Monthly
US$200
Billed every month
Eldecalcitol Soft Capsules(艾地骨化醇软胶囊)
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 holders14View records ↓
Under-review filings8View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers20View records ↓
API companies with A status11View records ↓
Chemical-drug catalogue
Loaded records: 14 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 14 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 |
|---|---|---|---|---|---|---|
| 北京斯利安药业有限公司 | 北京斯利安药业有限公司 | 国药准字H20264357 | 2026/05/19 | 0.75μg | 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 |
| 山东简道制药有限公司 | 山东简道制药有限公司 | 国药准字H20256105 | 2025/12/03 | 0.5μg | Not stated by source | CDE |
| 山东简道制药有限公司 | 山东简道制药有限公司 | 国药准字H20256106 | 2025/12/03 | 0.75μg | 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 |
| 山东新时代药业有限公司 | 山东新时代药业有限公司 | 国药准字H20255266 | 2025/09/02 | 0.75μg | 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 |
| 广东江正药业有限公司 | 江苏万高药业股份有限公司 | 国药准字H20254209 | 2025/05/20 | 0.75μg | 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 |
| 广东江正药业有限公司 | 江苏万高药业股份有限公司 | 国药准字H20254208 | 2025/05/20 | 0.5μg | Not stated by source | CDE |
| 青岛国信制药有限公司 | 青岛国信制药有限公司 | 国药准字H20253727 | 2025/03/25 | 0.75μg | 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 |
| 青岛国信制药有限公司 | 青岛国信制药有限公司 | 国药准字H20253728 | 2025/03/25 | 0.5μg | 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 |
| 正大天晴药业集团股份有限公司 | 正大天晴药业集团股份有限公司 | 国药准字H20253039 | 2025/01/02 | 0.5μg | 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 |
| 正大天晴药业集团股份有限公司 | 正大天晴药业集团股份有限公司 | 国药准字H20253040 | 2025/01/02 | 0.75μg | 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 |
| 四川科伦药业股份有限公司 | 四川科伦药业股份有限公司 | 国药准字H20244646 | 2024/08/05 | 0.75μg | 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 |
| 郑州泰丰制药有限公司 | 河南泰丰生物科技有限公司 | 国药准字H20244479 | 2024/07/22 | 0.75μg | 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 |
| 郑州泰丰制药有限公司 | 河南泰丰生物科技有限公司 | 国药准字H20244480 | 2024/07/22 | 0.5μg | 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 |
| 人福普克药业（武汉）有限公司 | 人福普克药业（武汉）有限公司 | 国药准字H20243290 | 2024/02/23 | 0.5μg | 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 |
| 人福普克药业（武汉）有限公司 | 人福普克药业（武汉）有限公司 | 国药准字H20243289 | 2024/02/23 | 0.75μg | 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 |
| 南京海融制药有限公司 | 南京海融制药有限公司 | 国药准字H20234466 | 2023/11/07 | 0.75μg | 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 |
| 大连美创药业有限公司 | 大连美创药业有限公司 | 国药准字H20234468 | 2023/11/07 | 0.75μg | 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 |
| 南京海融制药有限公司 | 南京海融制药有限公司 | 国药准字H20234465 | 2023/11/07 | 0.5μg | 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 |
| 温州海鹤药业有限公司 | 温州海鹤药业有限公司 | 国药准字H20233213 | 2023/02/21 | 0.75μg | 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 |
| 四川国为制药有限公司 | 四川国为制药有限公司 | 国药准字H20233063 | 2023/01/19 | 0.75μg | 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 |
| 河南泰丰生物科技有限公司 | 河南泰丰生物科技有限公司 | 国药准字H20247029 | 2022/09/30 | 0.5μg | 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 |
| 河南泰丰生物科技有限公司 | 河南泰丰生物科技有限公司 | 国药准字H20223700 | 2022/09/30 | 0.75μg | 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: 20 distinct approval numbers and 13 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 大连美创药业有限公司 | 国药准字H20234468 | 0.75μg | Category B (乙) | XA11CCA351E002010101121 | NHSA |
| 广东江正药业有限公司 | 国药准字H20254209 | 0.75μg | Category B (乙) | XA11CCA351E002010101503 | NHSA |
| 正大天晴药业集团股份有限公司 | 国药准字H20253039 | 0.5μg | Category B (乙) | XA11CCA351E002010101523 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20244646 | 0.75μg | Category B (乙) | XA11CCA351E002010102180 | NHSA |
| 郑州泰丰制药有限公司 | 国药准字H20223700 | 0.75μg | Category B (乙) | XA11CCA351E002010103013 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20255266 | 0.75µg | Category B (乙) | XA11CCA351E002010104188 | NHSA |
| 温州海鹤药业有限公司 | 国药准字H20233213 | 0.75μg | Category B (乙) | XA11CCA351E002010104586 | NHSA |
| 珠海健福制药有限公司 | 国药准字H20244479 | 0.75μg | Category B (乙) | XA11CCA351E002010107011 | NHSA |
| 人福普克药业(武汉)有限公司 | 国药准字H20243289 | 0.75μg | Category B (乙) | XA11CCA351E002010109981 | NHSA |
| Chugai Pharmaceutical Co., Ltd | 国药准字HJ20200057 | 0.5μg | Category B (乙) | XA11CCA351E002010179189 | NHSA |
| 四川国为制药有限公司 | 国药准字H20233063 | 0.75μg | Category B (乙) | XA11CCA351E002010180937 | NHSA |
| 南京海融制药有限公司 | 国药准字H20234466 | 0.75μg | Category B (乙) | XA11CCA351E002010181812 | NHSA |
| 山东简道制药有限公司 | 国药准字H20256105 | 0.5μg | Category B (乙) | XA11CCA351E002010184386 | NHSA |
| 大连美创药业有限公司 | 国药准字H20234468 | 0.75μg | Category B (乙) | XA11CCA351E002010201121 | NHSA |
| 广东江正药业有限公司 | 国药准字H20254209 | 0.75μg | Category B (乙) | XA11CCA351E002010201503 | NHSA |
| 郑州泰丰制药有限公司 | 国药准字H20223700 | 0.75μg | Category B (乙) | XA11CCA351E002010203013 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20255266 | 0.75µg | Category B (乙) | XA11CCA351E002010204188 | NHSA |
| 温州海鹤药业有限公司 | 国药准字H20233213 | 0.75μg | Category B (乙) | XA11CCA351E002010204586 | NHSA |
| 珠海健福制药有限公司 | 国药准字H20244479 | 0.75μg | Category B (乙) | XA11CCA351E002010207011 | NHSA |
| 人福普克药业(武汉)有限公司 | 国药准字H20243289 | 0.75μg | Category B (乙) | XA11CCA351E002010209981 | NHSA |
| 四川国为制药有限公司 | 国药准字H20233063 | 0.75μg | Category B (乙) | XA11CCA351E002010280937 | NHSA |
| 南京海融制药有限公司 | 国药准字H20234466 | 0.75μg | Category B (乙) | XA11CCA351E002010281812 | NHSA |
| 山东简道制药有限公司 | 国药准字H20256105 | 0.5μg | Category B (乙) | XA11CCA351E002010284386 | NHSA |
| 大连美创药业有限公司 | 国药准字H20234468 | 0.75μg | Category B (乙) | XA11CCA351E002010301121 | NHSA |
| 广东江正药业有限公司 | 国药准字H20254209 | 0.75μg | Category B (乙) | XA11CCA351E002010301503 | NHSA |
| 郑州泰丰制药有限公司 | 国药准字H20223700 | 0.75μg | Category B (乙) | XA11CCA351E002010303013 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20255266 | 0.75µg | Category B (乙) | XA11CCA351E002010304188 | NHSA |
| 温州海鹤药业有限公司 | 国药准字H20233213 | 0.75μg | Category B (乙) | XA11CCA351E002010304586 | NHSA |
| 珠海健福制药有限公司 | 国药准字H20244479 | 0.75μg | Category B (乙) | XA11CCA351E002010307011 | NHSA |
| 四川国为制药有限公司 | 国药准字H20233063 | 0.75μg | Category B (乙) | XA11CCA351E002010380937 | NHSA |
| 南京海融制药有限公司 | 国药准字H20234466 | 0.75μg | Category B (乙) | XA11CCA351E002010381812 | NHSA |
| 山东简道制药有限公司 | 国药准字H20256105 | 0.5μg | Category B (乙) | XA11CCA351E002010384386 | NHSA |
| 大连美创药业有限公司 | 国药准字H20234468 | 0.75μg | Category B (乙) | XA11CCA351E002010401121 | NHSA |
| 郑州泰丰制药有限公司 | 国药准字H20223700 | 0.75μg | Category B (乙) | XA11CCA351E002010403013 | NHSA |
| 山东新时代药业有限公司 | 国药准字H20255266 | 0.75µg | Category B (乙) | XA11CCA351E002010404188 | NHSA |
| 温州海鹤药业有限公司 | 国药准字H20233213 | 0.75μg | Category B (乙) | XA11CCA351E002010404586 | NHSA |
| 珠海健福制药有限公司 | 国药准字H20244479 | 0.75μg | Category B (乙) | XA11CCA351E002010407011 | NHSA |
| 南京海融制药有限公司 | 国药准字H20234466 | 0.75μg | Category B (乙) | XA11CCA351E002010481812 | NHSA |
| 大连美创药业有限公司 | 国药准字H20234468 | 0.75μg | Category B (乙) | XA11CCA351E002010501121 | NHSA |
| 郑州泰丰制药有限公司 | 国药准字H20223700 | 0.75μg | Category B (乙) | XA11CCA351E002010503013 | NHSA |
| 温州海鹤药业有限公司 | 国药准字H20233213 | 0.75μg | Category B (乙) | XA11CCA351E002010504586 | NHSA |
| 大连美创药业有限公司 | 国药准字H20234468 | 0.75μg | Category B (乙) | XA11CCA351E002010601121 | NHSA |
| 郑州泰丰制药有限公司 | 国药准字H20223700 | 0.75μg | Category B (乙) | XA11CCA351E002010603013 | NHSA |
| 温州海鹤药业有限公司 | 国药准字H20233213 | 0.75μg | Category B (乙) | XA11CCA351E002010604586 | NHSA |
| 正大天晴药业集团股份有限公司 | 国药准字H20253040 | 0.75μg | Category B (乙) | XA11CCA351E002020101523 | NHSA |
| 郑州泰丰制药有限公司 | 国药准字H20247029 | 0.5μg | Category B (乙) | XA11CCA351E002020103013 | NHSA |
| 珠海健福制药有限公司 | 国药准字H20244480 | 0.5μg | Category B (乙) | XA11CCA351E002020107011 | NHSA |
| 人福普克药业(武汉)有限公司 | 国药准字H20243290 | 0.5μg | Category B (乙) | XA11CCA351E002020109981 | NHSA |
| 南京海融制药有限公司 | 国药准字H20234465 | 0.5μg | Category B (乙) | XA11CCA351E002020181812 | NHSA |
| 山东简道制药有限公司 | 国药准字H20256106 | 0.75μg | Category B (乙) | XA11CCA351E002020184386 | NHSA |
| 郑州泰丰制药有限公司 | 国药准字H20247029 | 0.5μg | Category B (乙) | XA11CCA351E002020203013 | NHSA |
| 珠海健福制药有限公司 | 国药准字H20244480 | 0.5μg | Category B (乙) | XA11CCA351E002020207011 | NHSA |
| 人福普克药业(武汉)有限公司 | 国药准字H20243290 | 0.5μg | Category B (乙) | XA11CCA351E002020209981 | NHSA |
| Chugai Pharmaceutical Co., Ltd | 国药准字HJ20200058 | 0.75μg | Category B (乙) | XA11CCA351E002020279189 | NHSA |
| 南京海融制药有限公司 | 国药准字H20234465 | 0.5μg | Category B (乙) | XA11CCA351E002020281812 | NHSA |
| 山东简道制药有限公司 | 国药准字H20256106 | 0.75μg | Category B (乙) | XA11CCA351E002020284386 | NHSA |
| 郑州泰丰制药有限公司 | 国药准字H20247029 | 0.5μg | Category B (乙) | XA11CCA351E002020303013 | NHSA |
| 珠海健福制药有限公司 | 国药准字H20244480 | 0.5μg | Category B (乙) | XA11CCA351E002020307011 | NHSA |
| 山东简道制药有限公司 | 国药准字H20256106 | 0.75μg | Category B (乙) | XA11CCA351E002020384386 | NHSA |
| 郑州泰丰制药有限公司 | 国药准字H20247029 | 0.5μg | Category B (乙) | XA11CCA351E002020403013 | NHSA |
| 珠海健福制药有限公司 | 国药准字H20244480 | 0.5μg | Category B (乙) | XA11CCA351E002020407011 | NHSA |
| 郑州泰丰制药有限公司 | 国药准字H20247029 | 0.5μg | Category B (乙) | XA11CCA351E002020503013 | 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 5 distinct first applicants.
Supplement 1 · Generic 7
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 大连美创药业有限公司 | CYHB2601133 | Supplement | 2026/06/16 | Not stated by source | CDE |
| 海南斯达制药有限公司 | CYHS2601063 | Generic | 2026/05/09 | Not stated by source | CDE |
| 海南斯达制药有限公司 | CYHS2601061 | Generic | 2026/05/09 | Not stated by source | CDE |
| 海南葫芦娃药业集团股份有限公司 | CYHS2600421 | Generic | 2026/02/10 | Not stated by source | CDE |
| 海南葫芦娃药业集团股份有限公司 | CYHS2600420 | Generic | 2026/02/10 | Not stated by source | CDE |
| 浙江浙北药业有限公司 | CYHS2504191 | Generic | 2025/12/05 | Not stated by source | CDE |
| 浙江浙北药业有限公司 | CYHS2504190 | Generic | 2025/12/05 | Not stated by source | CDE |
| 辽宁鑫善源药业有限公司;大连美创药业有限公司 | CYHS2503728 | Generic | 2025/10/18 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 4 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 海南斯达制药有限公司 | CYHS2601063 | Generic | 2026/05/09 | Not stated by source | CDE |
| 海南斯达制药有限公司 | CYHS2601061 | Generic | 2026/05/09 | Not stated by source | CDE |
| 海南葫芦娃药业集团股份有限公司 | CYHS2600421 | Generic | 2026/02/10 | Not stated by source | CDE |
| 海南葫芦娃药业集团股份有限公司 | CYHS2600420 | Generic | 2026/02/10 | Not stated by source | CDE |
API registrations
Non-component matches: 11 companies with A status and 1 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 |
|---|---|---|---|---|---|---|
| 艾地骨化醇 | 长春海悦药业股份有限公司 | Y20240000452 | I | Exact ingredient | 2024/05/13 | CDE |
| 艾地骨化醇 | 郑州泰丰制药有限公司 | Y20230001070 | A | Exact ingredient | 2025/02/26 | CDE |
| 艾地骨化醇 | 青岛国信制药有限公司 | Y20230000401 | A | Exact ingredient | 2025/04/08 | CDE |
| 艾地骨化醇 | 甘肃皓天医药科技有限责任公司 | Y20230000482 | A | Exact ingredient | 2026/06/02 | CDE |
| 艾地骨化醇 | 四川科伦药业股份有限公司 | Y20230000297 | A | Exact ingredient | 2026/09/12 | CDE |
| 艾地骨化醇 | 博瑞制药（苏州）有限公司 | Y20220000173 | A | Exact ingredient | 2026/06/03 | CDE |
| 艾地骨化醇 | 大连美创药业有限公司 | Y20220000043 | A | Exact ingredient | 2026/09/21 | CDE |
| 艾地骨化醇 | 连云港润众制药有限公司 | Y20210000904 | A | Exact ingredient | 2023/06/28 | CDE |
| 艾地骨化醇 | 南京海融制药有限公司 | Y20210000737 | A | Exact ingredient | 2026/10/28 | CDE |
| 艾地骨化醇 | 温州海鹤药业有限公司 | Y20210000727 | A | Exact ingredient | 2023/03/03 | CDE |
| 艾地骨化醇 | 四川国为制药有限公司 | Y20210000439 | A | Exact ingredient | 2022/10/27 | CDE |
| 艾地骨化醇 | Nissan Chemical Corporation | Y20200000962 | A | Exact ingredient | 2025/09/11 | 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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