XAL373E001010103662 | NHSA |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20249824 | 50mg | Category B | XB03XAL373E001010104021 | NHSA |
| Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized | 国药准字H20264643 | 20mg | Category B | XB03XAL373E001010104034 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20253815 | 20mg | Category B | XB03XAL373E001010104188 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264132 | 20mg | Category B | XB03XAL373E001010104339 | NHSA |
| Zhejiang Bei De Pharma Co., Ltd. romanized | 国药准字H20264912 | 50mg | Category B | XB03XAL373E001010104612 | NHSA |
| Zhejiang Jian Feng Pharma Co., Ltd. romanized | 国药准字H20253545 | 20mg | Category B | XB03XAL373E001010104655 | NHSA |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20249733 | 50mg | Category B | XB03XAL373E001010105001 | NHSA |
| Jiangxi Shan Xiang Pharma Co., Ltd. romanized | 国药准字H20249729 | 50mg | Category B | XB03XAL373E001010105345 | NHSA |
| Haikou Shi Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20253574 | 20mg | Category B | XB03XAL373E001010105758 | NHSA |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20254103 | 20mg | Category B | XB03XAL373E001010109568 | NHSA |
| Fa Bo Jin (Zhongguo) Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | 国药准字H20180023 | 20mg | Category B | XB03XAL373E001010180523 | NHSA |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20254048 | 50mg | Category B | XB03XAL373E001010180937 | NHSA |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20253332 | 50mg | Category B | XB03XAL373E001010184106 | NHSA |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264528 | 20mg | Category B | XB03XAL373E001010184221 | NHSA |
| Hunan Ai Wei Ge Lin Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255834 | 50mg | Category B | XB03XAL373E001010184441 | NHSA |
| Zhengzhou De Mai Pharma Co., Ltd. romanized | 国药准字H20255014 | 50mg | Category B | XB03XAL373E001010184733 | NHSA |
| Jiangxi Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20264034 | 50mg | Category B | XB03XAL373E001010185211 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253116 | 20mg | Category B | XB03XAL373E001010200177 | NHSA |
| Guangzhou Kang Chen Pharma Co., Ltd. romanized | 国药准字H20249771 | 50mg | Category B | XB03XAL373E001010200400 | NHSA |
| Kun Shan Long Deng Rui Di Pharmaceutical Co., Ltd. romanized | 国药准字H20255033 | 20mg | Category B | XB03XAL373E001010201533 | NHSA |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20249731 | 50mg | Category B | XB03XAL373E001010201606 | NHSA |
| Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20253321 | 20mg | Category B | XB03XAL373E001010201729 | NHSA |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20244417 | 20mg | Category B | XB03XAL373E001010202013 | NHSA |
| Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized | 国药准字H20253621 | 50mg | Category B | XB03XAL373E001010202053 | NHSA |
| Shi Yao Group Zhong Nuo Pharma (Shijiazhuang) Co., Ltd. romanized | 国药准字H20244184 | 50mg | Category B | XB03XAL373E001010202777 | NHSA |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20249824 | 50mg | Category B | XB03XAL373E001010204021 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20253815 | 20mg | Category B | XB03XAL373E001010204188 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264132 | 20mg | Category B | XB03XAL373E001010204339 | NHSA |
| Zhejiang Bei De Pharma Co., Ltd. romanized | 国药准字H20264912 | 50mg | Category B | XB03XAL373E001010204612 | NHSA |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20249733 | 50mg | Category B | XB03XAL373E001010205001 | NHSA |
| Jiangxi Shan Xiang Pharma Co., Ltd. romanized | 国药准字H20249729 | 50mg | Category B | XB03XAL373E001010205345 | NHSA |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20254103 | 20mg | Category B | XB03XAL373E001010209568 | NHSA |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20254048 | 50mg | Category B | XB03XAL373E001010280937 | NHSA |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20253332 | 50mg | Category B | XB03XAL373E001010284106 | NHSA |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264528 | 20mg | Category B | XB03XAL373E001010284221 | NHSA |
| Hunan Ai Wei Ge Lin Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255834 | 50mg | Category B | XB03XAL373E001010284441 | NHSA |
| Zhengzhou De Mai Pharma Co., Ltd. romanized | 国药准字H20255014 | 50mg | Category B | XB03XAL373E001010284733 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253116 | 20mg | Category B | XB03XAL373E001010300177 | NHSA |
| Guangzhou Kang Chen Pharma Co., Ltd. romanized | 国药准字H20249771 | 50mg | Category B | XB03XAL373E001010300400 | NHSA |
| Kun Shan Long Deng Rui Di Pharmaceutical Co., Ltd. romanized | 国药准字H20255033 | 20mg | Category B | XB03XAL373E001010301533 | NHSA |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20249731 | 50mg | Category B | XB03XAL373E001010301606 | NHSA |
| Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20253321 | 20mg | Category B | XB03XAL373E001010301729 | NHSA |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20244417 | 20mg | Category B | XB03XAL373E001010302013 | NHSA |
| Chengdu Qing Shan Li Kang Pharma Co., Ltd. romanized | 国药准字H20253621 | 50mg | Category B | XB03XAL373E001010302053 | NHSA |
| Shi Yao Group Zhong Nuo Pharma (Shijiazhuang) Co., Ltd. romanized | 国药准字H20244184 | 50mg | Category B | XB03XAL373E001010302777 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20253815 | 20mg | Category B | XB03XAL373E001010304188 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264132 | 20mg | Category B | XB03XAL373E001010304339 | NHSA |
| Zhejiang Bei De Pharma Co., Ltd. romanized | 国药准字H20264912 | 50mg | Category B | XB03XAL373E001010304612 | NHSA |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20249733 | 50mg | Category B | XB03XAL373E001010305001 | NHSA |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20254103 | 20mg | Category B | XB03XAL373E001010309568 | NHSA |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20253332 | 50mg | Category B | XB03XAL373E001010384106 | NHSA |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264528 | 20mg | Category B | XB03XAL373E001010384221 | NHSA |
| Hunan Ai Wei Ge Lin Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255834 | 50mg | Category B | XB03XAL373E001010384441 | NHSA |
| Zhengzhou De Mai Pharma Co., Ltd. romanized | 国药准字H20255014 | 50mg | Category B | XB03XAL373E001010384733 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253116 | 20mg | Category B | XB03XAL373E001010400177 | NHSA |
| Guangzhou Kang Chen Pharma Co., Ltd. romanized | 国药准字H20249771 | 50mg | Category B | XB03XAL373E001010400400 | NHSA |
| Kun Shan Long Deng Rui Di Pharmaceutical Co., Ltd. romanized | 国药准字H20255033 | 20mg | Category B | XB03XAL373E001010401533 | NHSA |
| Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20253321 | 20mg | Category B | XB03XAL373E001010401729 | NHSA |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20244417 | 20mg | Category B | XB03XAL373E001010402013 | NHSA |
| Shi Yao Group Zhong Nuo Pharma (Shijiazhuang) Co., Ltd. romanized | 国药准字H20244184 | 50mg | Category B | XB03XAL373E001010402777 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20253815 | 20mg | Category B | XB03XAL373E001010404188 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264132 | 20mg | Category B | XB03XAL373E001010404339 | NHSA |
| Zhejiang Bei De Pharma Co., Ltd. romanized | 国药准字H20264912 | 50mg | Category B | XB03XAL373E001010404612 | NHSA |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20249733 | 50mg | Category B | XB03XAL373E001010405001 | NHSA |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20254103 | 20mg | Category B | XB03XAL373E001010409568 | NHSA |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20253332 | 50mg | Category B | XB03XAL373E001010484106 | NHSA |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264528 | 20mg | Category B | XB03XAL373E001010484221 | NHSA |
| Zhengzhou De Mai Pharma Co., Ltd. romanized | 国药准字H20255014 | 50mg | Category B | XB03XAL373E001010484733 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20253815 | 20mg | Category B | XB03XAL373E001010504188 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264132 | 20mg | Category B | XB03XAL373E001010504339 | NHSA |
| Zhejiang Bei De Pharma Co., Ltd. romanized | 国药准字H20264912 | 50mg | Category B | XB03XAL373E001010504612 | NHSA |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20249733 | 50mg | Category B | XB03XAL373E001010505001 | NHSA |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20253332 | 50mg | Category B | XB03XAL373E001010584106 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264132 | 20mg | Category B | XB03XAL373E001010604339 | NHSA |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20249733 | 50mg | Category B | XB03XAL373E001010605001 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264132 | 20mg | Category B | XB03XAL373E001010704339 | NHSA |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20249733 | 50mg | Category B | XB03XAL373E001010705001 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264132 | 20mg | Category B | XB03XAL373E001010804339 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264132 | 20mg | Category B | XB03XAL373E001010904339 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264132 | 20mg | Category B | XB03XAL373E001011004339 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264132 | 20mg | Category B | XB03XAL373E001011104339 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264132 | 20mg | Category B | XB03XAL373E001011204339 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264132 | 20mg | Category B | XB03XAL373E001011304339 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264132 | 20mg | Category B | XB03XAL373E001011404339 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264132 | 20mg | Category B | XB03XAL373E001011504339 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264132 | 20mg | Category B | XB03XAL373E001011604339 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264132 | 20mg | Category B | XB03XAL373E001011704339 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264132 | 20mg | Category B | XB03XAL373E001011804339 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253115 | 50mg | Category B | XB03XAL373E001020100177 | NHSA |
| Guangzhou Kang Chen Pharma Co., Ltd. romanized | 国药准字H20253093 | 20mg | Category B | XB03XAL373E001020100400 | NHSA |
| Ji Chuan Pharma Group Co., Ltd. romanized | 国药准字H20253059 | 50mg | Category B | XB03XAL373E001020101453 | NHSA |
| Kun Shan Long Deng Rui Di Pharmaceutical Co., Ltd. romanized | 国药准字H20255034 | 50mg | Category B | XB03XAL373E001020101533 | NHSA |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20249732 | 20mg | Category B | XB03XAL373E001020101606 | NHSA |
| Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20253322 | 50mg | Category B | XB03XAL373E001020101729 | NHSA |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20244418 | 50mg | Category B | XB03XAL373E001020102013 | NHSA |
| Shi Yao Group Zhong Nuo Pharma (Shijiazhuang) Co., Ltd. romanized | 国药准字H20244185 | 20mg | Category B | XB03XAL373E001020102777 | NHSA |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20253087 | 50mg | Category B | XB03XAL373E001020103662 | NHSA |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20249825 | 20mg | Category B | XB03XAL373E001020104021 | NHSA |
| Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized | 国药准字H20264644 | 50mg | Category B | XB03XAL373E001020104034 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20253816 | 50mg | Category B | XB03XAL373E001020104188 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264133 | 50mg | Category B | XB03XAL373E001020104339 | NHSA |
| Zhejiang Bei De Pharma Co., Ltd. romanized | 国药准字H20264913 | 20mg | Category B | XB03XAL373E001020104612 | NHSA |
| Zhejiang Jian Feng Pharma Co., Ltd. romanized | 国药准字H20253546 | 50mg | Category B | XB03XAL373E001020104655 | NHSA |
| Jiangxi Shan Xiang Pharma Co., Ltd. romanized | 国药准字H20249730 | 20mg | Category B | XB03XAL373E001020105345 | NHSA |
| Haikou Shi Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20253575 | 50mg | Category B | XB03XAL373E001020105758 | NHSA |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20254104 | 50mg | Category B | XB03XAL373E001020109568 | NHSA |
| Fa Bo Jin (Zhongguo) Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | 国药准字H20180024 | 50mg | Category B | XB03XAL373E001020180523 | NHSA |
| Sichuan Gowell Pharmaceutical Co., Ltd. | 国药准字H20254047 | 20mg | Category B | XB03XAL373E001020180937 | NHSA |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20253333 | 20mg | Category B | XB03XAL373E001020184106 | NHSA |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264529 | 50mg | Category B | XB03XAL373E001020184221 | NHSA |
| Hunan Ai Wei Ge Lin Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255835 | 20mg | Category B | XB03XAL373E001020184441 | NHSA |
| Zhengzhou De Mai Pharma Co., Ltd. romanized | 国药准字H20255015 | 20mg | Category B | XB03XAL373E001020184733 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253115 | 50mg | Category B | XB03XAL373E001020200177 | NHSA |
| Guangzhou Kang Chen Pharma Co., Ltd. romanized | 国药准字H20253093 | 20mg | Category B | XB03XAL373E001020200400 | NHSA |
| Kun Shan Long Deng Rui Di Pharmaceutical Co., Ltd. romanized | 国药准字H20255034 | 50mg | Category B | XB03XAL373E001020201533 | NHSA |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20249732 | 20mg | Category B | XB03XAL373E001020201606 | NHSA |
| Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20253322 | 50mg | Category B | XB03XAL373E001020201729 | NHSA |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20244418 | 50mg | Category B | XB03XAL373E001020202013 | NHSA |
| Shi Yao Group Zhong Nuo Pharma (Shijiazhuang) Co., Ltd. romanized | 国药准字H20244185 | 20mg | Category B | XB03XAL373E001020202777 | NHSA |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20253087 | 50mg | Category B | XB03XAL373E001020203662 | NHSA |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20249825 | 20mg | Category B | XB03XAL373E001020204021 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20253816 | 50mg | Category B | XB03XAL373E001020204188 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264133 | 50mg | Category B | XB03XAL373E001020204339 | NHSA |
| Zhejiang Bei De Pharma Co., Ltd. romanized | 国药准字H20264913 | 20mg | Category B | XB03XAL373E001020204612 | NHSA |
| Jiangxi Shan Xiang Pharma Co., Ltd. romanized | 国药准字H20249730 | 20mg | Category B | XB03XAL373E001020205345 | NHSA |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | 国药准字H20254104 | 50mg | Category B | XB03XAL373E001020209568 | NHSA |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20253333 | 20mg | Category B | XB03XAL373E001020284106 | NHSA |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264529 | 50mg | Category B | XB03XAL373E001020284221 | NHSA |
| Hunan Ai Wei Ge Lin Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255835 | 20mg | Category B | XB03XAL373E001020284441 | NHSA |
| Zhengzhou De Mai Pharma Co., Ltd. romanized | 国药准字H20255015 | 20mg | Category B | XB03XAL373E001020284733 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253115 | 50mg | Category B | XB03XAL373E001020300177 | NHSA |
| Guangzhou Kang Chen Pharma Co., Ltd. romanized | 国药准字H20253093 | 20mg | Category B | XB03XAL373E001020300400 | NHSA |
| Kun Shan Long Deng Rui Di Pharmaceutical Co., Ltd. romanized | 国药准字H20255034 | 50mg | Category B | XB03XAL373E001020301533 | NHSA |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20249732 | 20mg | Category B | XB03XAL373E001020301606 | NHSA |
| Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20253322 | 50mg | Category B | XB03XAL373E001020301729 | NHSA |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20244418 | 50mg | Category B | XB03XAL373E001020302013 | NHSA |
| Shi Yao Group Zhong Nuo Pharma (Shijiazhuang) Co., Ltd. romanized | 国药准字H20244185 | 20mg | Category B | XB03XAL373E001020302777 | NHSA |
| HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20253087 | 50mg | Category B | XB03XAL373E001020303662 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20253816 | 50mg | Category B | XB03XAL373E001020304188 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264133 | 50mg | Category B | XB03XAL373E001020304339 | NHSA |
| Zhejiang Bei De Pharma Co., Ltd. romanized | 国药准字H20264913 | 20mg | Category B | XB03XAL373E001020304612 | NHSA |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20253333 | 20mg | Category B | XB03XAL373E001020384106 | NHSA |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264529 | 50mg | Category B | XB03XAL373E001020384221 | NHSA |
| Hunan Ai Wei Ge Lin Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255835 | 20mg | Category B | XB03XAL373E001020384441 | NHSA |
| Zhengzhou De Mai Pharma Co., Ltd. romanized | 国药准字H20255015 | 20mg | Category B | XB03XAL373E001020384733 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253115 | 50mg | Category B | XB03XAL373E001020400177 | NHSA |
| Guangzhou Kang Chen Pharma Co., Ltd. romanized | 国药准字H20253093 | 20mg | Category B | XB03XAL373E001020400400 | NHSA |
| Kun Shan Long Deng Rui Di Pharmaceutical Co., Ltd. romanized | 国药准字H20255034 | 50mg | Category B | XB03XAL373E001020401533 | NHSA |
| Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20253322 | 50mg | Category B | XB03XAL373E001020401729 | NHSA |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20244418 | 50mg | Category B | XB03XAL373E001020402013 | NHSA |
| Shi Yao Group Zhong Nuo Pharma (Shijiazhuang) Co., Ltd. romanized | 国药准字H20244185 | 20mg | Category B | XB03XAL373E001020402777 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20253816 | 50mg | Category B | XB03XAL373E001020404188 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264133 | 50mg | Category B | XB03XAL373E001020404339 | NHSA |
| Zhejiang Bei De Pharma Co., Ltd. romanized | 国药准字H20264913 | 20mg | Category B | XB03XAL373E001020404612 | NHSA |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20253333 | 20mg | Category B | XB03XAL373E001020484106 | NHSA |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264529 | 50mg | Category B | XB03XAL373E001020484221 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20253816 | 50mg | Category B | XB03XAL373E001020504188 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264133 | 50mg | Category B | XB03XAL373E001020504339 | NHSA |
| Zhejiang Bei De Pharma Co., Ltd. romanized | 国药准字H20264913 | 20mg | Category B | XB03XAL373E001020504612 | NHSA |
| Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20253333 | 20mg | Category B | XB03XAL373E001020584106 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264133 | 50mg | Category B | XB03XAL373E001020604339 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264133 | 50mg | Category B | XB03XAL373E001020704339 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264133 | 50mg | Category B | XB03XAL373E001020804339 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20264133 | 50mg | Category B | XB03XAL373E001020904339 | 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: 17 filings and 9 distinct first applicants.
Generic 17
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | CYHS2503248 | Generic | 2025/09/04 | Not stated by source | CDE |
| Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized | CYHS2501521 | Generic | 2025/04/23 | Not stated by source | CDE |
| Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized | CYHS2501520 | Generic | 2025/04/23 | Not stated by source | CDE |
| Hebei Zi Wei Shan Pharmaceutical Co., Ltd. romanized | CYHS2601787 | Generic | 2026/07/27 | Not stated by source | CDE |
| Hebei Zi Wei Shan Pharmaceutical Co., Ltd. romanized | CYHS2601786 | Generic | 2026/07/27 | Not stated by source | CDE |
| Wu Hu Dao Run Pharma Co., Ltd. romanized | CYHS2600426 | Generic | 2026/02/10 | Not stated by source | CDE |
| Wu Hu Dao Run Pharma Co., Ltd. romanized | CYHS2600424 | Generic | 2026/02/10 | Not stated by source | CDE |
| Topfond Pharmaceutical Co., Ltd. | CYHS2504096 | Generic | 2025/11/28 | Not stated by source | CDE |
| Topfond Pharmaceutical Co., Ltd. | CYHS2504095 | Generic | 2025/11/28 | Not stated by source | CDE |
| Zhuhai Jian Fu Pharmaceutical Co., Ltd. romanized | CYHS2503925 | Generic | 2025/11/12 | Not stated by source | CDE |
| Zhuhai Jian Fu Pharmaceutical Co., Ltd. romanized | CYHS2503924 | Generic | 2025/11/12 | Not stated by source | CDE |
| Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized | CYHS2503373 | Generic | 2025/09/12 | Not stated by source | CDE |
| Qingdao Guo Xin Pharmaceutical Co., Ltd. romanized | CYHS2503372 | Generic | 2025/09/12 | Not stated by source | CDE |
| Hangzhou Qian Yuan Bao Ling Pharma Co., Ltd. romanized | CYHS2502848 | Generic | 2025/08/06 | Not stated by source | CDE |
| Hangzhou Qian Yuan Bao Ling Pharma Co., Ltd. romanized | CYHS2502847 | Generic | 2025/08/06 | Not stated by source | CDE |
| Shanxi Tong Da Pharma Co., Ltd. romanized | CYHS2502066 | Generic | 2025/06/11 | Not stated by source | CDE |
| Shanxi Tong Da Pharma Co., Ltd. romanized | CYHS2502065 | Generic | 2025/06/11 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 4 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Hebei Zi Wei Shan Pharmaceutical Co., Ltd. romanized | CYHS2601787 | Generic | 2026/07/27 | Not stated by source | CDE |
| Hebei Zi Wei Shan Pharmaceutical Co., Ltd. romanized | CYHS2601786 | Generic | 2026/07/27 | Not stated by source | CDE |
| Wu Hu Dao Run Pharma Co., Ltd. romanized | CYHS2600426 | Generic | 2026/02/10 | Not stated by source | CDE |
| Wu Hu Dao Run Pharma Co., Ltd. romanized | CYHS2600424 | Generic | 2026/02/10 | Not stated by source | CDE |
API registrations
Non-component matches: 29 companies with A status and 4 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 |
|---|---|---|---|---|---|---|
| 罗沙司他 · No verified English name | Yun Peng Pharmaceuticals Group Co., Ltd. romanized | Y20260000055 | I | Exact ingredient | 2026/02/10 | CDE |
| 罗沙司他 · No verified English name | Su Zhong Pharma Group Co., Ltd. romanized | Y20250000533 | I | Exact ingredient | 2025/06/04 | CDE |
| 罗沙司他 · No verified English name | Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized | Y20250000239 | A | Exact ingredient | 2026/10/14 | CDE |
| 罗沙司他 · No verified English name | Jiangxi Tong He Pharma Co., Ltd. romanized | Y20240001574 | A | Exact ingredient | 2026/06/16 | CDE |
| 罗沙司他 · No verified English name | Han Rui Pharma (Jing Men) Co., Ltd. romanized | Y20240001403 | A | Exact ingredient | 2026/09/09 | CDE |
| 罗沙司他 · No verified English name | Jiangsu Deyuan Pharmaceutical Co.,Ltd. | Y20240001421 | A | Exact ingredient | 2026/07/21 | CDE |
| 罗沙司他 · No verified English name | Hubei Tian Shu Pharma Co., Ltd. romanized | Y20240001204 | A | Exact ingredient | 2026/07/29 | CDE |
| 罗沙司他 · No verified English name | Anhui Mei Nuo Hua Drug Chemical Co., Ltd. romanized | Y20240001139 | A | Exact ingredient | 2026/05/07 | CDE |
| 罗沙司他 · No verified English name | Tianish Laboratories Private Limited (Unit-8) | Y20240000646 | I | Exact ingredient | 2024/07/29 | CDE |
| 罗沙司他 · No verified English name | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | Y20240000096 | A | Exact ingredient | 2025/09/09 | CDE |
| 罗沙司他 · No verified English name | Sichuan Ren An Pharma Co., Ltd. romanized | Y20240000015 | A | Exact ingredient | 2026/09/12 | CDE |
| 罗沙司他 · No verified English name | Shanghai Di Sai Nuo Chemical Pharmaceutical Co., Ltd. romanized | Y20230000947 | A | Exact ingredient | 2026/10/09 | CDE |
| 罗沙司他 · No verified English name | Sichuan Gowell Pharmaceutical Co., Ltd. | Y20230001147 | A | Exact ingredient | 2026/06/18 | CDE |
| 罗沙司他 · No verified English name | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | Y20230001036 | A | Exact ingredient | 2025/12/24 | CDE |
| 罗沙司他 · No verified English name | Dr. Reddy’s Laboratories Ltd. | Y20230000881 | A | Exact ingredient | 2025/07/29 | CDE |
| 罗沙司他 · No verified English name | Zhejiang Jian Feng Pharma Co., Ltd. romanized | Y20230000850 | A | Exact ingredient | 2025/10/24 | CDE |
| 罗沙司他 · No verified English name | Jiangsu Zheng Ji Pharma Co., Ltd. romanized | Y20230000769 | A | Exact ingredient | 2026/01/15 | CDE |
| 罗沙司他 · No verified English name | Shanghai He Quan Pharma Co., Ltd. romanized | Y20230000511 | A | Exact ingredient | 2024/11/21 | CDE |
| 罗沙司他 · No verified English name | Chongqing Tian Di Pharma Co., Ltd. romanized | Y20230000487 | A | Exact ingredient | 2025/08/29 | CDE |
| 罗沙司他 · No verified English name | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20230000551 | A | Exact ingredient | 2026/10/05 | CDE |
| 罗沙司他 · No verified English name | Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | Y20230000408 | A | Exact ingredient | 2024/12/20 | CDE |
| 罗沙司他 · No verified English name | Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | Y20220001200 | A | Exact ingredient | 2024/12/10 | CDE |
| 罗沙司他 · No verified English name | Ji Chuan Pharma Group Co., Ltd. romanized | Y20220001295 | A | Exact ingredient | 2025/09/11 | CDE |
| 罗沙司他 · No verified English name | Sichuan Kelun Pharmaceutical Co., Ltd. | Y20220000992 | A | Exact ingredient | 2024/09/10 | CDE |
| 罗沙司他 · No verified English name | Shandong An Hong Pharmaceutical Co., Ltd. romanized | Y20220000768 | A | Exact ingredient | 2026/06/25 | CDE |
| 罗沙司他 · No verified English name | CSPC OUYI PHARMACEUTICAL CO., LTD. | Y20220000705 | A | Exact ingredient | 2025/02/15 | CDE |
| 罗沙司他 · No verified English name | Shang Yao Kang Li (Changzhou) Pharma Co., Ltd. romanized | Y20220000483 | A | Exact ingredient | 2024/10/08 | CDE |
| 罗沙司他 · No verified English name | Beijing Foyou Pharma CO.,LTD | Y20210001299 | A | Exact ingredient | 2023/11/20 | CDE |
| 罗沙司他 · No verified English name | Xu Zhou Wan Bang Jin Qiao Pharmaceutical Co., Ltd. romanized | Y20210000682 | A | Exact ingredient | 2025/02/09 | CDE |
| 罗沙司他 · No verified English name | Jiangxi Ke Rui Pharma Co., Ltd. romanized | Y20210000730 | A | Exact ingredient | 2026/04/03 | CDE |
| 罗沙司他 · No verified English name | Xu Zhou Wan Bang Jin Qiao Pharmaceutical Co., Ltd. romanized | Y20210000109 | I | Exact ingredient | 2021/02/22 | CDE |
| 罗沙司他 · No verified English name | Sichuan Ren An Pharma Co., Ltd. romanized | Y20210000003 | A | Exact ingredient | 2024/06/22 | CDE |
| 罗沙司他 · No verified English name | Jiangsu Pu Run Biopharmaceuticals Co., Ltd. romanized | Y20200000901 | A | Exact ingredient | 2025/11/02 | CDE |
| 罗沙司他 · No verified English name | Fa Bo Jin (Zhongguo) Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | Y20190000056 | A | Exact ingredient | 2024/09/26 | 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.
- No matching records were found in the currently loaded source data; coverage dates are listed below.
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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