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; 1 in the quality-and-efficacy consistency-evaluation category, and 0 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 |
|---|---|---|---|---|---|---|
| 南京海辰药业股份有限公司 | 南京海辰药业股份有限公司 | 国药准字H20247263 | 2024/11/01 | 150mg | 通过质量和疗效一致性评价的药品 | CDE |
| 南京海辰药业股份有限公司 | 南京海辰药业股份有限公司 | 国药准字H20203669 | 2023/11/29 | 50mg | 通过质量和疗效一致性评价的药品 | 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.
NHSA drug codes
Loaded records: 2 distinct approval numbers and 1 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 南京海辰药业股份有限公司 | 国药准字H20203669 | 50mg | 乙 | XC07ABL385B001010201563 | NHSA |
| 南京海辰药业股份有限公司 | 国药准字H20203669 | 50mg | 乙 | XC07ABL385B001010301563 | NHSA |
| 南京海辰药业股份有限公司 | 国药准字H20247263 | 150mg | 乙 | XC07ABL385B001020101563 | 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: 19 filings and 19 distinct first applicants.
Generic 18 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 南京易亨制药有限公司 | CYHS2601435 | Generic | 2026/06/17 | Not stated by source | CDE |
| 苏州天马医药集团天吉生物制药有限公司 | CYHS2602046 | Generic | 2026/08/18 | Not stated by source | CDE |
| 海南海灵化学制药有限公司 | CYHS2602574 | Generic | 2026/10/19 | Not stated by source | CDE |
| 河北一品制药股份有限公司 | CYHS2602201 | Generic | 2026/09/03 | Not stated by source | CDE |
| 天津天士力之骄药业有限公司 | CYHS2602049 | Generic | 2026/08/18 | Not stated by source | CDE |
| 海南灵康制药有限公司 | CYHS2601949 | Generic | 2026/08/10 | Not stated by source | CDE |
| 广东隆赋药业股份有限公司 | CYHS2601863 | Generic | 2026/08/03 | Not stated by source | CDE |
| 中山万汉制药有限公司;广东星昊药业有限公司 | CYHS2601775 | Generic | 2026/07/24 | Not stated by source | CDE |
| 康普药业股份有限公司 | CYHS2601557 | Generic | 2026/07/01 | Not stated by source | CDE |
| 福安药业集团湖北人民制药有限公司 | CYHS2601533 | Generic | 2026/06/30 | Not stated by source | CDE |
| 华北制药股份有限公司 | CYHS2601423 | Generic | 2026/06/16 | Not stated by source | CDE |
| 成都苑东生物制药股份有限公司 | CYHS2601421 | Generic | 2026/06/16 | Not stated by source | CDE |
| 哈尔滨三联药业股份有限公司 | CYHS2601362 | Generic | 2026/06/10 | Not stated by source | CDE |
| 朗天药业（湖北）有限公司 | CYHS2601314 | Generic | 2026/06/05 | Not stated by source | CDE |
| 四川奥邦古得药业有限公司;四川宏明博思药业有限公司 | CYHS2601276 | Generic | 2026/06/04 | Not stated by source | CDE |
| 宜昌人福药业有限责任公司 | CYHS2601236 | Generic | 2026/06/01 | Not stated by source | CDE |
| 杭州沐源生物医药科技股份有限公司;成都通德药业有限公司 | CYHS2601195 | Generic | 2026/05/26 | Not stated by source | CDE |
| 海南合瑞制药股份有限公司 | CYHS2502080 | Generic | 2025/06/12 | Not stated by source | CDE |
| 南京海辰药业股份有限公司 | CYHB2601936 | Supplement | 2026/10/22 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 17 filings and 17 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 南京易亨制药有限公司 | CYHS2601435 | Generic | 2026/06/17 | Not stated by source | CDE |
| 苏州天马医药集团天吉生物制药有限公司 | CYHS2602046 | Generic | 2026/08/18 | Not stated by source | CDE |
| 海南海灵化学制药有限公司 | CYHS2602574 | Generic | 2026/10/19 | Not stated by source | CDE |
| 河北一品制药股份有限公司 | CYHS2602201 | Generic | 2026/09/03 | Not stated by source | CDE |
| 天津天士力之骄药业有限公司 | CYHS2602049 | Generic | 2026/08/18 | Not stated by source | CDE |
| 海南灵康制药有限公司 | CYHS2601949 | Generic | 2026/08/10 | Not stated by source | CDE |
| 广东隆赋药业股份有限公司 | CYHS2601863 | Generic | 2026/08/03 | Not stated by source | CDE |
| 中山万汉制药有限公司;广东星昊药业有限公司 | CYHS2601775 | Generic | 2026/07/24 | Not stated by source | CDE |
| 康普药业股份有限公司 | CYHS2601557 | Generic | 2026/07/01 | Not stated by source | CDE |
| 福安药业集团湖北人民制药有限公司 | CYHS2601533 | Generic | 2026/06/30 | Not stated by source | CDE |
| 华北制药股份有限公司 | CYHS2601423 | Generic | 2026/06/16 | Not stated by source | CDE |
| 成都苑东生物制药股份有限公司 | CYHS2601421 | Generic | 2026/06/16 | Not stated by source | CDE |
| 哈尔滨三联药业股份有限公司 | CYHS2601362 | Generic | 2026/06/10 | Not stated by source | CDE |
| 朗天药业（湖北）有限公司 | CYHS2601314 | Generic | 2026/06/05 | Not stated by source | CDE |
| 四川奥邦古得药业有限公司;四川宏明博思药业有限公司 | CYHS2601276 | Generic | 2026/06/04 | Not stated by source | CDE |
| 宜昌人福药业有限责任公司 | CYHS2601236 | Generic | 2026/06/01 | Not stated by source | CDE |
| 杭州沐源生物医药科技股份有限公司;成都通德药业有限公司 | CYHS2601195 | Generic | 2026/05/26 | Not stated by source | CDE |
API registrations
Non-component matches: 8 companies with A status and 10 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 |
|---|---|---|---|---|---|---|
| 盐酸兰地洛尔 | 山东益康药业股份有限公司 | Y20260000838 | I | Exact ingredient | 2026/10/10 | CDE |
| 盐酸兰地洛尔 | 江苏九旭药业有限公司 | Y20260000518 | I | Exact ingredient | 2026/09/14 | CDE |
| 盐酸兰地洛尔 | 河北一品制药股份有限公司 | Y20260000528 | I | Exact ingredient | 2026/06/30 | CDE |
| 盐酸兰地洛尔 | 浙江国邦药业有限公司 | Y20260000436 | I | Exact ingredient | 2026/06/04 | CDE |
| 盐酸兰地洛尔 | 汉瑞药业（荆门）有限公司 | Y20250001297 | I | Exact ingredient | 2025/12/19 | CDE |
| 盐酸兰地洛尔 | 宜昌天睿生物医药有限责任公司 | Y20250001011 | I | Exact ingredient | 2025/10/15 | CDE |
| 盐酸兰地洛尔 | 广东隆赋药业股份有限公司 | Y20250000886 | I | Exact ingredient | 2025/08/25 | CDE |
| 盐酸兰地洛尔 | 康普药业股份有限公司 | Y20250000569 | A | Exact ingredient | 2026/10/21 | CDE |
| 盐酸兰地洛尔 | Mehta API Pvt. Ltd. | Y20250000431 | I | Exact ingredient | 2025/07/11 | CDE |
| 盐酸兰地洛尔 | 湖南复瑞生物医药技术有限责任公司 | Y20250000441 | A | Exact ingredient | 2026/10/29 | CDE |
| 盐酸兰地洛尔 | 成都奥邦药业有限公司 | Y20240000701 | A | Exact ingredient | 2026/02/25 | CDE |
| 盐酸兰地洛尔 | 中瑞（内蒙古）药业股份有限公司 | Y20240000948 | I | Exact ingredient | 2025/08/06 | CDE |
| 盐酸兰地洛尔 | 中山万汉制药有限公司 | Y20240000889 | A | Exact ingredient | 2026/07/21 | CDE |
| 盐酸兰地洛尔 | 兰西哈三联制药有限公司 | Y20230001330 | A | Exact ingredient | 2025/07/22 | CDE |
| 盐酸兰地洛尔 | 四川青木制药有限公司 | Y20230001029 | A | Exact ingredient | 2025/11/21 | CDE |
| 盐酸兰地洛尔 | 海南合瑞制药股份有限公司 | Y20230000570 | A | Exact ingredient | 2025/02/14 | CDE |
| 盐酸兰地洛尔 | PROCOS S.P.A | Y20220000150 | I | Exact ingredient | 2024/07/23 | CDE |
| 盐酸兰地洛尔 | 南京海辰药业股份有限公司 | Y20170001289 | A | Exact ingredient | 2025/05/21 | 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.
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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2026/10/22Accepted
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2026/10/19Accepted
-
2026/09/03Accepted
-
2026/08/18Accepted
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2026/08/18Accepted
苏州天马医药集团天吉生物制药有限公司
CYHS2602046
Fact date: 2026/08/18 · Site observation date: 2026/10/21
View source ↗ -
2026/08/10Accepted
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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