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盐酸二甲双胍缓释片(IV)
Companies, stages and changes, with each record available on this page.
No changes recorded by this site in the last 90 days
Complete CDE snapshot: 2026/11/10 07:27
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 holders1View records ↓
Under-review filings3View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers1View records ↓
API companies with A status40View records ↓
Chemical-drug catalogue
Loaded records: 1 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 1 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 |
|---|---|---|---|---|---|---|
| 广州玻思韬控释药业有限公司 | 广州玻思韬控释药业有限公司 | 国药准字H20233457 | 2023/04/17 | 1.0g | 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: 1 distinct approval numbers and 1 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 武汉久安药物研究院有限公司 | 国药准字H20233457 | 1.0g | Category B (乙) | XA10BAE096A010010181227 | NHSA |
| 武汉久安药物研究院有限公司 | 国药准字H20233457 | 1.0g | Category B (乙) | XA10BAE096A010010281227 | NHSA |
| 武汉久安药物研究院有限公司 | 国药准字H20233457 | 1.0g | Category B (乙) | XA10BAE096A010010381227 | NHSA |
| 武汉久安药物研究院有限公司 | 国药准字H20233457 | 1.0g | Category B (乙) | XA10BAE096A010010481227 | 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: 3 filings and 3 distinct first applicants.
Supplement 1 · Generic 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 武汉久安药物研究院有限公司;广州玻思韬控释药业有限公司 | CYHB2600866 | Supplement | 2026/05/07 | Not stated by source | CDE |
| 北京双鹭药业股份有限公司 | CYHS2601267 | Generic | 2026/06/04 | Not stated by source | CDE |
| 德州博诚制药有限公司 | CYHS2601148 | Generic | 2026/05/14 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
API registrations
Non-component matches: 40 companies with A status and 3 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 |
|---|---|---|---|---|---|---|
| 盐酸二甲双胍 | 河南优凯制药有限公司 | Y20250000327 | A | Exact ingredient | 2026/11/04 | CDE |
| 盐酸二甲双胍 | 山东鲁瑞药业有限公司 | Y20250000352 | A | Exact ingredient | 2026/09/21 | CDE |
| 盐酸二甲双胍 | 白云山东泰商丘药业有限公司 | Y20240000805 | A | Exact ingredient | 2026/03/15 | CDE |
| 盐酸二甲双胍 | 莱阳司邦得制药有限公司 | Y20240000473 | A | Exact ingredient | 2025/12/12 | CDE |
| 盐酸二甲双胍 | 吉林凯莱英医药化学有限公司 | Y20240000113 | A | Exact ingredient | 2025/11/10 | CDE |
| 盐酸二甲双胍 | Sohan Healthcare Private Limited | Y20220000895 | A | Exact ingredient | 2026/01/22 | CDE |
| 盐酸二甲双胍 | 河北天成药业股份有限公司 | Y20220001156 | A | Exact ingredient | 2025/02/20 | CDE |
| 盐酸二甲双胍 | 江苏德源药业股份有限公司 | Y20220000686 | A | Exact ingredient | 2025/05/27 | CDE |
| 盐酸二甲双胍 | 华东医药（西安）博华制药有限公司 | Y20220000357 | A | Exact ingredient | 2024/05/13 | CDE |
| 盐酸二甲双胍 | IOL Chemicals and Pharmaceuticals Ltd. | Y20210000679 | A | Exact ingredient | 2024/02/18 | CDE |
| 盐酸二甲双胍 | SMRUTHI ORGANICS LIMITED | Y20200001011 | I | Exact ingredient | 2021/05/25 | CDE |
| 盐酸二甲双胍 | 天方药业有限公司 | Y20200001441 | A | Exact ingredient | 2022/08/31 | CDE |
| 盐酸二甲双胍 | 山东寿光博康制药有限公司 | Y20200001309 | A | Exact ingredient | 2024/06/14 | CDE |
| 盐酸二甲双胍 | HARMAN FINOCHEM LIMITED | Y20200001045 | A | Exact ingredient | 2024/11/21 | CDE |
| 盐酸二甲双胍 | Harman Finochem Limited | Y20200000973 | A | Exact ingredient | 2023/03/24 | CDE |
| 盐酸二甲双胍 | 宁夏恒康科技有限公司 | Y20200001044 | A | Exact ingredient | 2024/01/17 | CDE |
| 盐酸二甲双胍 | Abhilasha Pharma Pvt. Ltd. | Y20190021198 | A | Exact ingredient | 2022/10/31 | CDE |
| 盐酸二甲双胍 | Exemed Pharmaceuticals | Y20200000139 | A | Exact ingredient | 2022/11/07 | CDE |
| 盐酸二甲双胍 | Laurus Labs Limited | Y20200000513 | A | Exact ingredient | 2024/08/09 | CDE |
| 盐酸二甲双胍 | Apitoria Pharma Private Limited | Y20200000422 | A | Exact ingredient | 2025/04/10 | CDE |
| 盐酸二甲双胍 | Wanbury Limited | Y20200000314 | A | Exact ingredient | 2022/10/14 | CDE |
| 盐酸二甲双胍 | MERCK SANTE SAS | Y20190009925 | A | Exact ingredient | — | CDE |
| 盐酸二甲双胍 | 寿光富康制药有限公司 | Y20190009726 | A | Exact ingredient | 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 | Exact ingredient | 2025/06/14 | CDE |
| 盐酸二甲双胍 | 山东科源制药股份有限公司 | Y20190009395 | A | Exact ingredient | 2026/07/07 | CDE |
| 盐酸二甲双胍 | Aarti Drugs Ltd. | Y20190009174 | A | Exact ingredient | 2025/08/06 | CDE |
| 盐酸二甲双胍 | 曲阜圣仁制药有限公司 | Y20190008915 | A | Exact ingredient | 2022/10/28 | CDE |
| 盐酸二甲双胍 | 石家庄市普力制药有限公司 | Y20190008451 | A | Exact ingredient | 2025/01/03 | CDE |
| 盐酸二甲双胍 | 江苏汉斯通药业有限公司 | Y20190007133 | A | Exact ingredient | — | CDE |
| 盐酸二甲双胍 | 淮南舜隆制药有限公司 | Y20190006466 | A | Exact ingredient | 2026/06/23 | CDE |
| 盐酸二甲双胍 | 华润双鹤药业股份有限公司 | Y20190006308 | A | Exact ingredient | 2023/03/24 | CDE |
| 盐酸二甲双胍 | 江苏同禾药业有限公司 | Y20190006246 | A | Exact ingredient | — | CDE |
| 盐酸二甲双胍 | 吉林金恒制药股份有限公司 | Y20190006023 | A | Exact ingredient | 2026/01/27 | CDE |
| 盐酸二甲双胍 | 好医生药业集团有限公司 | Y20190005982 | A | Exact ingredient | — | CDE |
| 盐酸二甲双胍 | 吉林省四合药业科技有限公司 | Y20190005512 | A | Exact ingredient | 2025/01/04 | CDE |
| 盐酸二甲双胍 | null | Y20190004800 | A | Exact ingredient | 2024/06/06 | CDE |
| 盐酸二甲双胍 | 富祥（大连）制药有限公司 | Y20190004140 | A | Exact ingredient | — | CDE |
| 盐酸二甲双胍 | 丹东医创药业有限责任公司 | Y20190003827 | A | Exact ingredient | 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 | Exact ingredient | 2023/03/24 | CDE |
| 盐酸二甲双胍 | null | Y20190002602 | A | Exact ingredient | 2024/10/24 | CDE |
| 盐酸二甲双胍 | FARMHISPANIA, S.A. | Y20190000147 | I | Exact ingredient | 2019/09/27 | CDE |
| 盐酸二甲双胍 | Vistin Pharma AS | Y20190000108 | A | Exact ingredient | 2026/09/24 | CDE |
| 盐酸二甲双胍 | MERCK SANTE S.A.S. | Y20180001691 | A | Exact ingredient | 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 | Exact ingredient | 2018/10/22 | CDE |
| 盐酸二甲双胍 | 山东科源制药股份有限公司 | Y20180000016 | A | Exact ingredient | 2023/08/14 | CDE |
| 盐酸二甲双胍 | 寿光富康制药有限公司 | Y20180000778 | A | Exact ingredient | — | CDE |
| 盐酸二甲双胍 | MERCK SANTE SAS | Y20170002070 | A | Exact ingredient | 2024/11/17 | 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.
- No matching records were found in the currently loaded source data; coverage dates are listed below.
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/10 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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