Monthly
US$200
Billed every month
Dydrogesterone Tablets(地屈孕酮片)
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationAccepted: 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 holders17View records ↓
Under-review filings9View records ↓
This year’s generic filers4View records ↓
NHSA approval numbers16View records ↓
API companies with A status4View records ↓
Chemical-drug catalogue
Loaded records: 17 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 16 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 |
|---|---|---|---|---|---|---|
| 合肥国高药业有限公司 | 江苏和晨药业有限公司 | 国药准字H20265162 | 2026/07/14 | 10mg | 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H20265026 | 2026/06/30 | 10mg | 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 |
| Cipla Ltd. | M/s Acme Formulation Pvt. Ltd. | 国药准字HJ20260065 | 2026/06/30 | 10mg | 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 |
| 北京法莫斯达制药科技有限公司 | 湖南醇健制药科技有限公司 | 国药准字H20264326 | 2026/05/12 | 10mg | 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 |
| 北京金城泰尔制药有限公司 | 浙江赛默制药有限公司 | 国药准字H20264067 | 2026/04/21 | 10mg | 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 |
| 嘉亨（珠海横琴）医药科技有限公司 | 江苏和晨药业有限公司 | 国药准字H20264068 | 2026/04/21 | 10mg | 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 |
| 广州朗圣药业有限公司 | 广州朗圣药业有限公司 | 国药准字H20263867 | 2026/04/07 | 10mg | 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 |
| 新疆特丰药业股份有限公司 | 新疆新姿源生物制药有限责任公司 | 国药准字H20263222 | 2026/01/27 | 10mg | 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 |
| 株洲千金药业股份有限公司 | 浙江赛默制药有限公司 | 国药准字H20256508 | 2025/12/30 | 10mg | 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 |
| 桂林朗科制药有限公司 | 浙江赛默制药有限公司 | 国药准字H20256502 | 2025/12/30 | 10mg | 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 |
| 浙江爱生药业有限公司 | 浙江爱生药业有限公司 | 国药准字H20255687 | 2025/10/14 | 10mg | 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 |
| 浙江仙琚制药股份有限公司 | 浙江仙琚制药股份有限公司 | 国药准字H20254052 | 2025/04/30 | 10mg | 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H20244872 | 2024/09/10 | 10mg | 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 |
| 杭州和泽坤元药业有限公司 | 扬州奥锐特药业有限公司 | 国药准字H20243163 | 2024/02/06 | 10mg | 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 |
| 奥锐特药业股份有限公司 | 扬州奥锐特药业有限公司 | 国药准字H20233769 | 2023/06/21 | 10mg | 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 |
| Abbott Healthcare Products B.V. | Abbott Biologicals B.V. | H20170221 | 2002/12/31 | 10mg | Imported originator drug (进口原研药品) | CDE |
| 浙江高跖医药科技股份有限公司 | 浙江赛默制药有限公司 | 国药准字H20254942 | 2025/07/22 | 10mg | 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: 16 distinct approval numbers and 16 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 北京金城泰尔制药有限公司 | 国药准字H20264067 | 10mg | Category B (乙) | XG03DBD084A001010100085 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20244872 | 10mg | Category B (乙) | XG03DBD084A001010102180 | NHSA |
| 河南泰丰生物科技有限公司 | 国药准字H20265026 | 10mg | Category B (乙) | XG03DBD084A001010103013 | NHSA |
| 浙江爱生药业有限公司 | 国药准字H20255687 | 10mg | Category B (乙) | XG03DBD084A001010104604 | NHSA |
| 浙江仙琚制药股份有限公司 | 国药准字H20254052 | 10mg | Category B (乙) | XG03DBD084A001010104735 | NHSA |
| 株洲千金药业股份有限公司 | 国药准字H20256508 | 10mg | Category B (乙) | XG03DBD084A001010105046 | NHSA |
| 新疆特丰药业股份有限公司 | 国药准字H20263222 | 10mg | Category B (乙) | XG03DBD084A001010105999 | NHSA |
| 广州朗圣药业有限公司 | 国药准字H20263867 | 10mg | Category B (乙) | XG03DBD084A001010107360 | NHSA |
| 北京法莫斯达制药科技有限公司 | 国药准字H20264326 | 10mg | Category B (乙) | XG03DBD084A001010107599 | NHSA |
| 奥锐特药业股份有限公司 | 国药准字H20233769 | 10mg | Category B (乙) | XG03DBD084A001010108121 | NHSA |
| Abbott B.V. | 国药准字HJ20170221 | 10mg | Category B (乙) | XG03DBD084A001010178890 | NHSA |
| 合肥国高药业有限公司 | 国药准字H20265162 | 10mg | Category B (乙) | XG03DBD084A001010183883 | NHSA |
| 嘉亨(珠海横琴)医药科技有限公司 | 国药准字H20264068 | 10mg | Category B (乙) | XG03DBD084A001010184183 | NHSA |
| 江苏和晨药业有限公司 | 国药准字H20243163 | 10mg | Category B (乙) | XG03DBD084A001010184206 | NHSA |
| 浙江高跖医药科技股份有限公司 | 国药准字H20254942 | 10mg | Category B (乙) | XG03DBD084A001010184221 | NHSA |
| 桂林朗科制药有限公司 | 国药准字H20256502 | 10mg | Category B (乙) | XG03DBD084A001010185157 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20244872 | 10mg | Category B (乙) | XG03DBD084A001010202180 | NHSA |
| 河南泰丰生物科技有限公司 | 国药准字H20265026 | 10mg | Category B (乙) | XG03DBD084A001010203013 | NHSA |
| 浙江爱生药业有限公司 | 国药准字H20255687 | 10mg | Category B (乙) | XG03DBD084A001010204604 | NHSA |
| 北京法莫斯达制药科技有限公司 | 国药准字H20264326 | 10mg | Category B (乙) | XG03DBD084A001010207599 | NHSA |
| 奥锐特药业股份有限公司 | 国药准字H20233769 | 10mg | Category B (乙) | XG03DBD084A001010208121 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20244872 | 10mg | Category B (乙) | XG03DBD084A001010302180 | NHSA |
| 河南泰丰生物科技有限公司 | 国药准字H20265026 | 10mg | Category B (乙) | XG03DBD084A001010303013 | NHSA |
| 北京法莫斯达制药科技有限公司 | 国药准字H20264326 | 10mg | Category B (乙) | XG03DBD084A001010307599 | NHSA |
| 奥锐特药业股份有限公司 | 国药准字H20233769 | 10mg | Category B (乙) | XG03DBD084A001010308121 | NHSA |
| 四川科伦药业股份有限公司 | 国药准字H20244872 | 10mg | Category B (乙) | XG03DBD084A001010402180 | NHSA |
| 北京法莫斯达制药科技有限公司 | 国药准字H20264326 | 10mg | Category B (乙) | XG03DBD084A001010407599 | NHSA |
| 北京法莫斯达制药科技有限公司 | 国药准字H20264326 | 10mg | Category B (乙) | XG03DBD084A001010507599 | 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 8 distinct first applicants.
Generic 7 · Supplement 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏诺泰澳赛诺生物制药股份有限公司 | CYHS2602566 | Generic | 2026/10/19 | Not stated by source | CDE |
| 上海延安药业有限公司;浙江赛默制药有限公司 | CYHS2602273 | Generic | 2026/09/15 | Not stated by source | CDE |
| Abbott B. V.;Abbott Biologicals B. V. | JYHB2600476 | Supplement | 2026/08/17 | Not stated by source | CDE |
| Abbott B. V.;Abbott Biologicals B. V. | JYHB2600379 | Supplement | 2026/07/13 | Not stated by source | CDE |
| 武汉九珑人福药业有限责任公司;四川科伦药业股份有限公司 | CYHS2601052 | Generic | 2026/05/08 | Not stated by source | CDE |
| 湖北民康药业集团有限公司;湖南醇健制药科技有限公司 | CYHS2600126 | Generic | 2026/01/10 | Not stated by source | CDE |
| 浙江神洲药业有限公司 | CYHS2504386 | Generic | 2025/12/25 | Not stated by source | CDE |
| 浙江美迪深生物医药有限公司;浙江仙琚制药股份有限公司 | CYHS2503570 | Generic | 2025/09/29 | Not stated by source | CDE |
| 北京斯利安药业有限公司 | CYHS2502270 | Generic | 2025/06/25 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 4 filings and 4 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏诺泰澳赛诺生物制药股份有限公司 | CYHS2602566 | Generic | 2026/10/19 | Not stated by source | CDE |
| 上海延安药业有限公司;浙江赛默制药有限公司 | CYHS2602273 | Generic | 2026/09/15 | Not stated by source | CDE |
| 武汉九珑人福药业有限责任公司;四川科伦药业股份有限公司 | CYHS2601052 | Generic | 2026/05/08 | Not stated by source | CDE |
| 湖北民康药业集团有限公司;湖南醇健制药科技有限公司 | CYHS2600126 | Generic | 2026/01/10 | Not stated by source | CDE |
API registrations
Non-component matches: 4 companies with A status and 5 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 |
|---|---|---|---|---|---|---|
| 地屈孕酮 | 兰州特丰制药有限公司 | Y20250000513 | I | Exact ingredient | 2026/08/27 | CDE |
| 地屈孕酮 | 四川仁安药业有限责任公司 | Y20250001439 | I | Exact ingredient | 2026/03/17 | CDE |
| 地屈孕酮 | 秦皇岛紫竹药业有限公司 | Y20260000036 | I | Exact ingredient | 2026/02/14 | CDE |
| 地屈孕酮 | 浙江神洲药业有限公司 | Y20250000718 | I | Exact ingredient | 2025/12/08 | CDE |
| 地屈孕酮 | 湖南科益新生物医药有限公司 | Y20240000900 | A | Exact ingredient | 2026/03/31 | CDE |
| 地屈孕酮 | 江苏佳尔科药业集团股份有限公司 | Y20240000058 | A | Exact ingredient | 2025/07/18 | CDE |
| 地屈孕酮 | 浙江仙琚制药股份有限公司 | Y20230000883 | A | Exact ingredient | 2025/04/28 | CDE |
| 地屈孕酮 | 扬州奥锐特药业有限公司 | Y20210001253 | A | Exact ingredient | 2023/06/29 | CDE |
| 地屈孕酮 | 西安国康瑞金制药有限公司 | Y20210000734 | I | Exact ingredient | 2021/09/23 | 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.
-
2026/10/26Marketing application approved
深圳市泛谷药业股份有限公司
JYHS2500004 · 国药准字HJ20260092
Fact date: 2026/10/26 · Publication date: 2026/10/27 · Site observation date: 2026/11/03
The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.
View source · Table row 70 ↗ -
2026/10/19Accepted
江苏诺泰澳赛诺生物制药股份有限公司
CYHS2602566
Fact date: 2026/10/19 · Site observation date: 2026/10/21
View source ↗ -
2026/09/15Accepted
上海延安药业有限公司;浙江赛默制药有限公司
CYHS2602273
Fact date: 2026/09/15 · Site observation date: 2026/10/22
View source ↗ -
2026/08/17Accepted
Abbott B. V.;Abbott Biologicals B. V.
JYHB2600476
Fact date: 2026/08/17 · Site observation date: 2026/10/22
View source ↗
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.
Free follow
Follow changes to Dydrogesterone Tablets
Up to 3 drugs per email address, in one weekly digest. Starts after email confirmation; unsubscribe at any time.
Subscriptions
Next-day facts and deliverable timelines
- One email the next day when new facts are collected for your followed products.
- Export the complete loaded event timeline for each followed product as CSV.
- Add up to 4 additional recipients, each confirmed by email.
- Increase your follow limit from 3 to 10 products.
Quarterly
US$540
Billed every three months
US$180 per month
Yearly
US$1,920
Billed every year
US$160 per month
Online subscriptions are not enabled. The form below registers interest; it does not charge or activate access.
Separate one-time purchase
US Orange Book × China records comparison
Full table and CSV export for 12 months from payment, with monthly data updates. No automatic renewal.
Subscriptions and comparison-table access are purchased separately. Neither includes the other.
US$490
One payment · 12 months of access
Online comparison-table purchase is not enabled.
Billed by Creem, our merchant of record · Terms · Refund policy