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达格列净二甲双胍缓释片(IV)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 1 applicationNotification delivery: 1 application
Current coverage may be incomplete
Which companies are listed, and at what stages?
Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.
Company names, approval identifiers and strengths are retained as recorded in the Chinese sources. Category labels include the original wording for verification.
Catalogue holders3View records ↓
Under-review filings8View records ↓
This year’s generic filers3View records ↓
NHSA approval numbers2View records ↓
API companies with A status0View records ↓
Chemical-drug catalogue
Loaded records: 3 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 3 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 |
|---|---|---|---|---|---|---|
| 河南立诺制药有限公司 | 天津汉瑞药业有限公司 | 国药准字H20263034 | 2026/01/05 | 每片含达格列净10mg（按C21H25ClO6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H20254140 | 2025/05/13 | 每片含达格列净10mg（按C21H25ClO6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 |
| 四川美大康药业股份有限公司 | 四川美大康药业股份有限公司 | 国药准字H20266264 | 2026/10/13 | 每片含达格列净10mg（按C21H25ClO6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 |
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: 2 distinct approval numbers and 2 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 浙江华海药业股份有限公司 | 国药准字H20254140 | 每片含达格列净10mg(按C21H25ClO6计)和盐酸二甲双胍500mg | Not stated by source | XA10BDD369A010010104647 | NHSA |
| AstraZeneca AB | 国药准字HJ20230079 | 达格列净10mg( 以C₂₁H₂₅ClO₆ 计)和盐酸二甲双 | Not stated by source | XA10BDD369A010010179096 | 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: 8 filings and 8 distinct first applicants.
Generic 7 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 新石阳光药业（河北）有限公司 | CYHS2600906 | Generic | 2026/04/21 | Not stated by source | CDE |
| 天方药业有限公司 | CYHS2600994 | Generic | 2026/04/28 | Not stated by source | CDE |
| 九洲生物医药（台州）有限公司 | CYHS2600073 | Generic | 2026/01/08 | Not stated by source | CDE |
| 山东诺禾康药业有限公司 | CYHS2503413 | Generic | 2025/09/16 | Not stated by source | CDE |
| 上海现代制药股份有限公司 | CYHS2502843 | Generic | 2025/08/06 | Not stated by source | CDE |
| 北京赛而生物药业有限公司 | CYHS2504133 | Generic | 2025/12/02 | Not stated by source | CDE |
| 石药集团欧意药业有限公司 | CYHS2503107 | Generic | 2025/08/23 | Not stated by source | CDE |
| 合肥合源药业有限公司 | CYHB2601997 | Supplement | 2026/11/04 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 3 filings and 3 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 | CYHS2600906 | Generic | 2026/04/21 | Not stated by source | CDE |
| 天方药业有限公司 | CYHS2600994 | Generic | 2026/04/28 | Not stated by source | CDE |
| 九洲生物医药（台州）有限公司 | CYHS2600073 | Generic | 2026/01/08 | 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) | 2026/11/08 | 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, 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.
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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）
JYHS2500023
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 31 ↗ -
2026/11/04Accepted
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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