达格列净二甲双胍缓释片(I)
Companies, stages and changes, with each record available on this page.
Follow for freeWhich companies are listed, and at what stages?
Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.
Catalogue holders17View records ↓
Under-review filings42View records ↓
This year’s generic filers16View records ↓
NHSA approval numbers17View records ↓
API companies with A status0View records ↓
Chemical-drug catalogue
Loaded records: 17 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 16 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 |
|---|---|---|---|---|---|---|
| 山东鲁抗医药股份有限公司 | 山东鲁抗医药股份有限公司 | 国药准字H20265610 | 2026/08/04 | 每片含达格列净10mg(按C21H25CIO6计)和盐酸二甲双胍1000mg | 按化学药品新注册分类批准的仿制药 | CDE |
| 江苏安必生制药有限公司 | 江苏安必生制药有限公司 | 国药准字H20265558 | 2026/08/04 | 每片含达格列净5mg（按C21H25ClO6计）和盐酸二甲双胍500mg | 按化学药品新注册分类批准的仿制药 | CDE |
| 新乡市常乐制药有限责任公司 | 新乡市常乐制药有限责任公司 | 国药准字H20265176 | 2026/07/14 | 每片含达格列净10mg（按 C21H25ClO6 计）和盐酸二甲双胍1000mg | 按化学药品新注册分类批准的仿制药 | CDE |
| 江苏万高药业股份有限公司 | 江苏万高药业股份有限公司 | 国药准字H20264490 | 2026/05/19 | 每片含达格列净10mg（按C21H25ClO6计）和盐酸二甲双胍1000mg | 按化学药品新注册分类批准的仿制药 | CDE |
| 辰欣药业股份有限公司 | 辰欣药业股份有限公司 | 国药准字H20264126 | 2026/04/21 | 每片含达格列净10mg(按C21H25ClO6计)与盐酸二甲双胍1000mg | 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H20263923 | 2026/04/14 | 每片含达格列净10mg（以C21H25ClO6计）和盐酸二甲双胍1000mg | Not stated by source | 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H20263758 | 2026/03/31 | 每片含达格列净10mg(按C21H25ClO6计)和盐酸二甲双胍1000mg | 按化学药品新注册分类批准的仿制药 | CDE |
| 河南立诺制药有限公司 | 天津汉瑞药业有限公司 | 国药准字H20263035 | 2026/01/05 | 每片含达格列净5mg（按C21H25ClO6计）和盐酸二甲双胍500mg | 按化学药品新注册分类批准的仿制药 | CDE |
| 北京伟林恒昌医药科技有限公司 | 北京京丰制药集团有限公司 | 国药准字H20255287 | 2025/09/02 | 每片含达格列净10mg（以C21H25ClO6计）和盐酸二甲双胍1000mg | 按化学药品新注册分类批准的仿制药 | CDE |
| 浙江华海药业股份有限公司 | 浙江华海药业股份有限公司 | 国药准字H20254137 | 2025/05/13 | 每片含达格列净5mg（按C21H25ClO6计）和盐酸二甲双胍500mg | 按化学药品新注册分类批准的仿制药 | CDE |
| 浙江华海药业股份有限公司 | 浙江华海药业股份有限公司 | 国药准字H20254138 | 2025/05/13 | 每片含达格列净10mg（按C21H25ClO6计）和盐酸二甲双胍1000mg | 按化学药品新注册分类批准的仿制药 | CDE |
| 石家庄四药有限公司 | 石家庄四药有限公司 | 国药准字H20253948 | 2025/04/15 | 每片含达格列净10mg（按C21H25ClO6计）和盐酸二甲双胍1000 mg | 按化学药品新注册分类批准的仿制药 | CDE |
| 南京方生和医药科技有限公司 | 以岭万洲国际制药有限公司 | 国药准字H20253855 | 2025/04/08 | 每片含达格列净10mg（以C21H25ClO6计）和盐酸二甲双胍1000mg | 按化学药品新注册分类批准的仿制药 | CDE |
| 齐鲁制药有限公司 | 齐鲁制药有限公司 | 国药准字H20253377 | 2025/02/11 | 每片含达格列净10mg（按C21H25ClO6计）与盐酸二甲双胍1000mg | 按化学药品新注册分类批准的仿制药 | CDE |
| 北京福元医药股份有限公司 | 北京福元医药股份有限公司 | 国药准字H20253160 | 2025/01/14 | 达格列净10mg（以C21H25ClO6计）和盐酸二甲双胍1000mg | 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H20249466 | 2024/12/01 | 达格列净10mg（以C21H25ClO6计）和盐酸二甲双胍1000mg | 按化学药品新注册分类批准的仿制药 | CDE |
| 上海宣泰医药科技股份有限公司 | 江苏宣泰药业有限公司 | 国药准字H20244866 | 2024/09/10 | 每片含达格列净10mg和盐酸二甲双胍1000mg | 按化学药品新注册分类批准的仿制药 | CDE |
| 南京臣功制药股份有限公司 | 以岭万洲国际制药有限公司 | 国药准字H20256447 | 2025/12/30 | 每片含达格列净10mg（以C21H25ClO6计）和盐酸二甲双胍1000mg | 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: 17 distinct approval numbers and 15 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 优辉药业(北京)有限公司 | 国药准字H20255287 | 每片含达格列净10mg(以C₂₁H₂₅ClO₆计)和盐酸二甲双胍1000mg | 乙 | XA10BDD366A010010183203 | NHSA |
| 江苏安必生制药有限公司 | 国药准字H20265558 | 每片含达格列净5mg(按C₂₁H₂₅ClO₆计)和盐酸二甲双胍500mg | 乙 | XA10BDD366A010010183683 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20253160 | 达格列净10mg(以C₂₁H₂₅ClO₆计)和盐酸二甲双胍1000mg | 乙 | XA10BDD366A010010100177 | NHSA |
| 南京臣功制药股份有限公司 | 国药准字H20256447 | 每片含达格列净10mg(以C₂₁H₂₅ClO₆计)和盐酸二甲双胍1000mg | 乙 | XA10BDD366A010010101556 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20254137 | 每片含达格列净5mg(按C21H25ClO6计)和盐酸二甲双胍500mg | 乙 | XA10BDD366A010010104647 | NHSA |
| 南京方生和医药科技有限公司 | 国药准字H20253855 | 每片含达格列净10mg(按C₂₁H₂₅ClO₆计)和盐酸二甲双胍1000mg | 乙 | XA10BDD366A010010183343 | NHSA |
| 北京福元医药股份有限公司 | 国药准字H20253160 | 达格列净10mg(以C₂₁H₂₅ClO₆计)和盐酸二甲双胍1000mg | 乙 | XA10BDD366A010010200177 | NHSA |
| 南京方生和医药科技有限公司 | 国药准字H20253855 | 每片含达格列净10mg(按C₂₁H₂₅ClO₆计)和盐酸二甲双胍1000mg | 乙 | XA10BDD366A010010283343 | NHSA |
| 南京方生和医药科技有限公司 | 国药准字H20253855 | 每片含达格列净10mg(按C₂₁H₂₅ClO₆计)和盐酸二甲双胍1000mg | 乙 | XA10BDD366A010010383343 | NHSA |
| 浙江华海药业股份有限公司 | 国药准字H20254138 | 每片含达格列净10mg(按C21H25ClO6计)和盐酸二甲双胍1000mg | 乙 | XA10BDD366A010020104647 | NHSA |
| 南京正大天晴制药有限公司 | 国药准字H20249466 | 达格列净10mg(以C₂₁H₂₅ClO₆计)和盐酸二甲双胍1000mg | 乙 | XA10BDD366A010010101606 | NHSA |
| 新乡市常乐制药有限责任公司 | 国药准字H20265176 | 每片含达格列净10mg(按C₂₁H₂₅ClO₆计)和盐酸二甲双胍1000mg | 乙 | XA10BDD366A010010103216 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20264126 | 每片含达格列净10mg(按C₂₁H₂₅ClO₆计)与盐酸二甲双胍1000mg | 乙 | XA10BDD366A010010104127 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20263758 | 每片含达格列净10mg(按 C₂₁H₂₅ClO₆计)和盐酸二甲双胍 1000mg | 乙 | XA10BDD366A010010106632 | NHSA |
| 山东鲁抗医药股份有限公司 | 国药准字H20265610 | 每片含达格列净10mg(按C₂₁H₂₅ClO₆计)和盐酸二甲双胍1000mg | 乙 | XA10BDD366A010010183198 | NHSA |
| 南通联亚药业股份有限公司 | 国药准字H20263923 | 每片含达格列净10mg(以 C₂₁H₂₅ClO₆计)和盐酸二甲双胍 1000mg | 乙 | XA10BDD366A010010183802 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20264126 | 每片含达格列净10mg(按C₂₁H₂₅ClO₆计)与盐酸二甲双胍1000mg | 乙 | XA10BDD366A010010204127 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20263758 | 每片含达格列净10mg(按 C₂₁H₂₅ClO₆计)和盐酸二甲双胍 1000mg | 乙 | XA10BDD366A010010206632 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20264126 | 每片含达格列净10mg(按C₂₁H₂₅ClO₆计)与盐酸二甲双胍1000mg | 乙 | XA10BDD366A010010304127 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20263758 | 每片含达格列净10mg(按 C₂₁H₂₅ClO₆计)和盐酸二甲双胍 1000mg | 乙 | XA10BDD366A010010306632 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20264126 | 每片含达格列净10mg(按C₂₁H₂₅ClO₆计)与盐酸二甲双胍1000mg | 乙 | XA10BDD366A010010404127 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20263758 | 每片含达格列净10mg(按 C₂₁H₂₅ClO₆计)和盐酸二甲双胍 1000mg | 乙 | XA10BDD366A010010406632 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20264126 | 每片含达格列净10mg(按C₂₁H₂₅ClO₆计)与盐酸二甲双胍1000mg | 乙 | XA10BDD366A010010504127 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20263758 | 每片含达格列净10mg(按 C₂₁H₂₅ClO₆计)和盐酸二甲双胍 1000mg | 乙 | XA10BDD366A010010506632 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20264126 | 每片含达格列净10mg(按C₂₁H₂₅ClO₆计)与盐酸二甲双胍1000mg | 乙 | XA10BDD366A010010604127 | NHSA |
| 江苏德源药业股份有限公司 | 国药准字H20263758 | 每片含达格列净10mg(按 C₂₁H₂₅ClO₆计)和盐酸二甲双胍 1000mg | 乙 | XA10BDD366A010010606632 | NHSA |
| 辰欣药业股份有限公司 | 国药准字H20264126 | 每片含达格列净10mg(按C₂₁H₂₅ClO₆计)与盐酸二甲双胍1000mg | 乙 | XA10BDD366A010010704127 | NHSA |
| 石家庄四药有限公司 | 国药准字H20253948 | 每片含达格列净10mg(按C₂₁H₂₅ClO₆计)和盐酸二甲双胍1000mg | 乙 | XA10BDD366A010010102763 | NHSA |
| AstraZeneca AB | 国药准字HJ20230077 | 达格列净5mg( 以C₂₁H₂₅ClO₆ 计)和盐酸二甲双 | 乙 | XA10BDD366A010010179096 | NHSA |
| 江苏宣泰药业有限公司 | 国药准字H20244866 | 达格列净10mg(以C₂₁H₂₅ClO₆ 计)和盐酸二甲双 | 乙 | XA10BDD366A010010183135 | NHSA |
| 江苏宣泰药业有限公司 | 国药准字H20244866 | 达格列净10mg(以C₂₁H₂₅ClO₆ 计)和盐酸二甲双 | 乙 | XA10BDD366A010010283135 | NHSA |
| 江苏宣泰药业有限公司 | 国药准字H20244866 | 达格列净10mg(以C₂₁H₂₅ClO₆ 计)和盐酸二甲双 | 乙 | XA10BDD366A010010383135 | NHSA |
| 江苏宣泰药业有限公司 | 国药准字H20244866 | 达格列净10mg(以C₂₁H₂₅ClO₆ 计)和盐酸二甲双 | 乙 | XA10BDD366A010010483135 | NHSA |
| AstraZeneca AB | 国药准字HJ20230080 | 达格列净10mg( 以C₂₁H₂₅ClO₆ 计)和盐酸二甲双 | 乙 | XA10BDD366A010020179096 | NHSA |
| AstraZeneca AB | 国药准字HJ20230080 | 达格列净10mg( 以C₂₁H₂₅ClO₆ 计)和盐酸二甲双 | 乙 | XA10BDD366A010020279096 | NHSA |
| AstraZeneca AB | 国药准字HJ20230080 | 达格列净10mg( 以C₂₁H₂₅ClO₆ 计)和盐酸二甲双 | 乙 | XA10BDD366A010020379096 | 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: 42 filings and 37 distinct first applicants.
Generic 38 · Supplement 2 · Import 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 沂南力诺制药有限责任公司 | CYHS2504241 | Generic | 2025/12/10 | Not stated by source | CDE |
| 青岛黄海制药有限责任公司 | CYHS2503344 | Generic | 2025/09/10 | Not stated by source | CDE |
| 新石阳光药业（河北）有限公司 | CYHS2600907 | Generic | 2026/04/21 | Not stated by source | CDE |
| 新石阳光药业（河北）有限公司 | CYHS2600904 | Generic | 2026/04/21 | Not stated by source | CDE |
| 山西德元堂药业有限公司 | CYHS2600556 | Generic | 2026/02/27 | Not stated by source | CDE |
| 山西德元堂药业有限公司 | CYHS2600555 | Generic | 2026/02/27 | Not stated by source | CDE |
| 安徽省先锋制药有限公司 | CYHS2504057 | Generic | 2025/11/25 | Not stated by source | CDE |
| 天方药业有限公司 | CYHS2600996 | Generic | 2026/04/28 | Not stated by source | CDE |
| 天方药业有限公司 | CYHS2600993 | Generic | 2026/04/28 | Not stated by source | CDE |
| 浙江普洛康裕制药有限公司 | CYHS2502838 | Generic | 2025/08/06 | Not stated by source | CDE |
| 云鹏医药集团有限公司;安徽佳和药业有限公司 | CYHB2601513 | Supplement | 2026/08/10 | Not stated by source | CDE |
| 中美华世通生物医药科技（武汉）股份有限公司;湖北华世通生物医药科技有限公司 | CYHS2600846 | Generic | 2026/04/13 | Not stated by source | CDE |
| 九洲生物医药（台州）有限公司 | CYHS2600072 | Generic | 2026/01/08 | Not stated by source | CDE |
| 九洲生物医药（台州）有限公司 | CYHS2600071 | Generic | 2026/01/08 | Not stated by source | CDE |
| 寿光富康制药有限公司 | CYHS2600023 | Generic | 2026/01/05 | Not stated by source | CDE |
| 江苏天士力帝益药业有限公司 | CYHS2503405 | Generic | 2025/09/16 | Not stated by source | CDE |
| 江苏亚邦爱普森药业有限公司 | CYHS2503603 | Generic | 2025/10/09 | Not stated by source | CDE |
| 北京赛而生物药业有限公司 | CYHS2504130 | Generic | 2025/12/02 | Not stated by source | CDE |
| 合肥立方制药股份有限公司 | CYHS2504022 | Generic | 2025/11/21 | Not stated by source | CDE |
| 陕西君可力医药科技有限公司;石家庄市普力制药有限公司 | CYHS2503192 | Generic | 2025/08/30 | Not stated by source | CDE |
| 上海现代制药股份有限公司 | CYHS2502842 | Generic | 2025/08/06 | Not stated by source | CDE |
| 河南立诺制药有限公司;天津汉瑞药业有限公司 | CYHS2502715 | Generic | 2025/07/28 | Not stated by source | CDE |
| 天津力生制药股份有限公司 | CYHS2502142 | Generic | 2025/06/16 | Not stated by source | CDE |
| M/s Cipla Ltd.;Cipla (China) Pharmaceutical Co. Ltd | JYHS2500020 | Import | 2025/04/25 | Not stated by source | CDE |
| 合肥合源药业有限公司 | CYHB2601998 | Supplement | 2026/11/04 | Not stated by source | CDE |
| 南京易亨制药有限公司 | CYHS2602532 | Generic | 2026/10/14 | Not stated by source | CDE |
| 山东仁和制药有限公司 | CYHS2602471 | Generic | 2026/10/10 | Not stated by source | CDE |
| MSN Laboratories Private Limited | JYHS2600021 | Import | 2026/09/23 | Not stated by source | CDE |
| 浙江诺得药业有限公司 | CYHS2602366 | Generic | 2026/09/21 | Not stated by source | CDE |
| 山东诚创蓝海医药科技有限公司;烟台东诚大洋制药有限公司 | CYHS2601960 | Generic | 2026/08/11 | Not stated by source | CDE |
| 陕西旭昂生物药业有限公司;广州玻思韬控释药业有限公司 | CYHS2601952 | Generic | 2026/08/10 | Not stated by source | CDE |
| 国大（吉林）制药集团有限公司;重庆博腾药业有限公司 | CYHS2601046 | Generic | 2026/05/08 | Not stated by source | CDE |
| 安徽佳和药业有限公司 | CYHS2600977 | Generic | 2026/04/28 | Not stated by source | CDE |
| 山西宝泰药业有限责任公司 | CYHS2600941 | Generic | 2026/04/24 | Not stated by source | CDE |
| 烟台鲁银药业有限公司 | CYHS2600682 | Generic | 2026/03/19 | Not stated by source | CDE |
| 浙江赛默制药有限公司 | CYHS2600554 | Generic | 2026/02/27 | Not stated by source | CDE |
| 安徽金太阳生化药业有限公司 | CYHS2503836 | Generic | 2025/10/31 | Not stated by source | CDE |
| 石药集团欧意药业有限公司 | CYHS2503104 | Generic | 2025/08/23 | Not stated by source | CDE |
| 石药集团欧意药业有限公司 | CYHS2503103 | Generic | 2025/08/23 | Not stated by source | CDE |
| 重庆博腾药业有限公司 | CYHS2502907 | Generic | 2025/08/11 | Not stated by source | CDE |
| 广州大光制药有限公司;重庆博腾药业有限公司 | CYHS2502205 | Generic | 2025/06/19 | Not stated by source | CDE |
| 北京四环科宝制药股份有限公司 | CYHS2501602 | Generic | 2025/04/29 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 20 filings and 16 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 新石阳光药业（河北）有限公司 | CYHS2600907 | Generic | 2026/04/21 | Not stated by source | CDE |
| 新石阳光药业（河北）有限公司 | CYHS2600904 | Generic | 2026/04/21 | Not stated by source | CDE |
| 山西德元堂药业有限公司 | CYHS2600556 | Generic | 2026/02/27 | Not stated by source | CDE |
| 山西德元堂药业有限公司 | CYHS2600555 | Generic | 2026/02/27 | Not stated by source | CDE |
| 天方药业有限公司 | CYHS2600996 | Generic | 2026/04/28 | Not stated by source | CDE |
| 天方药业有限公司 | CYHS2600993 | Generic | 2026/04/28 | Not stated by source | CDE |
| 中美华世通生物医药科技（武汉）股份有限公司;湖北华世通生物医药科技有限公司 | CYHS2600846 | Generic | 2026/04/13 | Not stated by source | CDE |
| 九洲生物医药（台州）有限公司 | CYHS2600072 | Generic | 2026/01/08 | Not stated by source | CDE |
| 九洲生物医药（台州）有限公司 | CYHS2600071 | Generic | 2026/01/08 | Not stated by source | CDE |
| 寿光富康制药有限公司 | CYHS2600023 | Generic | 2026/01/05 | Not stated by source | CDE |
| 南京易亨制药有限公司 | CYHS2602532 | Generic | 2026/10/14 | Not stated by source | CDE |
| 山东仁和制药有限公司 | CYHS2602471 | Generic | 2026/10/10 | Not stated by source | CDE |
| 浙江诺得药业有限公司 | CYHS2602366 | Generic | 2026/09/21 | Not stated by source | CDE |
| 山东诚创蓝海医药科技有限公司;烟台东诚大洋制药有限公司 | CYHS2601960 | Generic | 2026/08/11 | Not stated by source | CDE |
| 陕西旭昂生物药业有限公司;广州玻思韬控释药业有限公司 | CYHS2601952 | Generic | 2026/08/10 | Not stated by source | CDE |
| 国大（吉林）制药集团有限公司;重庆博腾药业有限公司 | CYHS2601046 | Generic | 2026/05/08 | Not stated by source | CDE |
| 安徽佳和药业有限公司 | CYHS2600977 | Generic | 2026/04/28 | Not stated by source | CDE |
| 山西宝泰药业有限责任公司 | CYHS2600941 | Generic | 2026/04/24 | Not stated by source | CDE |
| 烟台鲁银药业有限公司 | CYHS2600682 | Generic | 2026/03/19 | Not stated by source | CDE |
| 浙江赛默制药有限公司 | CYHS2600554 | Generic | 2026/02/27 | Not stated by source | CDE |
API registrations
Non-component matches: 0 companies with A status and 0 I-status records. Component matches are listed separately and excluded from these counts.
| Name | Company / applicant | Registration number | Status | Name match | Source update date | View source |
|---|---|---|---|---|---|---|
| 达格列净 | 天方药业有限公司 | Y20260000662 | I | Component match (excluded from headline counts) | 2026/08/17 | CDE |
| 达格列净 | 江苏阿尔法集团福瑞药业（宿迁）有限公司 | Y20260000249 | I | Component match (excluded from headline counts) | 2026/04/10 | CDE |
| 达格列净 | 湖南千金湘江药业股份有限公司 | Y20260000255 | I | Component match (excluded from headline counts) | 2026/04/09 | CDE |
| 达格列净 | 湖南先施制药有限公司 | Y20250001499 | I | Component match (excluded from headline counts) | 2026/01/13 | CDE |
| 达格列净 | 武穴宏源药业有限公司 | Y20250001044 | I | Component match (excluded from headline counts) | 2025/12/09 | CDE |
| 达格列净 | 长春海悦药业股份有限公司 | Y20250000937 | I | Component match (excluded from headline counts) | 2025/09/04 | CDE |
| 达格列净 | 浙江江北南海药业有限公司 | Y20250000379 | A | Component match (excluded from headline counts) | 2026/10/16 | CDE |
| 盐酸二甲双胍 | 河南优凯制药有限公司 | Y20250000327 | A | Component match (excluded from headline counts) | 2026/11/04 | CDE |
| 盐酸二甲双胍 | 山东鲁瑞药业有限公司 | Y20250000352 | A | Component match (excluded from headline counts) | 2026/09/21 | CDE |
| 达格列净 | 重庆凯林制药有限公司 | Y20240001191 | A | Component match (excluded from headline counts) | 2026/05/12 | CDE |
| 达格列净 | 北京赛而生物药业有限公司 | Y20240001369 | A | Component match (excluded from headline counts) | 2026/04/21 | CDE |
| 达格列净 | 迪嘉药业集团股份有限公司 | Y20240001043 | A | Component match (excluded from headline counts) | 2026/07/20 | CDE |
| 达格列净 | Honour Lab Limited Unit Iii | Y20240000587 | A | Component match (excluded from headline counts) | 2026/10/05 | CDE |
| 达格列净 | 山东诚汇双达药业有限公司 | Y20240000916 | A | Component match (excluded from headline counts) | 2026/10/17 | CDE |
| 盐酸二甲双胍 | 白云山东泰商丘药业有限公司 | Y20240000805 | A | Component match (excluded from headline counts) | 2026/03/15 | CDE |
| 达格列净 | 浙江宏元药业股份有限公司 | Y20240000845 | A | Component match (excluded from headline counts) | 2026/05/20 | CDE |
| 达格列净 | 万洋衡水制药有限公司 | Y20240000873 | A | Component match (excluded from headline counts) | 2026/01/05 | CDE |
| 达格列净 | 浙江奥翔药业股份有限公司 | Y20240000835 | A | Component match (excluded from headline counts) | 2025/12/29 | CDE |
| 达格列净 | 湖北天舒药业有限公司 | Y20240000848 | A | Component match (excluded from headline counts) | 2026/10/27 | CDE |
| 达格列净 | 浙江华海药业股份有限公司 | Y20240000545 | A | Component match (excluded from headline counts) | 2026/09/05 | CDE |
| 盐酸二甲双胍 | 莱阳司邦得制药有限公司 | Y20240000473 | A | Component match (excluded from headline counts) | 2025/12/12 | CDE |
| 达格列净 | 天地恒一制药股份有限公司 | Y20240000242 | A | Component match (excluded from headline counts) | 2025/09/04 | CDE |
| 达格列净 | 浙江九洲药业股份有限公司 | Y20240000151 | A | Component match (excluded from headline counts) | 2025/10/17 | CDE |
| 盐酸二甲双胍 | 吉林凯莱英医药化学有限公司 | Y20240000113 | A | Component match (excluded from headline counts) | 2025/11/10 | CDE |
| 达格列净 | 苏州正济药业有限公司 | Y20230000874 | A | Component match (excluded from headline counts) | 2026/03/27 | CDE |
| 达格列净 | 北京福元医药股份有限公司 | Y20230000752 | A | Component match (excluded from headline counts) | 2024/12/13 | CDE |
| 达格列净 | 江苏德源药业股份有限公司 | Y20230000695 | A | Component match (excluded from headline counts) | 2025/03/08 | CDE |
| 达格列净 | KRKA, d.d., Novo mesto | Y20230000350 | A | Component match (excluded from headline counts) | 2025/08/06 | CDE |
| 达格列净 | 植恩生物技术股份有限公司 | Y20230000618 | A | Component match (excluded from headline counts) | 2026/06/04 | CDE |
| 达格列净 | 白银京宇新药业有限公司 | Y20230000626 | A | Component match (excluded from headline counts) | 2026/04/03 | CDE |
| 达格列净 | MSN Laboratories Private Limited | Y20230000345 | A | Component match (excluded from headline counts) | 2025/07/28 | CDE |
| 达格列净 | 湖南九典宏阳制药有限公司 | Y20230000318 | A | Component match (excluded from headline counts) | 2026/06/09 | CDE |
| 达格列净 | 潍坊市海欣药业有限公司 | Y20230000410 | A | Component match (excluded from headline counts) | 2024/09/05 | CDE |
| 达格列净 | 汉瑞药业（荆门）有限公司 | Y20230000355 | A | Component match (excluded from headline counts) | 2024/11/12 | CDE |
| 达格列净 | 诚达药业股份有限公司 | Y20230000033 | A | Component match (excluded from headline counts) | 2025/10/27 | CDE |
| 盐酸二甲双胍 | Sohan Healthcare Private Limited | Y20220000895 | A | Component match (excluded from headline counts) | 2026/01/22 | CDE |
| 达格列净 | 浙江天宇药业股份有限公司 | Y20220001121 | A | Component match (excluded from headline counts) | 2025/04/11 | CDE |
| 盐酸二甲双胍 | 河北天成药业股份有限公司 | Y20220001156 | A | Component match (excluded from headline counts) | 2025/02/20 | CDE |
| 达格列净 | Biocon Limited | Y20220000163 | A | Component match (excluded from headline counts) | 2025/09/05 | CDE |
| 达格列净 | 浙江华海药业股份有限公司 | Y20220000893 | A | Component match (excluded from headline counts) | 2025/12/18 | CDE |
| 达格列净 | 宣城美诺华药业有限公司 | Y20220000754 | A | Component match (excluded from headline counts) | 2024/05/30 | CDE |
| 达格列净 | 阜新龙瑞药业有限责任公司 | Y20220000604 | A | Component match (excluded from headline counts) | 2025/05/14 | CDE |
| 达格列净 | 河北国龙制药有限公司 | Y20220000818 | A | Component match (excluded from headline counts) | 2025/12/31 | CDE |
| 达格列净 | 江苏慧聚药业股份有限公司 | Y20220000848 | A | Component match (excluded from headline counts) | 2024/05/31 | CDE |
| 达格列净 | 石药集团欧意药业有限公司 | Y20220000867 | A | Component match (excluded from headline counts) | 2025/10/23 | CDE |
| 达格列净 | MSN Laboratories Private Limited | Y20220000610 | I | Component match (excluded from headline counts) | 2023/11/03 | CDE |
| 盐酸二甲双胍 | 江苏德源药业股份有限公司 | Y20220000686 | A | Component match (excluded from headline counts) | 2025/05/27 | CDE |
| 达格列净 | 石药集团欧意药业有限公司 | Y20220000658 | I | Component match (excluded from headline counts) | 2022/08/22 | CDE |
| 盐酸二甲双胍 | 华东医药（西安）博华制药有限公司 | Y20220000357 | A | Component match (excluded from headline counts) | 2024/05/13 | CDE |
| 达格列净 | Dr.Reddy's Laboratories Ltd. | Y20220000123 | A | Component match (excluded from headline counts) | 2025/01/11 | CDE |
| 达格列净 | 江苏慧聚药业股份有限公司 | Y20220000259 | A | Component match (excluded from headline counts) | 2025/07/02 | CDE |
| 达格列净 | 诚达药业股份有限公司 | Y20220000029 | I | Component match (excluded from headline counts) | 2023/05/22 | CDE |
| 达格列净 | 四川国为制药有限公司 | Y20210000979 | A | Component match (excluded from headline counts) | 2023/06/07 | CDE |
| 达格列净 | 江苏普润生物医药有限公司 | Y20210001011 | A | Component match (excluded from headline counts) | 2024/03/21 | CDE |
| 盐酸二甲双胍 | IOL Chemicals and Pharmaceuticals Ltd. | Y20210000679 | A | Component match (excluded from headline counts) | 2024/02/18 | CDE |
| 达格列净 | AstraZeneca AB | Y20210000736 | A | Component match (excluded from headline counts) | 2026/05/20 | CDE |
| 达格列净 | Morepen Laboratories Ltd | Y20210000321 | I | Component match (excluded from headline counts) | 2021/07/30 | CDE |
| 达格列净 | Honour Lab Limited, Unit-Ⅲ | Y20210000221 | I | Component match (excluded from headline counts) | 2024/02/27 | CDE |
| 达格列净 | 江苏豪森药业集团有限公司 | Y20210000556 | A | Component match (excluded from headline counts) | 2023/06/29 | CDE |
| 达格列净 | AstraZeneca AB | Y20210000271 | A | Component match (excluded from headline counts) | 2026/08/21 | CDE |
| 盐酸二甲双胍 | SMRUTHI ORGANICS LIMITED | Y20200001011 | I | Component match (excluded from headline counts) | 2021/05/25 | CDE |
| 盐酸二甲双胍 | 天方药业有限公司 | Y20200001441 | A | Component match (excluded from headline counts) | 2022/08/31 | CDE |
| 达格列净 | Dr. Reddy's Laboratories Ltd. | Y20210000100 | A | Component match (excluded from headline counts) | 2026/07/16 | CDE |
| 达格列净 | 新乡双鹭药业有限公司 | Y20200001479 | A | Component match (excluded from headline counts) | 2023/05/06 | CDE |
| 盐酸二甲双胍 | 山东寿光博康制药有限公司 | Y20200001309 | A | Component match (excluded from headline counts) | 2024/06/14 | CDE |
| 盐酸二甲双胍 | HARMAN FINOCHEM LIMITED | Y20200001045 | A | Component match (excluded from headline counts) | 2024/11/21 | CDE |
| 盐酸二甲双胍 | Harman Finochem Limited | Y20200000973 | A | Component match (excluded from headline counts) | 2023/03/24 | CDE |
| 达格列净 | ZCL Chemicals Limited | Y20200000919 | I | Component match (excluded from headline counts) | 2023/03/24 | CDE |
| 盐酸二甲双胍 | 宁夏恒康科技有限公司 | Y20200001044 | A | Component match (excluded from headline counts) | 2024/01/17 | CDE |
| 盐酸二甲双胍 | Abhilasha Pharma Pvt. Ltd. | Y20190021198 | A | Component match (excluded from headline counts) | 2022/10/31 | CDE |
| 盐酸二甲双胍 | Exemed Pharmaceuticals | Y20200000139 | A | Component match (excluded from headline counts) | 2022/11/07 | CDE |
| 盐酸二甲双胍 | Laurus Labs Limited | Y20200000513 | A | Component match (excluded from headline counts) | 2024/08/09 | CDE |
| 盐酸二甲双胍 | Apitoria Pharma Private Limited | Y20200000422 | A | Component match (excluded from headline counts) | 2025/04/10 | CDE |
| 达格列净 | Honour Lab Limited, Unit-III | Y20200000244 | A | Component match (excluded from headline counts) | 2024/01/31 | CDE |
| 盐酸二甲双胍 | Wanbury Limited | Y20200000314 | A | Component match (excluded from headline counts) | 2022/10/14 | CDE |
| 达格列净 | 北京福元医药股份有限公司 | Y20200000298 | A | Component match (excluded from headline counts) | 2026/05/15 | CDE |
| 盐酸二甲双胍 | MERCK SANTE SAS | Y20190009925 | A | Component match (excluded from headline counts) | — | CDE |
| 盐酸二甲双胍 | 寿光富康制药有限公司 | Y20190009726 | A | Component match (excluded from headline counts) | 2026/01/24 | CDE |
| 盐酸二甲双胍 | 天津太平洋化学制药有限公司 | Y20190009517 | A | Component match (excluded from headline counts) | 2025/06/14 | CDE |
| 盐酸二甲双胍 | 山东科源制药股份有限公司 | Y20190009395 | A | Component match (excluded from headline counts) | 2026/07/07 | CDE |
| 盐酸二甲双胍 | Aarti Drugs Ltd. | Y20190009174 | A | Component match (excluded from headline counts) | 2025/08/06 | CDE |
| 盐酸二甲双胍 | 曲阜圣仁制药有限公司 | Y20190008915 | A | Component match (excluded from headline counts) | 2022/10/28 | CDE |
| 盐酸二甲双胍 | 石家庄市普力制药有限公司 | Y20190008451 | A | Component match (excluded from headline counts) | 2025/01/03 | CDE |
| 盐酸二甲双胍 | 江苏汉斯通药业有限公司 | Y20190007133 | A | Component match (excluded from headline counts) | — | CDE |
| 盐酸二甲双胍 | 淮南舜隆制药有限公司 | Y20190006466 | A | Component match (excluded from headline counts) | 2026/06/23 | CDE |
| 盐酸二甲双胍 | 华润双鹤药业股份有限公司 | Y20190006308 | A | Component match (excluded from headline counts) | 2023/03/24 | CDE |
| 盐酸二甲双胍 | 江苏同禾药业有限公司 | Y20190006246 | A | Component match (excluded from headline counts) | — | CDE |
| 盐酸二甲双胍 | 吉林金恒制药股份有限公司 | Y20190006023 | A | Component match (excluded from headline counts) | 2026/01/27 | CDE |
| 盐酸二甲双胍 | 好医生药业集团有限公司 | Y20190005982 | A | Component match (excluded from headline counts) | — | CDE |
| 盐酸二甲双胍 | 吉林省四合药业科技有限公司 | Y20190005512 | A | Component match (excluded from headline counts) | 2025/01/04 | CDE |
| 盐酸二甲双胍 | null | Y20190004800 | A | Component match (excluded from headline counts) | 2024/06/06 | CDE |
| 盐酸二甲双胍 | 富祥（大连）制药有限公司 | Y20190004140 | A | Component match (excluded from headline counts) | — | CDE |
| 盐酸二甲双胍 | 丹东医创药业有限责任公司 | Y20190003827 | A | Component match (excluded from headline counts) | 2025/06/07 | CDE |
| 盐酸二甲双胍 | 天津中新药业集团股份有限公司新新制药厂 | Y20190002946 | A | Component match (excluded from headline counts) | 2023/03/24 | CDE |
| 盐酸二甲双胍 | null | Y20190002602 | A | Component match (excluded from headline counts) | 2024/10/24 | CDE |
| 盐酸二甲双胍 | FARMHISPANIA, S.A. | Y20190000147 | I | Component match (excluded from headline counts) | 2019/09/27 | CDE |
| 达格列净 | 山东鲁抗医药股份有限公司 | Y20190000428 | A | Component match (excluded from headline counts) | 2026/07/24 | CDE |
| 盐酸二甲双胍 | Vistin Pharma AS | Y20190000108 | A | Component match (excluded from headline counts) | 2026/09/24 | CDE |
| 盐酸二甲双胍 | MERCK SANTE S.A.S. | Y20180001691 | A | Component match (excluded from headline counts) | 2026/03/20 | CDE |
| 盐酸二甲双胍 | 天津太平洋化学制药有限公司 | Y20180000014 | I | Component match (excluded from headline counts) | 2018/10/22 | CDE |
| 盐酸二甲双胍 | 山东科源制药股份有限公司 | Y20180000016 | A | Component match (excluded from headline counts) | 2023/08/14 | CDE |
| 盐酸二甲双胍 | 寿光富康制药有限公司 | Y20180000778 | A | Component match (excluded from headline counts) | — | CDE |
| 盐酸二甲双胍 | MERCK SANTE SAS | Y20170002070 | A | Component match (excluded from headline counts) | 2024/11/17 | CDE |
| 达格列净 | 安徽森吉制药有限公司 | Y20260000911 | I | Component match (excluded from headline counts) | 2026/11/02 | 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, supplements, notices and review changes are labelled separately.
This source was last successfully updated at 2026/11/04 18:32; current coverage may be incomplete.
-
2026/11/04Notification delivery
M/s Cipla Ltd.（注册代理机构：西普拉（中国）医药有限公司）
JYHS2500021
Fact date: 2026/11/04 (Publication date) · Publication date: 2026/11/04 · Site observation date: 2026/11/04
Notification delivered; the specific outcome remains to be checked.
View source · Table row 30 ↗ -
2026/11/04Accepted
-
2026/10/28No longer listed under review
复星医药（徐州）有限公司
CYHS2501344
Fact date: 2026/10/28 · Site observation date: 2026/10/28
Accepted: 2025/04/09
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/10/20Marketing application approved
合肥合源药业有限公司
CYHS2503027 · 国药准字H20266337
Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03
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. NHSA edition maintained to 2026-10-23; latest successful catalogue check: 2026/11/05 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
View source · Table row 99 ↗ -
2026/10/20Marketing application approved
河北智恒医药科技股份有限公司
CYHS2502673 · 国药准字H20266293
Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03
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. NHSA edition maintained to 2026-10-23; latest successful catalogue check: 2026/11/05 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
View source · Table row 93 ↗ -
2026/10/14Accepted
-
2026/10/10Accepted
-
2026/09/23Accepted
MSN Laboratories Private Limited
JYHS2600021
Fact date: 2026/09/23 · Site observation date: 2026/10/21
View source ↗ -
2026/09/21Accepted
-
2026/08/11Accepted
山东诚创蓝海医药科技有限公司;烟台东诚大洋制药有限公司
CYHS2601960
Fact date: 2026/08/11 · Site observation date: 2026/10/21
View source ↗ -
2026/08/10Accepted
陕西旭昂生物药业有限公司;广州玻思韬控释药业有限公司
CYHS2601952
Fact date: 2026/08/10 · Site observation date: 2026/10/21
View source ↗ -
2026/08/10Accepted
云鹏医药集团有限公司;安徽佳和药业有限公司
CYHB2601513
Fact date: 2026/08/10 · Site observation date: 2026/10/21
View source ↗
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/05 06:45
- Chemical-drug catalogue
- Last successful update: 2026/11/05 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: 2026/11/05 06:40
- 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: 2026/11/04 18:32 · Current coverage may be incomplete
First index-page publication dates: 2026-10-21 to 2026-11-05; 1 pages pending. Covers loaded notices only, not a complete historical approval database.
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 or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.
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