Monthly
US$200
Billed every month
Sitagliptin and Metformin Hydrochloride Extended-release Tablets(西格列汀二甲双胍缓释片)
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationAccepted: 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.
Company names, approval identifiers and strengths are retained as recorded in the Chinese sources. Category labels include the original wording for verification.
Catalogue holders19View records ↓
Under-review filings14View records ↓
This year’s generic filers5View records ↓
NHSA approval numbers24View records ↓
API companies with A status0View records ↓
Chemical-drug catalogue
Loaded records: 19 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 19 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 |
|---|---|---|---|---|---|---|
| 河北天成药业股份有限公司 | 河北天成药业股份有限公司 | 国药准字H20265737 | 2026/08/25 | 磷酸西格列汀50mg（以C16H15F6N5O计）和盐酸二甲双胍500mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 南京正大天晴制药有限公司 | 南京正大天晴制药有限公司 | 国药准字H20269199 | 2026/08/11 | 每片含磷酸西格列汀50mg（按C16H15F6N5O计）和盐酸二甲双胍1000mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 长春海悦药业股份有限公司 | 长春海悦药业股份有限公司 | 国药准字H20265445 | 2026/08/04 | 磷酸西格列汀100mg（按C16H15F6N5O计）和盐酸二甲双胍1000mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 江苏谦仁生物科技有限公司 | 江苏谦仁生物科技有限公司 | 国药准字H20264802 | 2026/06/17 | 磷酸西格列汀100mg（按C16H15F6N5O计）和盐酸二甲双胍1000mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 浙江九洲生物医药有限公司 | 广州玻思韬控释药业有限公司 | 国药准字H20264762 | 2026/06/10 | 每片含磷酸西格列汀100mg（以C16H15F6N5O计）和盐酸二甲双胍1000mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 浙江九洲生物医药有限公司 | 广州玻思韬控释药业有限公司 | 国药准字H20264764 | 2026/06/10 | 每片含磷酸西格列汀50mg（以C16H15F6N5O计）和盐酸二甲双胍500mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 常州制药厂有限公司 | 常州制药厂有限公司 | 国药准字H20263256 | 2026/01/27 | 每片含磷酸西格列汀50mg（按C16H15F6N5O计）和盐酸二甲双胍500mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 浙江赛默制药有限公司 | 浙江赛默制药有限公司 | 国药准字H20255792 | 2025/12/17 | 磷酸西格列汀50mg（以C16H15F6N5O计）和盐酸二甲双胍500mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 广东东阳光药业股份有限公司 | 宜昌东阳光长江药业股份有限公司 | 国药准字H20256238 | 2025/12/16 | 磷酸西格列汀100mg（以C16H15F6N5O计）和盐酸二甲双胍1000mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 浙江赛默制药有限公司 | 浙江赛默制药有限公司 | 国药准字H20255793 | 2025/10/28 | 磷酸西格列汀100mg（以C16H15F6N5O计）和盐酸二甲双胍1000mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 平光制药股份有限公司 | 平光制药股份有限公司 | 国药准字H20255807 | 2025/10/28 | 西格列汀100mg（以C16H15F6N5O计）与盐酸二甲双胍1000mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 北京亚宝生物药业有限公司 | 北京亚宝生物药业有限公司 | 国药准字H20255599 | 2025/09/30 | 磷酸西格列汀100mg（按C16H15F6N5O计）与盐酸二甲双胍1000mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 复星万邦（江苏）医药集团有限公司 | 复星万邦（江苏）医药集团有限公司 | 国药准字H20255635 | 2025/09/30 | 磷酸西格列汀100mg（以C16H15F6N5O计）和盐酸二甲双胍1000mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 江苏宣泰药业有限公司 | 江苏宣泰药业有限公司 | 国药准字H20258134 | 2025/09/22 | 每片含磷酸西格列汀50mg（以C16H15F6N5O计）和盐酸二甲双胍500mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 越洋医药开发（广州）有限公司 | 以岭万洲国际制药有限公司 | 国药准字H20255428 | 2025/09/09 | 每片含磷酸西格列汀50mg(（按C16H15F6N5O计）)和盐酸二甲双胍500mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 南通联亚药业股份有限公司 | 南通联亚药业股份有限公司 | 国药准字H20255056 | 2025/07/30 | 每片含磷酸西格列汀50mg（按C16H15F6N5O计）和盐酸二甲双胍500mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 浙江昂利康制药股份有限公司 | 浙江昂利康制药股份有限公司 | 国药准字H20255065 | 2025/07/30 | 磷酸西格列汀50mg（以C16H15F6N5O计）和盐酸二甲双胍500mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 南通联亚药业股份有限公司 | 南通联亚药业股份有限公司 | 国药准字H20255058 | 2025/07/30 | 每片含磷酸西格列汀100mg（按C16H15F6N5O计）和盐酸二甲双胍1000mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 江苏德源药业股份有限公司 | 江苏德源药业股份有限公司 | 国药准字H20254043 | 2025/04/30 | 磷酸西格列汀100mg (以C16H15F6N5O计)和盐酸二甲双胍1000mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 齐鲁制药（海南）有限公司 | 齐鲁制药（海南）有限公司 | 国药准字H20253718 | 2025/03/25 | 每片含磷酸西格列汀50mg（按C16H15F6N5O计）和盐酸二甲双胍500mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 宁波美舒医药科技有限公司 | 宁波美诺华天康药业有限公司 | 国药准字H20253646 | 2025/03/18 | 每片含磷酸西格列汀50mg（以C16H15F6N5O计）与盐酸二甲双胍500mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 正大天晴药业集团股份有限公司 | 正大天晴药业集团股份有限公司 | 国药准字H20233556 | 2023/05/19 | 磷酸西格列汀50mg（以C<sub>16</sub>H<sub>15</sub>F<sub>6</sub>N<sub>5</sub>O计）和盐酸二甲双胍500mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | CDE |
| 南京正大天晴制药有限公司 | 南京正大天晴制药有限公司 | 国药准字H20213961 | 2021/12/31 | 每片含磷酸西格列汀100mg（按C16H15F6N5O计）和盐酸二甲双胍1000mg | Generic approved under the new chemical-drug registration classification (按化学药品新注册分类批准的仿制药) | 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: 24 distinct approval numbers and 20 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 常州制药厂有限公司 | 国药准字H20263256 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计)和盐酸二甲双胍500mg | Category B (乙) | XA10BDX252A010010101397 | NHSA |
| 河北天成药业股份有限公司 | 国药准字H20265737 | 磷酸西格列汀50mg(以 C₁₆H₁₅F₆N₅O计)和盐酸二甲双胍 500mg | Category B (乙) | XA10BDX252A010010102662 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010010103307 | NHSA |
| 浙江九洲生物医药有限公司 | 国药准字H20264762 | 每片含磷酸西格列汀100mg(以 C₁₆H₁₅F₆N₅O计)和盐酸二甲双胍 1000mg | Category B (乙) | XA10BDX252A010010184212 | NHSA |
| 江苏谦仁生物科技有限公司 | 国药准字H20264802 | 磷酸西格列汀100mg(按C₁₆H₁₅F₆N₅O计计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010010185576 | NHSA |
| 河北天成药业股份有限公司 | 国药准字H20265737 | 磷酸西格列汀50mg(以 C₁₆H₁₅F₆N₅O计)和盐酸二甲双胍 500mg | Category B (乙) | XA10BDX252A010010202662 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010010203307 | NHSA |
| 河北天成药业股份有限公司 | 国药准字H20265737 | 磷酸西格列汀50mg(以 C₁₆H₁₅F₆N₅O计)和盐酸二甲双胍 500mg | Category B (乙) | XA10BDX252A010010302662 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010010303307 | NHSA |
| 河北天成药业股份有限公司 | 国药准字H20265737 | 磷酸西格列汀50mg(以 C₁₆H₁₅F₆N₅O计)和盐酸二甲双胍 500mg | Category B (乙) | XA10BDX252A010010402662 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010010403307 | NHSA |
| 河北天成药业股份有限公司 | 国药准字H20265737 | 磷酸西格列汀50mg(以 C₁₆H₁₅F₆N₅O计)和盐酸二甲双胍 500mg | Category B (乙) | XA10BDX252A010010502662 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010010503307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010010603307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010010703307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010010803307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010010903307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010011003307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010011103307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010011203307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010011303307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010011403307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010011503307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010011603307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010011703307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010011803307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010011903307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010012003307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010012103307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010012203307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010012303307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010012403307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010012503307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010012603307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010012703307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010012803307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010012903307 | NHSA |
| 长春海悦药业股份有限公司 | 国药准字H20265445 | 磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010013003307 | NHSA |
| 南京正大天晴制药有限公司 | 国药准字H20269199 | 每片含磷酸西格列汀50mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010020101606 | NHSA |
| 浙江九洲生物医药有限公司 | 国药准字H20264764 | 每片含磷酸西格列汀50mg(以 C₁₆H₁₅F₆N₅O计)和盐酸二甲双胍 500mg | Category B (乙) | XA10BDX252A010020184212 | NHSA |
| 南京正大天晴制药有限公司 | 国药准字H20269199 | 每片含磷酸西格列汀50mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010020201606 | NHSA |
| 南京正大天晴制药有限公司 | 国药准字H20269199 | 每片含磷酸西格列汀50mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010020301606 | NHSA |
| 南京正大天晴制药有限公司 | 国药准字H20269199 | 每片含磷酸西格列汀50mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010020401606 | NHSA |
| 南京正大天晴制药有限公司 | 国药准字H20269199 | 每片含磷酸西格列汀50mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010020501606 | NHSA |
| 南京正大天晴制药有限公司 | 国药准字H20269199 | 每片含磷酸西格列汀50mg(按C16H15F6N5O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010020601606 | NHSA |
| 正大天晴药业集团股份有限公司 | 国药准字H20233556 | 磷酸西格列汀50mg(以C₁₆H₁₅F₆N₅O计)和盐酸二甲 | Category B (乙) | XA10BDX252A010010101523 | NHSA |
| 南京正大天晴制药有限公司 | 国药准字H20213961 | 每片含磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸 | Category B (乙) | XA10BDX252A010010101606 | NHSA |
| 复星万邦(江苏)医药集团有限公司 | 国药准字H20255635 | 磷酸西格列汀100mg(以C₁₆H₁₅F₆N₅O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010010101729 | NHSA |
| 浙江昂利康制药股份有限公司 | 国药准字H20255065 | 磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计)与盐酸二甲双胍500mg | Category B (乙) | XA10BDX252A010010104606 | NHSA |
| 齐鲁制药(海南)有限公司 | 国药准字H20253718 | 每片含磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计)和盐酸二甲双胍500mg | Category B (乙) | XA10BDX252A010010105847 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20254043 | 每片含磷酸西格列汀100mg(以C16H15F6N5O 计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010010106632 | NHSA |
| 宜昌东阳光长江药业股份有限公司 | 国药准字H20256238 | 磷酸西格列汀100mg(按 C₁₆H₁₅F₆N₅O计)和盐酸二甲双胍 1000mg | Category B (乙) | XA10BDX252A010010106988 | NHSA |
| 北京亚宝生物药业有限公司 | 国药准字H20255599 | 磷酸西格列汀100mg(按C₁₆H₁₅F₆N₅O计)与盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010010109542 | NHSA |
| 平光制药股份有限公司 | 国药准字H20255807 | 磷酸西格列汀100mg(按C₁₆H₁₅F₆N₅O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010010180610 | NHSA |
| 江苏宣泰药业有限公司 | 国药准字H20258134 | 每片含磷酸西格列汀50mg(以C₁₆H₁₅F₆N₅O计)和盐酸二甲双胍500mg | Category B (乙) | XA10BDX252A010010181522 | NHSA |
| 广州誉东健康制药有限公司 | 国药准字H20243149 | 每片含磷酸西格列汀50mg(以C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX252A010010182990 | NHSA |
| 江苏悦兴药业有限公司 | 国药准字H20255428 | 每片含磷酸西格列汀50mg(按 C₁₆H₁₅F₆N₅O计)和盐酸二甲双胍 500mg | Category B (乙) | XA10BDX252A010010183482 | NHSA |
| 浙江赛默制药有限公司 | 国药准字H20255792 | 磷酸西格列汀50mg(按 C₁₆H₁₅F₆N₅O计)和盐酸二甲双胍 500mg | Category B (乙) | XA10BDX252A010010183549 | NHSA |
| 南通联亚药业股份有限公司 | 国药准字H20255056 | 每片含磷酸西格列汀50mg(按 C₁₆H₁₅F₆N₅O计)和盐酸二甲双胍 500mg | Category B (乙) | XA10BDX252A010010183802 | NHSA |
| 宁波美舒药业有限公司 | 国药准字H20253646 | 每片含磷酸西格列汀50mg(以 C₁₆H₁₅F₆N₅O计)和盐酸二甲双胍 500mg | Category B (乙) | XA10BDX252A010010184223 | NHSA |
| 南京正大天晴制药有限公司 | 国药准字H20213961 | 每片含磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸 | Category B (乙) | XA10BDX252A010010201606 | NHSA |
| 浙江昂利康制药股份有限公司 | 国药准字H20255065 | 磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计)与盐酸二甲双胍500mg | Category B (乙) | XA10BDX252A010010204606 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20254043 | 每片含磷酸西格列汀100mg(以C16H15F6N5O 计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010010206632 | NHSA |
| 平光制药股份有限公司 | 国药准字H20255807 | 磷酸西格列汀100mg(按C₁₆H₁₅F₆N₅O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010010280610 | NHSA |
| 广州誉东健康制药有限公司 | 国药准字H20243149 | 每片含磷酸西格列汀50mg(以C₁₆H₁₅F₆N₅O计) | Category B (乙) | XA10BDX252A010010282990 | NHSA |
| 南京正大天晴制药有限公司 | 国药准字H20213961 | 每片含磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸 | Category B (乙) | XA10BDX252A010010301606 | NHSA |
| 浙江昂利康制药股份有限公司 | 国药准字H20255065 | 磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计)与盐酸二甲双胍500mg | Category B (乙) | XA10BDX252A010010304606 | NHSA |
| 南京正大天晴制药有限公司 | 国药准字H20213961 | 每片含磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸 | Category B (乙) | XA10BDX252A010010401606 | NHSA |
| 浙江昂利康制药股份有限公司 | 国药准字H20255065 | 磷酸西格列汀50mg(按C₁₆H₁₅F₆N₅O计)与盐酸二甲双胍500mg | Category B (乙) | XA10BDX252A010010404606 | NHSA |
| 南京正大天晴制药有限公司 | 国药准字H20213961 | 每片含磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸 | Category B (乙) | XA10BDX252A010010501606 | NHSA |
| 南京正大天晴制药有限公司 | 国药准字H20213961 | 每片含磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸 | Category B (乙) | XA10BDX252A010010601606 | NHSA |
| 南京正大天晴制药有限公司 | 国药准字H20213961 | 每片含磷酸西格列汀100mg(按C16H15F6N5O计)和盐酸 | Category B (乙) | XA10BDX252A010010701606 | NHSA |
| 浙江赛默制药有限公司 | 国药准字H20255793 | 磷酸西格列汀100mg(按 C₁₆H₁₅F₆N₅O计)和盐酸二甲双胍1000mg | Category B (乙) | XA10BDX252A010020183549 | NHSA |
| 南通联亚药业股份有限公司 | 国药准字H20255058 | 每片含磷酸西格列汀100mg(按 C₁₆H₁₅F₆N₅O计)和盐酸二甲双胍 1000mg | Category B (乙) | XA10BDX252A010020183802 | 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: 14 filings and 10 distinct first applicants.
Supplement 1 · Generic 13
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏悦兴药业有限公司;以岭万洲国际制药有限公司 | CYHB2601535 | Supplement | 2026/08/11 | Not stated by source | CDE |
| 山东诺禾康药业有限公司 | CYHS2602251 | Generic | 2026/09/09 | Not stated by source | CDE |
| 浙江和泽医药科技股份有限公司;宁波双成药业有限公司 | CYHS2601053 | Generic | 2026/05/09 | Not stated by source | CDE |
| 石药集团欧意药业有限公司 | CYHS2601057 | Generic | 2026/05/08 | Not stated by source | CDE |
| 杭州和泽坤元药业有限公司;九洲生物医药（台州）有限公司 | CYHS2600923 | Generic | 2026/04/22 | Not stated by source | CDE |
| 深圳市瑞华制药技术有限公司;华益泰康药业股份有限公司 | CYHS2600882 | Generic | 2026/04/17 | Not stated by source | CDE |
| 深圳市瑞华制药技术有限公司;华益泰康药业股份有限公司 | CYHS2600881 | Generic | 2026/04/17 | Not stated by source | CDE |
| 华中药业股份有限公司 | CYHS2504418 | Generic | 2025/12/26 | Not stated by source | CDE |
| 河南中杰药业有限公司 | CYHS2503846 | Generic | 2025/10/31 | Not stated by source | CDE |
| 河南中杰药业有限公司 | CYHS2503845 | Generic | 2025/10/31 | Not stated by source | CDE |
| 保定天浩制药有限公司;杨凌步长制药有限公司 | CYHS2502158 | Generic | 2025/06/17 | Not stated by source | CDE |
| 寿光富康制药有限公司 | CYHS2501999 | Generic | 2025/06/06 | Not stated by source | CDE |
| 石药集团欧意药业有限公司 | CYHS2501354 | Generic | 2025/04/08 | Not stated by source | CDE |
| 石药集团欧意药业有限公司 | CYHS2501353 | Generic | 2025/04/08 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 6 filings and 5 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 山东诺禾康药业有限公司 | CYHS2602251 | Generic | 2026/09/09 | Not stated by source | CDE |
| 浙江和泽医药科技股份有限公司;宁波双成药业有限公司 | CYHS2601053 | Generic | 2026/05/09 | Not stated by source | CDE |
| 石药集团欧意药业有限公司 | CYHS2601057 | Generic | 2026/05/08 | Not stated by source | CDE |
| 杭州和泽坤元药业有限公司;九洲生物医药（台州）有限公司 | CYHS2600923 | Generic | 2026/04/22 | Not stated by source | CDE |
| 深圳市瑞华制药技术有限公司;华益泰康药业股份有限公司 | CYHS2600882 | Generic | 2026/04/17 | Not stated by source | CDE |
| 深圳市瑞华制药技术有限公司;华益泰康药业股份有限公司 | CYHS2600881 | Generic | 2026/04/17 | 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 |
|---|---|---|---|---|---|---|
| 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.
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: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
-
2026/11/03Marketing application approved
南京易亨制药有限公司
CYHS2500350 · 国药准字H20266437
Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06
The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.
View source · Table row 19 ↗ -
2026/09/09Accepted
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/10 07:27
- Chemical-drug catalogue
- Last successful update: 2026/11/10 07:23
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: 2026/11/10 07:25
- 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: 2026/11/10 18:31
First index-page publication dates: 2026-10-26 to 2026-11-10; 0 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/10 08:10 · 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: 3/30; discovered pending details: 20. 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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