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Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 3 applicationsSupplement delivery: 3 applications
Current coverage may be incomplete
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.
Loaded records: 2 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 |
|---|---|---|---|---|---|---|
| 齐鲁制药有限公司 | 齐鲁制药有限公司 | 国药准字H20253310 | 2025/01/24 | 2.3mg(按14H19BCl2N2O4计) | 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 |
| 齐鲁制药有限公司 | 齐鲁制药有限公司 | 国药准字H20253308 | 2025/01/24 | 4mg(按C14H19BCl2N2O4计) | 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 |
| 齐鲁制药有限公司 | 齐鲁制药有限公司 | 国药准字H20253309 | 2025/01/24 | 3mg(按C14H19BCl2N2O4计) | 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 |
| Takeda Pharma A/S | Haupt Pharma Amareg GmbH | H20180012 | 2018/04/12 | 2.3mg | Imported originator drug (进口原研药品) | CDE |
| Takeda Pharma A/S | Haupt Pharma Amareg GmbH | H20180011 | 2018/04/12 | 3mg | Imported originator drug (进口原研药品) | CDE |
| Takeda Pharma A/S | Haupt Pharma Amareg GmbH | H20180010 | 2018/04/12 | 4mg | Imported originator drug (进口原研药品) | 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.
Loaded records: 3 distinct approval numbers and 1 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Takeda Pharma A/S | 国药准字HJ20180012 | 2.3mg(按C₁₄H₁₉BCl₂N₂O₄计 ) | Category B (乙) | XL01XGY306E001010179422 | NHSA |
| Takeda Pharma A/S | 国药准字HJ20180011 | 3mg(按C₁₄H₁₉BCl₂N₂O₄计 ) | Category B (乙) | XL01XGY306E001020179422 | NHSA |
| Takeda Pharma A/S | 国药准字HJ20180010 | 4mg(按C₁₄H₁₉BCl₂N₂O₄计 ) | Category B (乙) | XL01XGY306E001030179422 | 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.
Loaded records: 7 filings and 3 distinct first applicants.
Generic 7
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 合肥亿帆生物制药有限公司;东曜药业有限公司 | CYHS2602459 | Generic | 2026/10/09 | Not stated by source | CDE |
| 合肥亿帆生物制药有限公司;东曜药业有限公司 | CYHS2602458 | Generic | 2026/10/09 | Not stated by source | CDE |
| 合肥亿帆生物制药有限公司;东曜药业有限公司 | CYHS2602457 | Generic | 2026/10/09 | Not stated by source | CDE |
| 正大天晴药业集团股份有限公司 | CYHS2601883 | Generic | 2026/08/03 | Not stated by source | CDE |
| 正大天晴药业集团股份有限公司 | CYHS2601882 | Generic | 2026/08/03 | Not stated by source | CDE |
| 正大天晴药业集团股份有限公司 | CYHS2601881 | Generic | 2026/08/03 | Not stated by source | CDE |
| 华东医药(西安)博华制药有限公司;杭州中美华东制药有限公司 | CYHS2504526 | Generic | 2026/01/04 | Not stated by source | CDE |
Loaded records: 7 filings and 3 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 合肥亿帆生物制药有限公司;东曜药业有限公司 | CYHS2602459 | Generic | 2026/10/09 | Not stated by source | CDE |
| 合肥亿帆生物制药有限公司;东曜药业有限公司 | CYHS2602458 | Generic | 2026/10/09 | Not stated by source | CDE |
| 合肥亿帆生物制药有限公司;东曜药业有限公司 | CYHS2602457 | Generic | 2026/10/09 | Not stated by source | CDE |
| 正大天晴药业集团股份有限公司 | CYHS2601883 | Generic | 2026/08/03 | Not stated by source | CDE |
| 正大天晴药业集团股份有限公司 | CYHS2601882 | Generic | 2026/08/03 | Not stated by source | CDE |
| 正大天晴药业集团股份有限公司 | CYHS2601881 | Generic | 2026/08/03 | Not stated by source | CDE |
| 华东医药(西安)博华制药有限公司;杭州中美华东制药有限公司 | CYHS2504526 | Generic | 2026/01/04 | Not stated by source | CDE |
Non-component matches: 6 companies with A status and 6 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 |
|---|---|---|---|---|---|---|
| 枸橼酸伊沙佐米 | 深圳万乐药业有限公司 | Y20250001384 | I | Exact ingredient | 2025/12/31 | CDE |
| 枸橼酸伊沙佐米 | 重庆凯林制药有限公司 | Y20250000999 | I | Exact ingredient | 2025/12/19 | CDE |
| 枸橼酸伊沙佐米 | 连云港润众制药有限公司 | Y20250001105 | I | Exact ingredient | 2025/10/23 | CDE |
| 枸橼酸伊沙佐米 | 华东医药(西安)博华制药有限公司 | Y20250000693 | I | Exact ingredient | 2025/08/11 | CDE |
| 枸橼酸伊沙佐米 | 四川青木制药有限公司 | Y20250000549 | A | Exact ingredient | 2026/11/05 | CDE |
| 枸橼酸伊沙佐米 | 宿州亿帆药业有限公司 | Y20250000670 | I | Exact ingredient | 2025/07/08 | CDE |
| 枸橼酸伊沙佐米 | 四川汇宇制药股份有限公司 | Y20250000534 | A | Exact ingredient | 2026/10/21 | CDE |
| 枸橼酸伊沙佐米 | 江苏天士力帝益药业有限公司 | Y20250000103 | A | Exact ingredient | 2026/06/30 | CDE |
| 枸橼酸伊沙佐米 | 山东新时代药业有限公司 | Y20240001475 | A | Exact ingredient | 2026/07/21 | CDE |
| 枸橼酸伊沙佐米 | 重庆迈德凯医药有限公司 | Y20240000575 | I | Exact ingredient | 2025/08/29 | CDE |
| 枸橼酸伊沙佐米 | 齐鲁制药有限公司 | Y20230000721 | A | Exact ingredient | 2026/05/22 | CDE |
| 枸橼酸伊沙佐米 | 四川科伦药业股份有限公司 | Y20230000110 | A | Exact ingredient | 2024/11/21 | 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.
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.
JYHB2600410
Fact date: 2026/10/20 · Publication date: 2026/10/21 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 22 ↗JYHB2600409
Fact date: 2026/10/20 · Publication date: 2026/10/21 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 21 ↗JYHB2600408
Fact date: 2026/10/20 · Publication date: 2026/10/21 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 20 ↗CYHS2602459
Fact date: 2026/10/09 · Site observation date: 2026/10/22
View source ↗CYHS2602458
Fact date: 2026/10/09 · Site observation date: 2026/10/22
View source ↗CYHS2602457
Fact date: 2026/10/09 · Site observation date: 2026/10/22
View source ↗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.
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.
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.
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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