Which companies are listed, and at what stages?
Each source is counted separately. Expand a list to inspect companies, identifiers, dates and sources.
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 |
|---|---|---|---|---|---|---|
| 山东朗诺制药有限公司 | 山东朗诺制药有限公司 | 国药准字H20265153 | 2026/07/14 | 5mg（按C22H25ClO7计） | 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 |
|---|---|---|---|---|---|
| 山东朗诺制药有限公司 | 国药准字H20265153 | 5mg(按C₂₂H₂₅ClO₇计) | 乙 | XA10BKA338A001010110323 | NHSA |
| 山东朗诺制药有限公司 | 国药准字H20265153 | 5mg(按C₂₂H₂₅ClO₇计) | 乙 | XA10BKA338A001010210323 | NHSA |
| Merck Sharp & Dohme B.V. | 国药准字HJ20200023 | 5mg(以艾托格列净计) | 乙 | XA10BKA338A001010580716 | NHSA |
| Merck Sharp & Dohme B.V. | 国药准字HJ20200023 | 5mg(以艾托格列净计) | 乙 | XA10BKA338A001010680716 | 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: 11 filings and 11 distinct first applicants.
Generic 11
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏德源药业股份有限公司 | CYHS2601520 | Generic | 2026/06/29 | Not stated by source | CDE |
| 南京正科医药股份有限公司 | CYHS2602375 | Generic | 2026/09/21 | Not stated by source | CDE |
| 兰西哈三联制药有限公司 | CYHS2602432 | Generic | 2026/09/29 | Not stated by source | CDE |
| 安徽宏业药业有限公司 | CYHS2602363 | Generic | 2026/09/21 | Not stated by source | CDE |
| 安徽泰恩康制药有限公司 | CYHS2602350 | Generic | 2026/09/20 | Not stated by source | CDE |
| 西安万隆制药股份有限公司 | CYHS2602091 | Generic | 2026/08/24 | Not stated by source | CDE |
| 浙江普洛康裕制药有限公司 | CYHS2601783 | Generic | 2026/07/24 | Not stated by source | CDE |
| 山东诺明康药物研究院有限公司;山东诺禾康药业有限公司 | CYHS2601491 | Generic | 2026/06/24 | Not stated by source | CDE |
| 宁波美诺华天康药业有限公司 | CYHS2600572 | Generic | 2026/02/27 | Not stated by source | CDE |
| 江西泰吉立生物制药有限公司 | CYHS2600131 | Generic | 2026/01/10 | Not stated by source | CDE |
| 华润赛科药业有限责任公司 | CYHS2600041 | Generic | 2026/01/06 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 11 filings and 11 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏德源药业股份有限公司 | CYHS2601520 | Generic | 2026/06/29 | Not stated by source | CDE |
| 南京正科医药股份有限公司 | CYHS2602375 | Generic | 2026/09/21 | Not stated by source | CDE |
| 兰西哈三联制药有限公司 | CYHS2602432 | Generic | 2026/09/29 | Not stated by source | CDE |
| 安徽宏业药业有限公司 | CYHS2602363 | Generic | 2026/09/21 | Not stated by source | CDE |
| 安徽泰恩康制药有限公司 | CYHS2602350 | Generic | 2026/09/20 | Not stated by source | CDE |
| 西安万隆制药股份有限公司 | CYHS2602091 | Generic | 2026/08/24 | Not stated by source | CDE |
| 浙江普洛康裕制药有限公司 | CYHS2601783 | Generic | 2026/07/24 | Not stated by source | CDE |
| 山东诺明康药物研究院有限公司;山东诺禾康药业有限公司 | CYHS2601491 | Generic | 2026/06/24 | Not stated by source | CDE |
| 宁波美诺华天康药业有限公司 | CYHS2600572 | Generic | 2026/02/27 | Not stated by source | CDE |
| 江西泰吉立生物制药有限公司 | CYHS2600131 | Generic | 2026/01/10 | Not stated by source | CDE |
| 华润赛科药业有限责任公司 | CYHS2600041 | Generic | 2026/01/06 | Not stated by source | CDE |
API registrations
Non-component matches: 2 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 |
|---|---|---|---|---|---|---|
| 艾托格列净 | 华润双鹤药业股份有限公司 | Y20250000083 | A | Exact ingredient | 2026/07/31 | CDE |
| 艾托格列净 | 山东朗诺制药有限公司 | Y20230001296 | A | Exact ingredient | 2025/08/22 | 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.
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2026/09/29Accepted
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2026/09/21Accepted
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2026/09/21Accepted
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2026/09/20Accepted
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2026/08/24Accepted
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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