Monthly
US$200
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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
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: 4 holders; 1 in the quality-and-efficacy consistency-evaluation category, and 3 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 |
|---|---|---|---|---|---|---|
| 瑞阳制药股份有限公司 | 瑞阳制药股份有限公司 | 国药准字H20255836 | 2025/11/04 | 0.25g(按C16H16N4O8S计) | 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 |
| 瑞阳制药股份有限公司 | 瑞阳制药股份有限公司 | 国药准字H20255837 | 2025/11/04 | 0.125g(按C16H16N4O8S计) | 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 |
| 山东鲁抗医药股份有限公司 | 成都倍特药业股份有限公司 | 国药准字H20010810 | 2025/06/18 | 0.125g(按C16H16N4O8S计) | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 石家庄四药有限公司 | 石家庄四药有限公司 | 国药准字H20243388 | 2024/03/29 | 0.125g(按C16H16N4O8S计) | 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H20243389 | 2024/03/29 | 0.25g(按C16H16N4O8S计 ) | 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 |
| 成都倍特药业股份有限公司 | 成都倍特药业股份有限公司 | 国药准字H20223405 | 2022/06/16 | 0.125g(按C16H16N4O8S计) | 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: 6 distinct approval numbers and 4 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 成都倍特药业股份有限公司 | 国药准字H20223405 | 0.125g(按C16H16N4O8S计) | Category B (乙) | XJ01DCT162X006010102013 | NHSA |
| 河北广祥医药科技有限公司 | 国药准字H20243389 | 0.25g(按C₁₆H₁₆N₄O₈S计) | Category B (乙) | XJ01DCT162X006010102763 | NHSA |
| 山东鲁抗医药股份有限公司 | 国药准字H20010810 | 按C16H16N4O8S计算 0.125g | Category B (乙) | XJ01DCT162X006010104129 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20255837 | 0.125g(按C₁₆H₁₆N₄O₈S计) | Category B (乙) | XJ01DCT162X006010104152 | NHSA |
| 成都倍特药业股份有限公司 | 国药准字H20223405 | 0.125g(按C16H16N4O8S计) | Category B (乙) | XJ01DCT162X006010202013 | NHSA |
| 山东鲁抗医药股份有限公司 | 国药准字H20010810 | 按C16H16N4O8S计算 0.125g | Category B (乙) | XJ01DCT162X006010204129 | NHSA |
| 山东鲁抗医药股份有限公司 | 国药准字H20010810 | 按C16H16N4O8S计算 0.125g | Category B (乙) | XJ01DCT162X006010304129 | NHSA |
| 山东鲁抗医药股份有限公司 | 国药准字H20010810 | 按C16H16N4O8S计算 0.125g | Category B (乙) | XJ01DCT162X006010404129 | NHSA |
| 山东鲁抗医药股份有限公司 | 国药准字H20010810 | 按C16H16N4O8S计算 0.125g | Category B (乙) | XJ01DCT162X006010504129 | NHSA |
| 山东鲁抗医药股份有限公司 | 国药准字H20010810 | 按C16H16N4O8S计算 0.125g | Category B (乙) | XJ01DCT162X006010604129 | NHSA |
| 山东鲁抗医药股份有限公司 | 国药准字H20010810 | 按C16H16N4O8S计算 0.125g | Category B (乙) | XJ01DCT162X006010704129 | NHSA |
| 山东鲁抗医药股份有限公司 | 国药准字H20010810 | 按C16H16N4O8S计算 0.125g | Category B (乙) | XJ01DCT162X006010804129 | NHSA |
| 山东鲁抗医药股份有限公司 | 国药准字H20010810 | 按C16H16N4O8S计算 0.125g | Category B (乙) | XJ01DCT162X006010904129 | NHSA |
| 河北广祥医药科技有限公司 | 国药准字H20243388 | 0.125g(按C₁₆H₁₆N₄O₈S计) | Category B (乙) | XJ01DCT162X006020102763 | NHSA |
| 瑞阳制药股份有限公司 | 国药准字H20255836 | 0.25g(按C₁₆H₁₆N₄O₈S计) | Category B (乙) | XJ01DCT162X006020104152 | 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: 5 filings and 3 distinct first applicants.
Supplement 2 · Generic 3
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 河北广祥医药科技有限公司;石家庄四药有限公司 | CYHB2601351 | Supplement | 2026/07/15 | Not stated by source | CDE |
| 河北广祥医药科技有限公司;石家庄四药有限公司 | CYHB2601350 | Supplement | 2026/07/15 | Not stated by source | CDE |
| 福安药业集团庆余堂制药有限公司 | CYHS2601293 | Generic | 2026/06/03 | Not stated by source | CDE |
| 华北制药河北华民药业有限责任公司 | CYHS2600200 | Generic | 2026/01/16 | Not stated by source | CDE |
| 华北制药河北华民药业有限责任公司 | CYHS2600199 | Generic | 2026/01/16 | Not stated by source | CDE |
Loaded records: 3 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 福安药业集团庆余堂制药有限公司 | CYHS2601293 | Generic | 2026/06/03 | Not stated by source | CDE |
| 华北制药河北华民药业有限责任公司 | CYHS2600200 | Generic | 2026/01/16 | Not stated by source | CDE |
| 华北制药河北华民药业有限责任公司 | CYHS2600199 | Generic | 2026/01/16 | Not stated by source | CDE |
Non-component matches: 10 companies with A status and 3 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 |
|---|---|---|---|---|---|---|
| 头孢呋辛酯 | 珠海保税区丽珠合成制药有限公司 | Y20250000232 | I | Exact ingredient | 2025/03/21 | CDE |
| 头孢呋辛酯 | 河南立诺制药有限公司 | Y20250000070 | A | Exact ingredient | 2026/09/08 | CDE |
| 头孢呋辛酯 | 浙江东盈药业有限公司 | Y20230000471 | A | Exact ingredient | 2025/12/09 | CDE |
| 头孢呋辛酯 | Apitoria Pharma Private Limited | Y20220000307 | A | Exact ingredient | 2024/12/31 | CDE |
| 头孢呋辛酯 | Nectar Lifesciences Ltd. | Y20190021187 | I | Exact ingredient | 2020/05/29 | CDE |
| 头孢呋辛酯 | Aurobindo Pharma Limited | Y20190009189 | A | Exact ingredient | — | CDE |
| 头孢呋辛酯 | 广东立国制药有限公司 | Y20190008815 | A | Exact ingredient | 2025/06/14 | CDE |
| 头孢呋辛酯 | 安徽丰原利康制药有限公司 | Y20190006721 | A | Exact ingredient | 2022/10/27 | CDE |
| 头孢呋辛酯 | 华北制药河北华民药业有限责任公司 | Y20190003796 | A | Exact ingredient | 2025/03/20 | CDE |
| 头孢呋辛酯 | 珠海联邦制药股份有限公司 | Y20190001513 | A | Exact ingredient | 2024/08/29 | CDE |
| 头孢呋辛酯 | 浙江国邦药业有限公司 | Y20170000819 | A | Exact ingredient | 2022/10/20 | CDE |
| 头孢呋辛酯 | 苏州盛达药业有限公司 | Y20170000243 | A | Exact ingredient | 2023/03/24 | CDE |
| 头孢呋辛酯 | 苏州致君万庆药业有限公司 | Y20170000059 | I | Exact ingredient | 2023/12/11 | 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.
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.
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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