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Sign in to subscribeAs of 13 November 2026, for Sitagliptin Phosphate and Metformin Hydrochloride Tablets (II), 5 applications are listed as under review at China's CDE; 2 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: No longer listed under review: 2 applicationsSupplement delivery: 2 applications
Current coverage may be incomplete
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.
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 |
|---|---|---|---|---|---|---|
| Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | 国药准字H20264418 | 2026/05/19 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hubei Wu Shi Pharmaceuticals Research Institute Co., Ltd. romanized | Hubei Wu Shi Pharma Co., Ltd. romanized | 国药准字H20263985 | 2026/04/14 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | 国药准字H20264003 | 2026/04/14 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Gan Li Pharma Shandong Co., Ltd. romanized | Gan Li Pharma Shandong Co., Ltd. romanized | 国药准字H20263765 | 2026/03/31 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing SL Pharmaceutical Co., Ltd. | Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized | 国药准字H20263692 | 2026/03/25 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Wei Te Pharmaceutical Co., Ltd. romanized | Hunan Wei Te Pharmaceutical Co., Ltd. romanized | 国药准字H20255797 | 2025/10/28 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Yong Tai Pharma Co., Ltd. romanized | Zhejiang Yong Tai Pharma Co., Ltd. romanized | 国药准字H20253199 | 2025/01/14 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Kang Yuan Pharma Co., Ltd. romanized | Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 国药准字H20253074 | 2025/01/08 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Ying Ge Lai Pharmaceutical Co., Ltd. romanized | Zhejiang Ying Ge Lai Pharmaceutical Co., Ltd. romanized | 国药准字H20249536 | 2024/12/01 | 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H20244899 | 2024/09/19 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jilin Chang Bai Shan Pharma Group Co., Ltd. romanized | Jilin Chang Bai Shan Pharma Group Co., Ltd. romanized | 国药准字H20244780 | 2024/09/03 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 国药准字H20244159 | 2024/06/25 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hui Sheng Biopharmaceutical Co., Ltd. romanized | Tianjin Han Rui Pharma Co., Ltd. romanized | 国药准字H20243802 | 2024/05/21 | 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H20243710 | 2024/05/15 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | 国药准字H20243712 | 2024/05/15 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jinan Chen Xin Pharmaceuticals Technology Co., Ltd. romanized | CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | 2024/04/24 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20243400 | 2024/03/29 | 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H20233804 | 2023/06/27 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shenzhen Han Yu Pharma Co., Ltd. romanized | Shenzhen Han Yu Pharma Co., Ltd. romanized | 国药准字H20233025 | 2023/01/10 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20223873 | 2022/11/22 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H20227137 | 2022/10/21 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Tong Hua Dong Bao Pharma Co., Ltd. romanized | Tong Hua Dong Bao Pharma Co., Ltd. romanized | 国药准字H20213790 | 2021/10/19 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Guangdong Dong Yang Guang Pharma Co., Ltd. romanized | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized | 国药准字H20203440 | 2020/08/17 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| MSD Pharma (Singapore) Pte.Ltd | Patheon Puerto Rico, Inc. (Manati) | H20140775 | 2012/07/23 | See source | Imported originator drug | CDE |
| Beijing Yuan Yan Pharmaceuticals Technology Co., Ltd. romanized | Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized | 国药准字H20265990 | 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.
Loaded records: 25 distinct approval numbers and 25 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Beijing SL Pharmaceutical Co., Ltd. | 国药准字H20263692 | See source | Category B | XA10BDX223A001010100148 | NHSA |
| Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 国药准字H20253074 | See source | Category B | XA10BDX223A001010101463 | NHSA |
| MSD Merck Sharp & Dohme AG | 国药准字HJ20140775 | See source | Category B | XA10BDX223A001010104495 | NHSA |
| Hui Sheng Biopharmaceutical Co., Ltd. romanized | 国药准字H20243802 | See source | Category B | XA10BDX223A001010182963 | NHSA |
| MSD Merck Sharp & Dohme AG | 国药准字HJ20140775 | See source | Category B | XA10BDX223A001010204495 | NHSA |
| Hui Sheng Biopharmaceutical Co., Ltd. romanized | 国药准字H20243802 | See source | Category B | XA10BDX223A001010282963 | NHSA |
| Hui Sheng Biopharmaceutical Co., Ltd. romanized | 国药准字H20243802 | See source | Category B | XA10BDX223A001010382963 | NHSA |
| Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | 国药准字H20264003 | See source | Category B | XA10BDX223A001010102753 | NHSA |
| Hubei Wu Shi Pharmaceuticals Research Institute Co., Ltd. romanized | 国药准字H20263985 | See source | Category B | XA10BDX223A001010184568 | NHSA |
| Gan Li Pharma Shandong Co., Ltd. romanized | 国药准字H20263765 | See source | Category B | XA10BDX223A001010185033 | NHSA |
| Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | 国药准字H20264418 | See source | Category B | XA10BDX223A001010185553 | NHSA |
| Gan Li Pharma Shandong Co., Ltd. romanized | 国药准字H20263765 | See source | Category B | XA10BDX223A001010285033 | NHSA |
| Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | 国药准字H20264418 | See source | Category B | XA10BDX223A001020185553 | NHSA |
| Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | 国药准字H20264418 | See source | Category B | XA10BDX223A001030185553 | NHSA |
| Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | 国药准字H20264418 | See source | Category B | XA10BDX223A001040185553 | NHSA |
| Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | 国药准字H20264418 | See source | Category B | XA10BDX223A001050185553 | NHSA |
| Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | 国药准字H20264418 | See source | Category B | XA10BDX223A001060185553 | NHSA |
| Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | 国药准字H20264418 | See source | Category B | XA10BDX223A001070185553 | NHSA |
| Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | 国药准字H20264418 | See source | Category B | XA10BDX223A001080185553 | NHSA |
| Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | 国药准字H20264418 | See source | Category B | XA10BDX223A001090185553 | NHSA |
| Jilin Chang Bai Shan Pharma Group Co., Ltd. romanized | 国药准字H20244780 | See source | Category B | XA10BDX223A001010103364 | NHSA |
| Tong Hua Dong Bao Pharma Co., Ltd. romanized | 国药准字H20213790 | See source | Category B | XA10BDX223A001010103546 | NHSA |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H20227137 | See source | Category B | XA10BDX223A001010104520 | NHSA |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | 国药准字H20243712 | See source | Category B | XA10BDX223A001010104565 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20223873 | See source | Category B | XA10BDX223A001010104647 | NHSA |
| Zhejiang Ying Ge Lai Pharmaceutical Co., Ltd. romanized | 国药准字H20249536 | See source | Category B | XA10BDX223A001010104749 | NHSA |
| Nanchang Li Jian Pharma Co., Ltd. romanized | 国药准字H20255970 | See source | Category B | XA10BDX223A001010105405 | NHSA |
| Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H20233804 | See source | Category B | XA10BDX223A001010105847 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20243710 | See source | Category B | XA10BDX223A001010106632 | NHSA |
| Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | 国药准字H20203440 | See source | Category B | XA10BDX223A001010106988 | NHSA |
| Shenzhen Han Yu Pharma Co., Ltd. romanized | 国药准字H20233025 | See source | Category B | XA10BDX223A001010179260 | NHSA |
| MSD Pharma(Singapore) Pte. Ltd | H20140775 | See source | Category B | XA10BDX223A001010179533 | NHSA |
| Zhejiang Yong Tai Pharma Co., Ltd. romanized | 国药准字H20253199 | See source | Category B | XA10BDX223A001010181012 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001010183521 | NHSA |
| Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized | 国药准字H20243400 | See source | Category B | XA10BDX223A001010184212 | NHSA |
| Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20244159 | See source | Category B | XA10BDX223A001010184227 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001010184415 | NHSA |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H20227137 | See source | Category B | XA10BDX223A001010204520 | NHSA |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | 国药准字H20243712 | See source | Category B | XA10BDX223A001010204565 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20223873 | See source | Category B | XA10BDX223A001010204647 | NHSA |
| Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H20233804 | See source | Category B | XA10BDX223A001010205847 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20243710 | See source | Category B | XA10BDX223A001010206632 | NHSA |
| Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | 国药准字H20203440 | See source | Category B | XA10BDX223A001010206988 | NHSA |
| Shenzhen Han Yu Pharma Co., Ltd. romanized | 国药准字H20233025 | See source | Category B | XA10BDX223A001010279260 | NHSA |
| MSD Pharma(Singapore) Pte. Ltd | H20140775 | See source | Category B | XA10BDX223A001010279533 | NHSA |
| Zhejiang Yong Tai Pharma Co., Ltd. romanized | 国药准字H20253199 | See source | Category B | XA10BDX223A001010281012 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001010283521 | NHSA |
| Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized | 国药准字H20243400 | See source | Category B | XA10BDX223A001010284212 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001010284415 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20223873 | See source | Category B | XA10BDX223A001010304647 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20243710 | See source | Category B | XA10BDX223A001010306632 | NHSA |
| Shenzhen Han Yu Pharma Co., Ltd. romanized | 国药准字H20233025 | See source | Category B | XA10BDX223A001010379260 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001010383521 | NHSA |
| Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized | 国药准字H20243400 | See source | Category B | XA10BDX223A001010384212 | NHSA |
| Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20244159 | See source | Category B | XA10BDX223A001010384227 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001010384415 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20223873 | See source | Category B | XA10BDX223A001010404647 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20243710 | See source | Category B | XA10BDX223A001010406632 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001010483521 | NHSA |
| Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20244159 | See source | Category B | XA10BDX223A001010484227 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001010484415 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20243710 | See source | Category B | XA10BDX223A001010506632 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001010583521 | NHSA |
| Zhejiang Yi Ze Da Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20244159 | See source | Category B | XA10BDX223A001010584227 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001010584415 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20243710 | See source | Category B | XA10BDX223A001010606632 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001010683521 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001010684415 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001010783521 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001010784415 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001010883521 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001010884415 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001010983521 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001010984415 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001011083521 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001011084415 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001011183521 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001011184415 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001011283521 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001011284415 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001011383521 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001011384415 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001011483521 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001011484415 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001011583521 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001011584415 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001011683521 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001011684415 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001011783521 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001011784415 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001011883521 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001011884415 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001011983521 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001011984415 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001012083521 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001012084415 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001012183521 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001012184415 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001012283521 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001012284415 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001012383521 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001012384415 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001012483521 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001012484415 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001012583521 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001012584415 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001012683521 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001012684415 | NHSA |
| Zhejiang Nord Pharmaceutical Co., Ltd | 国药准字H20244899 | See source | Category B | XA10BDX223A001012783521 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001012784415 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001012884415 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001012984415 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001013084415 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001013184415 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001013284415 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001013384415 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001013484415 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001013584415 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001013684415 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001013784415 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20243568 | See source | Category B | XA10BDX223A001013884415 | 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.
Loaded records: 5 filings and 5 distinct first applicants.
Generic 5
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Duo Duo Pharma Co., Ltd. romanized | CYHS2503626 | Generic | 2025/10/11 | Not stated by source | CDE |
| Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | CYHS2201824 | Generic | 2022/10/25 | Not stated by source | CDE |
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | CYHS2601859 | Generic | 2026/08/03 | Not stated by source | CDE |
| Jiangxi Xing Lin Bai Ma Pharma Co., Ltd. romanized | CYHS2601246 | Generic | 2026/06/02 | Not stated by source | CDE |
| Jiangxi Shimei Pharmaceutical Co., Ltd | CYHS2501932 | Generic | 2025/05/30 | Not stated by source | CDE |
Loaded records: 2 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Shandong Pu Rui Man Pharma Co., Ltd. romanized | CYHS2601859 | Generic | 2026/08/03 | Not stated by source | CDE |
| Jiangxi Xing Lin Bai Ma Pharma Co., Ltd. romanized | CYHS2601246 | Generic | 2026/06/02 | Not stated by source | CDE |
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 |
|---|---|---|---|---|---|---|
| No matching records were found in the currently loaded source data; coverage dates are listed below. | ||||||
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.
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.
JYHB2600395
Fact date: 2026/10/23 · Site observation date: 2026/10/23
Accepted: 2026/07/17
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗JYHB2600394
Fact date: 2026/10/23 · Site observation date: 2026/10/23
Accepted: 2026/07/17
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗JYHB2600395
Fact date: 2026/10/21 · Publication date: 2026/10/23 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 167 ↗JYHB2600394
Fact date: 2026/10/21 · Publication date: 2026/10/23 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 166 ↗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.
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.
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.
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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