Monthly
US$200
Billed every month
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 1 application
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: 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 |
|---|---|---|---|---|---|---|
| 北京星昊医药股份有限公司 | 北京星昊医药股份有限公司 | 国药准字H20265835 | 2026/09/02 | 0.4g | 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 |
| 浙江普洛康裕制药有限公司 | 浙江普洛康裕制药有限公司 | 国药准字H20265601 | 2026/08/04 | 0.4g | 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 |
| 杭州康恩贝制药有限公司 | 杭州康恩贝制药有限公司 | 国药准字H20265021 | 2026/06/30 | 0.4g | 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 |
| 福建海西新药创制股份有限公司 | 广东安诺药业股份有限公司 | 国药准字H20264886 | 2026/06/17 | 0.4g | 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 |
| 广州仁恒医药科技股份有限公司 | 湖南九典制药股份有限公司 | 国药准字H20264838 | 2026/06/17 | 0.4g | 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 |
| 海南皇隆制药股份有限公司 | 海南皇隆制药股份有限公司 | 国药准字H20263517 | 2026/03/03 | 0.4g | 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 |
| 本溪匠成医药科技有限公司 | 吉林四环制药有限公司 | 国药准字H20263516 | 2026/03/03 | 0.4g | 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 |
| 江苏慧聚药业股份有限公司 | 华益泰康药业股份有限公司 | 国药准字H20263473 | 2026/02/25 | 0.4g | 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 |
| 广州市联瑞制药有限公司 | 广州市联瑞制药有限公司 | 国药准字H20256070 | 2025/11/25 | 0.4g | 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 |
| 苏州中化药品工业有限公司 | 苏州中化药品工业有限公司 | 国药准字H20255883 | 2025/11/04 | 0.4g | 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 |
| 普济生物科技(台州)有限公司 | 乐普制药科技有限公司 | 国药准字H20255377 | 2025/09/09 | 0.4g | 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 |
| 广东君康药业有限公司 | 天津药物研究院药业有限责任公司 | 国药准字H20255347 | 2025/09/09 | 0.4g | 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 |
| 山东京卫制药有限公司 | 山东京卫制药有限公司 | 国药准字H20255255 | 2025/08/26 | 0.4g | 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 |
| 石药集团中诺药业(石家庄)有限公司 | 石药集团欧意药业有限公司 | 国药准字H20255008 | 2025/07/29 | 0.4g | 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 |
| 杭州呋欧医药科技有限公司 | 浙江赛默制药有限公司 | 国药准字H20254845 | 2025/07/15 | 0.4g | Not stated by source | CDE |
| 浙江高跖医药科技股份有限公司 | 江苏永安制药有限公司 | 国药准字H20253544 | 2025/03/04 | 0.4g | 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 |
| 石家庄四药有限公司 | 石家庄四药有限公司 | 国药准字H20233310 | 2023/03/21 | 0.4g | 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.
Loaded records: 18 distinct approval numbers and 18 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 北京星昊医药股份有限公司 | 国药准字H20265835 | 0.4g | Category B (乙) | XC04ADJ014A010010100198 | NHSA |
| 江苏慧聚药业股份有限公司 | 国药准字H20263473 | 0.4g | Category B (乙) | XC04ADJ014A010010101411 | NHSA |
| 苏州中化药品工业有限公司 | 国药准字H20255883 | 0.4g | Category B (乙) | XC04ADJ014A010010101679 | NHSA |
| 石家庄四药有限公司 | 国药准字H20233310 | 0.4g | Category B (乙) | XC04ADJ014A010010102763 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H10970265 | 0.4g | Category B (乙) | XC04ADJ014A010010102770 | NHSA |
| 石药集团中诺药业(石家庄)有限公司 | 国药准字H20255008 | 0.4g | Category B (乙) | XC04ADJ014A010010102777 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20255255 | 0.4g | Category B (乙) | XC04ADJ014A010010104111 | NHSA |
| 浙江普洛康裕制药有限公司 | 国药准字H20265601 | 0.4g | Category B (乙) | XC04ADJ014A010010104685 | NHSA |
| 海南皇隆制药股份有限公司 | 国药准字H20263517 | 0.4g | Category B (乙) | XC04ADJ014A010010105781 | NHSA |
| 福建海西新药创制股份有限公司 | 国药准字H20264886 | 0.4g | Category B (乙) | XC04ADJ014A010010183014 | NHSA |
| 河北一品生物医药有限公司 | 国药准字H20256017 | 0.4g | Category B (乙) | XC04ADJ014A010010183114 | NHSA |
| 广州市联瑞制药有限公司 | 国药准字H20256070 | 0.4g | Category B (乙) | XC04ADJ014A010010183238 | NHSA |
| 广州仁恒医药科技股份有限公司 | 国药准字H20264838 | 0.4g | Category B (乙) | XC04ADJ014A010010184019 | NHSA |
| 杭州呋欧医药科技有限公司 | 国药准字H20254845 | 0.4g | Category B (乙) | XC04ADJ014A010010184160 | NHSA |
| 广东君康药业有限公司 | 国药准字H20255347 | 0.4g | Category B (乙) | XC04ADJ014A010010184179 | NHSA |
| 普济生物科技(台州)有限公司 | 国药准字H20255377 | 0.4g | Category B (乙) | XC04ADJ014A010010184207 | NHSA |
| 浙江高跖医药科技股份有限公司 | 国药准字H20253544 | 0.4g | Category B (乙) | XC04ADJ014A010010184221 | NHSA |
| 本溪匠成医药科技有限公司 | 国药准字H20263516 | 0.4g | Category B (乙) | XC04ADJ014A010010184715 | NHSA |
| 北京星昊医药股份有限公司 | 国药准字H20265835 | 0.4g | Category B (乙) | XC04ADJ014A010010200198 | NHSA |
| 苏州中化药品工业有限公司 | 国药准字H20255883 | 0.4g | Category B (乙) | XC04ADJ014A010010201679 | NHSA |
| 石家庄四药有限公司 | 国药准字H20233310 | 0.4g | Category B (乙) | XC04ADJ014A010010202763 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H10970265 | 0.4g | Category B (乙) | XC04ADJ014A010010202770 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20255255 | 0.4g | Category B (乙) | XC04ADJ014A010010204111 | NHSA |
| 浙江普洛康裕制药有限公司 | 国药准字H20265601 | 0.4g | Category B (乙) | XC04ADJ014A010010204685 | NHSA |
| 海南皇隆制药股份有限公司 | 国药准字H20263517 | 0.4g | Category B (乙) | XC04ADJ014A010010205781 | NHSA |
| 福建海西新药创制股份有限公司 | 国药准字H20264886 | 0.4g | Category B (乙) | XC04ADJ014A010010283014 | NHSA |
| 河北一品生物医药有限公司 | 国药准字H20256017 | 0.4g | Category B (乙) | XC04ADJ014A010010283114 | NHSA |
| 广州市联瑞制药有限公司 | 国药准字H20256070 | 0.4g | Category B (乙) | XC04ADJ014A010010283238 | NHSA |
| 广州仁恒医药科技股份有限公司 | 国药准字H20264838 | 0.4g | Category B (乙) | XC04ADJ014A010010284019 | NHSA |
| 杭州呋欧医药科技有限公司 | 国药准字H20254845 | 0.4g | Category B (乙) | XC04ADJ014A010010284160 | NHSA |
| 广东君康药业有限公司 | 国药准字H20255347 | 0.4g | Category B (乙) | XC04ADJ014A010010284179 | NHSA |
| 普济生物科技(台州)有限公司 | 国药准字H20255377 | 0.4g | Category B (乙) | XC04ADJ014A010010284207 | NHSA |
| 浙江高跖医药科技股份有限公司 | 国药准字H20253544 | 0.4g | Category B (乙) | XC04ADJ014A010010284221 | NHSA |
| 苏州中化药品工业有限公司 | 国药准字H20255883 | 0.4g | Category B (乙) | XC04ADJ014A010010301679 | NHSA |
| 石家庄四药有限公司 | 国药准字H20233310 | 0.4g | Category B (乙) | XC04ADJ014A010010302763 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H10970265 | 0.4g | Category B (乙) | XC04ADJ014A010010302770 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20255255 | 0.4g | Category B (乙) | XC04ADJ014A010010304111 | NHSA |
| 浙江普洛康裕制药有限公司 | 国药准字H20265601 | 0.4g | Category B (乙) | XC04ADJ014A010010304685 | NHSA |
| 福建海西新药创制股份有限公司 | 国药准字H20264886 | 0.4g | Category B (乙) | XC04ADJ014A010010383014 | NHSA |
| 河北一品生物医药有限公司 | 国药准字H20256017 | 0.4g | Category B (乙) | XC04ADJ014A010010383114 | NHSA |
| 广州仁恒医药科技股份有限公司 | 国药准字H20264838 | 0.4g | Category B (乙) | XC04ADJ014A010010384019 | NHSA |
| 杭州呋欧医药科技有限公司 | 国药准字H20254845 | 0.4g | Category B (乙) | XC04ADJ014A010010384160 | NHSA |
| 普济生物科技(台州)有限公司 | 国药准字H20255377 | 0.4g | Category B (乙) | XC04ADJ014A010010384207 | NHSA |
| 苏州中化药品工业有限公司 | 国药准字H20255883 | 0.4g | Category B (乙) | XC04ADJ014A010010401679 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H10970265 | 0.4g | Category B (乙) | XC04ADJ014A010010402770 | NHSA |
| 山东京卫制药有限公司 | 国药准字H20255255 | 0.4g | Category B (乙) | XC04ADJ014A010010404111 | NHSA |
| 广州仁恒医药科技股份有限公司 | 国药准字H20264838 | 0.4g | Category B (乙) | XC04ADJ014A010010484019 | NHSA |
| 杭州呋欧医药科技有限公司 | 国药准字H20254845 | 0.4g | Category B (乙) | XC04ADJ014A010010484160 | NHSA |
| 普济生物科技(台州)有限公司 | 国药准字H20255377 | 0.4g | Category B (乙) | XC04ADJ014A010010484207 | NHSA |
| 石药集团欧意药业有限公司 | 国药准字H10970265 | 0.4g | Category B (乙) | XC04ADJ014A010010502770 | NHSA |
| 广州仁恒医药科技股份有限公司 | 国药准字H20264838 | 0.4g | Category B (乙) | XC04ADJ014A010010584019 | NHSA |
| 普济生物科技(台州)有限公司 | 国药准字H20255377 | 0.4g | Category B (乙) | XC04ADJ014A010010584207 | NHSA |
| 广州仁恒医药科技股份有限公司 | 国药准字H20264838 | 0.4g | Category B (乙) | XC04ADJ014A010010684019 | 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: 6 filings and 6 distinct first applicants.
Supplement 1 · Generic 5
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 合肥国高药业有限公司;江苏和晨药业有限公司 | CYHB2601752 | Supplement | 2026/09/17 | Not stated by source | CDE |
| 江苏和晨药业有限公司 | CYHS2500044 | Generic | 2025/01/04 | Not stated by source | CDE |
| 国药集团容生制药有限公司;江苏永安制药有限公司 | CYHS2600403 | Generic | 2026/02/07 | Not stated by source | CDE |
| 黑龙江亿达鸿药业有限公司 | CYHS2601283 | Generic | 2026/06/04 | Not stated by source | CDE |
| 浙江众延医药科技有限公司;石家庄市华新药业有限责任公司 | CYHS2600230 | Generic | 2026/01/20 | Not stated by source | CDE |
| 华益药业科技(安徽)有限公司 | CYHS2403035 | Generic | 2024/09/12 | Not stated by source | CDE |
Loaded records: 3 filings and 3 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 国药集团容生制药有限公司;江苏永安制药有限公司 | CYHS2600403 | Generic | 2026/02/07 | Not stated by source | CDE |
| 黑龙江亿达鸿药业有限公司 | CYHS2601283 | Generic | 2026/06/04 | Not stated by source | CDE |
| 浙江众延医药科技有限公司;石家庄市华新药业有限责任公司 | CYHS2600230 | Generic | 2026/01/20 | Not stated by source | CDE |
Non-component matches: 15 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 |
|---|---|---|---|---|---|---|
| 己酮可可碱 | 丹东医创药业有限责任公司 | Y20250000604 | I | Exact ingredient | 2025/07/16 | CDE |
| 己酮可可碱 | 河北一品制药股份有限公司 | Y20240000724 | I | Exact ingredient | 2024/07/24 | CDE |
| 己酮可可碱 | 吉林汇康制药有限公司 | Y20240000402 | A | Exact ingredient | 2025/12/10 | CDE |
| 己酮可可碱 | 赤峰万泽药业股份有限公司 | Y20230001239 | A | Exact ingredient | 2025/11/03 | CDE |
| 己酮可可碱 | 酒泉大得利制药股份有限公司 | Y20230000412 | A | Exact ingredient | 2025/04/07 | CDE |
| 己酮可可碱 | 南通常佑药业科技有限公司 | Y20230000230 | A | Exact ingredient | 2025/08/10 | CDE |
| 己酮可可碱 | SUN PHARMACEUTICAL INDUSTRIES LTD. | Y20220000937 | A | Exact ingredient | 2024/11/07 | CDE |
| 己酮可可碱 | 安徽恒星制药有限公司 | Y20220000743 | A | Exact ingredient | 2024/08/10 | CDE |
| 己酮可可碱 | 上海旭东海普药业有限公司 | Y20220000799 | A | Exact ingredient | 2024/05/30 | CDE |
| 己酮可可碱 | Hikal Limited | Y20210001229 | I | Exact ingredient | 2022/04/29 | CDE |
| 己酮可可碱 | PHARMACEUTICAL WORKS POLPHARMA S.A. | Y20210000211 | A | Exact ingredient | 2024/07/09 | CDE |
| 己酮可可碱 | 重庆瑞泊莱制药有限公司 | Y20210000669 | A | Exact ingredient | 2025/01/27 | CDE |
| 己酮可可碱 | FLEMING LABORATORIES LTD | Y20210000649 | A | Exact ingredient | 2025/06/08 | CDE |
| 己酮可可碱 | BAKUL PHARMA PRIVATE LIMITED | Y20200001449 | A | Exact ingredient | 2025/12/25 | CDE |
| 己酮可可碱 | 河北广祥制药有限公司 | Y20200001394 | A | Exact ingredient | 2026/10/13 | CDE |
| 己酮可可碱 | SOLARA ACTIVE PHARMA SCIENCES LIMITED | Y20200001064 | A | Exact ingredient | 2023/05/16 | CDE |
| 己酮可可碱 | 石药创新制药股份有限公司 | Y20190005020 | A | Exact ingredient | 2025/06/12 | CDE |
| 己酮可可碱 | Sanofi India Limited | Y20170001717 | I | Exact ingredient | — | CDE |
| 己酮可可碱 | ZAKLADY FARMACEUTYCZNE POLPHARMA S.A. | Y20170000764 | A | Exact ingredient | 2026/07/24 | 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.
CYHB2601752
Fact date: 2026/09/17 · Site observation date: 2026/10/21
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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Separate one-time purchase
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
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