Monthly
US$200
Billed every month
Alfacalcidol Soft Capsules(阿法骨化醇软胶囊)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 3 applications
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 holders12View records ↓
Under-review filings9View records ↓
This year’s generic filers3View records ↓
NHSA approval numbers24View records ↓
API companies with A status9View records ↓
Chemical-drug catalogue
Loaded records: 12 holders; 4 in the quality-and-efficacy consistency-evaluation category, and 6 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 |
|---|---|---|---|---|---|---|
| 南京海鲸药业股份有限公司 | 南京海鲸药业股份有限公司 | 国药准字H20264557 | 2026/05/27 | 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 |
| 南京海鲸药业股份有限公司 | 南京海鲸药业股份有限公司 | 国药准字H20264556 | 2026/05/27 | 1μg | 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 |
| 南京海鲸药业股份有限公司 | 南京海鲸药业股份有限公司 | 国药准字H20264558 | 2026/05/27 | 0.25μg | 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 |
| 南通华山药业有限公司 | 南通华山药业有限公司 | 国药准字H20000065 | 2026/05/25 | 0.25μg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 湖南银泽华浩生物科技有限公司 | 南通华山药业有限公司 | 国药准字H20264157 | 2026/04/29 | 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 |
| 湖南银泽华浩生物科技有限公司 | 南通华山药业有限公司 | 国药准字H20264156 | 2026/04/29 | 0.25μg | 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H20264113 | 2026/04/21 | 0.25μg | 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H20264114 | 2026/04/21 | 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 |
| 广州白云山星群（药业）股份有限公司 | 广州白云山星群（药业）股份有限公司 | 国药准字H20020501 | 2026/02/03 | 0.25μg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 广州白云山星群（药业）股份有限公司 | 广州白云山星群（药业）股份有限公司 | 国药准字H20051861 | 2026/02/03 | 0.5μg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | 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H20263351 | 2026/02/02 | 0.25μg | 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H20263350 | 2026/02/02 | 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 |
| 东海制药（河北）有限公司 | 东海制药（河北）有限公司 | 国药准字H20263244 | 2026/01/27 | 0.25μg | 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 |
| 北京万辉双鹤药业有限责任公司 | 华润双鹤药业股份有限公司 | 国药准字H20255672 | 2025/10/14 | 0.25μg | 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 |
| 昆明贝克诺顿制药有限公司 | 昆明贝克诺顿制药有限公司 | 国药准字H20010320 | 2021/02/02 | 0.25μg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 正大制药（青岛）有限公司 | 正大制药（青岛）有限公司 | 国药准字H19991114 | 2021/01/22 | 0.25μg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| LEO Pharma A/S | LEO Pharma A/S | H20130513 | 1998/07/09 | 0.25μg | Imported originator drug (进口原研药品) | CDE |
| Teva Pharmaceutical Industries Ltd. | Teva Pharmaceutical Industries Ltd. | H20171202;H20171203 | 1993/03/25 | 0.25μg | 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.
NHSA drug codes
Loaded records: 24 distinct approval numbers and 14 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H20263350 | 0.5μg | Category B (乙) | XA11CCA017E002010101121 | NHSA |
| 人福普克药业(武汉)有限公司 | 国药准字H20264113 | 0.25μg | Category B (乙) | XA11CCA017E002010109981 | NHSA |
| 湖南银泽华浩生物科技有限公司 | 国药准字H20264156 | 0.25μg | Category B (乙) | XA11CCA017E002010183641 | NHSA |
| 安睿制药(河北)有限公司 | 国药准字H20263244 | 0.25μg | Category B (乙) | XA11CCA017E002010184599 | NHSA |
| 大连美创药业有限公司 | 国药准字H20263350 | 0.5μg | Category B (乙) | XA11CCA017E002010201121 | NHSA |
| 湖南银泽华浩生物科技有限公司 | 国药准字H20264156 | 0.25μg | Category B (乙) | XA11CCA017E002010283641 | NHSA |
| 安睿制药(河北)有限公司 | 国药准字H20263244 | 0.25μg | Category B (乙) | XA11CCA017E002010284599 | NHSA |
| 大连美创药业有限公司 | 国药准字H20263350 | 0.5μg | Category B (乙) | XA11CCA017E002010301121 | NHSA |
| 湖南银泽华浩生物科技有限公司 | 国药准字H20264156 | 0.25μg | Category B (乙) | XA11CCA017E002010383641 | NHSA |
| 安睿制药(河北)有限公司 | 国药准字H20263244 | 0.25μg | Category B (乙) | XA11CCA017E002010384599 | NHSA |
| 安睿制药(河北)有限公司 | 国药准字H20263244 | 0.25μg | Category B (乙) | XA11CCA017E002010484599 | NHSA |
| 大连美创药业有限公司 | 国药准字H20263351 | 0.25μg | Category B (乙) | XA11CCA017E002020101121 | NHSA |
| 人福普克药业(武汉)有限公司 | 国药准字H20264114 | 0.5μg | Category B (乙) | XA11CCA017E002020109981 | NHSA |
| 湖南银泽华浩生物科技有限公司 | 国药准字H20264157 | 0.5μg | Category B (乙) | XA11CCA017E002020183641 | NHSA |
| 大连美创药业有限公司 | 国药准字H20263351 | 0.25μg | Category B (乙) | XA11CCA017E002020201121 | NHSA |
| 湖南银泽华浩生物科技有限公司 | 国药准字H20264157 | 0.5μg | Category B (乙) | XA11CCA017E002020283641 | NHSA |
| 大连美创药业有限公司 | 国药准字H20263351 | 0.25μg | Category B (乙) | XA11CCA017E002020301121 | NHSA |
| 湖南银泽华浩生物科技有限公司 | 国药准字H20264157 | 0.5μg | Category B (乙) | XA11CCA017E002020383641 | NHSA |
| 华润双鹤药业股份有限公司 | 国药准字H20074109 | 0.25μg | Category B (乙) | XA11CCA017E002010100143 | NHSA |
| 北京万辉双鹤药业有限责任公司 | 国药准字H20255672 | 0.25μg | Category B (乙) | XA11CCA017E002010100176 | NHSA |
| 广州白云山星群(药业)股份有限公司 | 国药准字H20020501 | 0.25μg | Category B (乙) | XA11CCA017E002010100423 | NHSA |
| 上海信谊万象药业股份有限公司 | 国药准字H20010618 | 0.25μg | Category B (乙) | XA11CCA017E002010100805 | NHSA |
| 南通华山药业有限公司 | 国药准字H20000065 | 0.25μg | Category B (乙) | XA11CCA017E002010101620 | NHSA |
| 青岛国信制药有限公司 | 国药准字H19991114 | 0.25μg | Category B (乙) | XA11CCA017E002010104036 | NHSA |
| Teva Pharmaceutical Industries Ltd. | 国药准字J20171090 | 0.25μg | Category B (乙) | XA11CCA017E002010105580 | NHSA |
| Teva Pharmaceutical Industries Ltd. | H20171202 | 0.25μg | Category B (乙) | XA11CCA017E002010178914 | NHSA |
| CHEPLAPHARM Arzneimittel GmbH | 国药准字HJ20130513 | 0.25μg | Category B (乙) | XA11CCA017E002010179051 | NHSA |
| 华润双鹤药业股份有限公司 | 国药准字H20074109 | 0.25μg | Category B (乙) | XA11CCA017E002010200143 | NHSA |
| 北京万辉双鹤药业有限责任公司 | 国药准字H20255672 | 0.25μg | Category B (乙) | XA11CCA017E002010200176 | NHSA |
| 广州白云山星群(药业)股份有限公司 | 国药准字H20020501 | 0.25μg | Category B (乙) | XA11CCA017E002010200423 | NHSA |
| 上海信谊万象药业股份有限公司 | 国药准字H20010618 | 0.25μg | Category B (乙) | XA11CCA017E002010200805 | NHSA |
| 南通华山药业有限公司 | 国药准字H20000065 | 0.25μg | Category B (乙) | XA11CCA017E002010201620 | NHSA |
| 青岛国信制药有限公司 | 国药准字H19991114 | 0.25μg | Category B (乙) | XA11CCA017E002010204036 | NHSA |
| Teva Pharmaceutical Industries Ltd. | 国药准字J20171090 | 0.25μg | Category B (乙) | XA11CCA017E002010205580 | NHSA |
| Teva Pharmaceutical Industries Ltd. | H20171202 | 0.25μg | Category B (乙) | XA11CCA017E002010278914 | NHSA |
| 南通华山药业有限公司 | 国药准字H20000065 | 0.25μg | Category B (乙) | XA11CCA017E002010301620 | NHSA |
| 青岛国信制药有限公司 | 国药准字H19991114 | 0.25μg | Category B (乙) | XA11CCA017E002010304036 | NHSA |
| 昆明贝克诺顿制药有限公司 | 国药准字H20010320 | 0.25μg | Category B (乙) | XA11CCA017E002010305580 | NHSA |
| 青岛国信制药有限公司 | 国药准字H19991114 | 0.25μg | Category B (乙) | XA11CCA017E002010404036 | NHSA |
| 昆明贝克诺顿制药有限公司 | 国药准字H20010320 | 0.25μg | Category B (乙) | XA11CCA017E002010405580 | NHSA |
| 青岛国信制药有限公司 | 国药准字H19991114 | 0.25μg | Category B (乙) | XA11CCA017E002010504036 | NHSA |
| 广州白云山星群(药业)股份有限公司 | 国药准字H20051861 | 0.5μg | Category B (乙) | XA11CCA017E002020100423 | NHSA |
| 上海信谊万象药业股份有限公司 | 国药准字H20010619 | 0.5μg | Category B (乙) | XA11CCA017E002020100805 | NHSA |
| 南通华山药业有限公司 | 国药准字H20000066 | 0.5μg | Category B (乙) | XA11CCA017E002020101620 | NHSA |
| Teva Pharmaceutical Industries Ltd. | 国药准字J20171093 | 1μg | Category B (乙) | XA11CCA017E002020105580 | NHSA |
| Teva Pharmaceutical Industries Ltd. | H20171205 | 1μg | Category B (乙) | XA11CCA017E002020178914 | NHSA |
| CHEPLAPHARM Arzneimittel GmbH | 国药准字HJ20130514 | 1μg | Category B (乙) | XA11CCA017E002020179051 | NHSA |
| 广州白云山星群(药业)股份有限公司 | 国药准字H20051861 | 0.5μg | Category B (乙) | XA11CCA017E002020200423 | NHSA |
| 上海信谊万象药业股份有限公司 | 国药准字H20010619 | 0.5μg | Category B (乙) | XA11CCA017E002020200805 | NHSA |
| 大连奥森制药有限公司 | 国药准字H20067903 | 0.25μg | Category B (乙) | XA11CCA017E002020201137 | NHSA |
| 南通华山药业有限公司 | 国药准字H20000066 | 0.5μg | Category B (乙) | XA11CCA017E002020201620 | NHSA |
| 大连奥森制药有限公司 | 国药准字H20067903 | 0.25μg | Category B (乙) | XA11CCA017E002020301137 | NHSA |
| 南通华山药业有限公司 | 国药准字H20000066 | 0.5μg | Category B (乙) | XA11CCA017E002020301620 | NHSA |
| 大连奥森制药有限公司 | 国药准字H20067903 | 0.25μg | Category B (乙) | XA11CCA017E002020401137 | NHSA |
| 大连奥森制药有限公司 | 国药准字H20067903 | 0.25μg | Category B (乙) | XA11CCA017E002020501137 | NHSA |
| 大连奥森制药有限公司 | 国药准字H20067903 | 0.25μg | Category B (乙) | XA11CCA017E002020601137 | NHSA |
| 大连奥森制药有限公司 | 国药准字H20067903 | 0.25μg | Category B (乙) | XA11CCA017E002020701137 | NHSA |
| 大连奥森制药有限公司 | 国药准字H20067903 | 0.25μg | Category B (乙) | XA11CCA017E002020801137 | NHSA |
| 大连奥森制药有限公司 | 国药准字H20067903 | 0.25μg | Category B (乙) | XA11CCA017E002020901137 | NHSA |
| 大连奥森制药有限公司 | 国药准字H20067903 | 0.25μg | Category B (乙) | XA11CCA017E002021001137 | 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: 9 filings and 7 distinct first applicants.
Generic 6 · Supplement 3
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 辽宁鑫善源药业有限公司;大连美创药业有限公司 | CYHS2602098 | Generic | 2026/08/24 | 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 | CYHS2602097 | Generic | 2026/08/24 | Not stated by source | CDE |
| 大连奥森制药有限公司 | CYHB2650174 | Supplement | 2026/08/20 | Not stated by source | CDE |
| 青岛双鲸药业股份有限公司 | CYHS2601939 | Generic | 2026/08/10 | Not stated by source | CDE |
| 山东简道制药有限公司 | CYHS2600677 | Generic | 2026/03/19 | Not stated by source | CDE |
| 上海信谊万象药业股份有限公司 | CYHB2650008 | Supplement | 2026/01/08 | Not stated by source | CDE |
| 石家庄科仁医药科技有限公司 | CYHS2503283 | Generic | 2025/09/05 | Not stated by source | CDE |
| 石家庄科仁医药科技有限公司 | CYHS2503282 | Generic | 2025/09/05 | Not stated by source | CDE |
| 青岛国信制药有限公司 | CYHB2501261 | Supplement | 2025/06/27 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 4 filings and 3 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 辽宁鑫善源药业有限公司;大连美创药业有限公司 | CYHS2602098 | Generic | 2026/08/24 | 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 | CYHS2602097 | Generic | 2026/08/24 | Not stated by source | CDE |
| 青岛双鲸药业股份有限公司 | CYHS2601939 | Generic | 2026/08/10 | Not stated by source | CDE |
| 山东简道制药有限公司 | CYHS2600677 | Generic | 2026/03/19 | Not stated by source | CDE |
API registrations
Non-component matches: 9 companies with A status and 4 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 |
|---|---|---|---|---|---|---|
| 阿法骨化醇 | 河北创健药业有限公司 | Y20240001503 | I | Exact ingredient | 2025/07/03 | CDE |
| 阿法骨化醇 | Formosa Laboratories, Inc. | Y20230000706 | A | Exact ingredient | 2026/05/20 | CDE |
| 阿法骨化醇 | 上海信谊万象药业股份有限公司 | Y20230000101 | A | Exact ingredient | 2024/09/24 | CDE |
| 阿法骨化醇 | 无锡福祈制药有限公司 | Y20210000218 | I | Exact ingredient | 2021/04/13 | CDE |
| 阿法骨化醇 | 重庆药友制药有限责任公司 | Y20190009700 | A | Exact ingredient | — | CDE |
| 阿法骨化醇 | 青岛国信制药有限公司 | Y20190009399 | A | Exact ingredient | 2025/01/15 | CDE |
| 阿法骨化醇 | 华润双鹤药业股份有限公司 | Y20190006915 | A | Exact ingredient | 2023/03/24 | CDE |
| 阿法骨化醇 | 浙江普洛康裕制药有限公司 | Y20190002277 | A | Exact ingredient | 2024/12/07 | CDE |
| 阿法骨化醇 | 重庆药友制药有限责任公司 | Y20180001705 | A | Exact ingredient | 2025/09/27 | CDE |
| 阿法骨化醇 | 正大制药（青岛）有限公司 | Y20180000360 | I | Exact ingredient | 2018/08/27 | CDE |
| 阿法骨化醇 | 南京海融制药有限公司 | Y20180000715 | A | Exact ingredient | 2025/03/23 | CDE |
| 阿法骨化醇 | 上海信谊万象药业股份有限公司 | Y20170001885 | I | Exact ingredient | — | CDE |
| 阿法骨化醇 | 台耀化学股份有限公司 | Y20170000266 | A | Exact ingredient | 2022/09/05 | CDE |
| 阿法骨化醇 | CARBOGEN AMCIS B.V. | Y20170000231 | A | Exact ingredient | 2024/11/20 | 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.
-
2026/08/24Accepted
辽宁鑫善源药业有限公司;大连美创药业有限公司
CYHS2602098
Fact date: 2026/08/24 · Site observation date: 2026/10/22
View source ↗ -
2026/08/24Accepted
辽宁鑫善源药业有限公司;大连美创药业有限公司
CYHS2602097
Fact date: 2026/08/24 · Site observation date: 2026/10/22
View source ↗ -
2026/08/20Accepted
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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