Monthly
US$200
Billed every month
Promethazine Hydrochloride Injection(盐酸异丙嗪注射液)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 2 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 holders5View records ↓
Under-review filings11View records ↓
This year’s generic filers5View records ↓
NHSA approval numbers24View records ↓
API companies with A status8View records ↓
Chemical-drug catalogue
Loaded records: 5 holders; 3 in the quality-and-efficacy consistency-evaluation category, and 2 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 |
|---|---|---|---|---|---|---|
| 石家庄荣雾迪医药科技有限公司 | 亚邦医药股份有限公司 | 国药准字H20265949 | 2026/09/15 | 1ml：25mg | 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 |
| 上海禾丰制药有限公司 | 上海禾丰制药有限公司 | 国药准字H31021490 | 2026/08/11 | 1ml∶25mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 扬州中宝药业股份有限公司 | 扬州中宝药业股份有限公司 | 国药准字H20256394 | 2025/12/22 | 2ml:50mg | 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 |
| 遂成药业股份有限公司 | 遂成药业股份有限公司 | 国药准字H41021181 | 2025/08/07 | 2ml：50mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | CDE |
| 丹东医创药业有限责任公司 | 丹东医创药业有限责任公司 | 国药准字H21020328 | 2026/09/24 | 2ml：50mg | Drug that passed quality-and-efficacy consistency evaluation (通过质量和疗效一致性评价的药品) | 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 20 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 广东邦民制药厂有限公司 | 国药准字H44021728 | 2ml:50mg | Category A (甲) | XR06ADY136B002010100267 | NHSA |
| 广东南国药业有限公司 | 国药准字H44022504 | 2ml:50mg | Category A (甲) | XR06ADY136B002010100315 | NHSA |
| 上海禾丰制药有限公司 | 国药准字H31021490 | 1ml∶25mg | Category A (甲) | XR06ADY136B002010100673 | NHSA |
| 津药和平(天津)制药有限公司 | 国药准字H12020969 | 2ml:50mg | Category A (甲) | XR06ADY136B002010100874 | NHSA |
| 西南药业股份有限公司 | 国药准字H50020140 | 2ml:50mg | Category A (甲) | XR06ADY136B002010100978 | NHSA |
| 丹东医创药业有限责任公司 | 国药准字H21020328 | 2ml:50mg | Category A (甲) | XR06ADY136B002010101157 | NHSA |
| 亚邦医药股份有限公司 | 国药准字H32021437 | 1ml:25mg | Category A (甲) | XR06ADY136B002010101511 | NHSA |
| 湖北科伦药业有限公司 | 国药准字H42021178 | 2ml:50mg | Category A (甲) | XR06ADY136B002010101871 | NHSA |
| 武汉福星生物药业有限公司 | 国药准字H42023002 | 2ml:50mg | Category A (甲) | XR06ADY136B002010101962 | NHSA |
| 成都第一制药有限公司 | 国药准字H51023000 | 2ml:50mg | Category A (甲) | XR06ADY136B002010102065 | NHSA |
| 西安风华药业有限公司 | 国药准字H61021122 | 2ml:50mg | Category A (甲) | XR06ADY136B002010102420 | NHSA |
| 西安迪赛生物药业有限责任公司 | 国药准字H61021138 | 2ml:50mg | Category A (甲) | XR06ADY136B002010102470 | NHSA |
| 河南福森药业有限公司 | 国药准字H41021097 | 2ml:50mg | Category A (甲) | XR06ADY136B002010103020 | NHSA |
| 天方药业有限公司 | 国药准字H41020482 | 2ml:50mg | Category A (甲) | XR06ADY136B002010103098 | NHSA |
| 遂成药业股份有限公司 | 国药准字H41021181 | 2ml:50mg | Category A (甲) | XR06ADY136B002010103204 | NHSA |
| 中嘉生物科技(湖北省)有限公司 | 国药准字H20053946 | 2ml:50mg | Category A (甲) | XR06ADY136B002010103377 | NHSA |
| 通化华夏药业有限责任公司 | 国药准字H20053042 | 2ml:50mg | Category A (甲) | XR06ADY136B002010103556 | NHSA |
| 酒泉大得利制药股份有限公司 | 国药准字H62020337 | 2ml:50mg | Category A (甲) | XR06ADY136B002010105868 | NHSA |
| 扬州中宝药业股份有限公司 | 国药准字H20256394 | 2ml:50mg | Category A (甲) | XR06ADY136B002010181161 | NHSA |
| 江西人可医药科技有限公司 | 国药准字H20266073 | 1ml:25mg | Category A (甲) | XR06ADY136B002010184300 | NHSA |
| 广东南国药业有限公司 | 国药准字H44022504 | 2ml:50mg | Category A (甲) | XR06ADY136B002010200315 | NHSA |
| 上海禾丰制药有限公司 | 国药准字H31021490 | 1ml∶25mg | Category A (甲) | XR06ADY136B002010200673 | NHSA |
| 津药和平(天津)制药有限公司 | 国药准字H12020969 | 2ml:50mg | Category A (甲) | XR06ADY136B002010200874 | NHSA |
| 西南药业股份有限公司 | 国药准字H50020140 | 2ml:50mg | Category A (甲) | XR06ADY136B002010200978 | NHSA |
| 丹东医创药业有限责任公司 | 国药准字H21020328 | 2ml:50mg | Category A (甲) | XR06ADY136B002010201157 | NHSA |
| 亚邦医药股份有限公司 | 国药准字H32021437 | 1ml:25mg | Category A (甲) | XR06ADY136B002010201511 | NHSA |
| 湖北科伦药业有限公司 | 国药准字H42021178 | 2ml:50mg | Category A (甲) | XR06ADY136B002010201871 | NHSA |
| 武汉福星生物药业有限公司 | 国药准字H42023002 | 2ml:50mg | Category A (甲) | XR06ADY136B002010201962 | NHSA |
| 河南福森药业有限公司 | 国药准字H41021097 | 2ml:50mg | Category A (甲) | XR06ADY136B002010203020 | NHSA |
| 天方药业有限公司 | 国药准字H41020482 | 2ml:50mg | Category A (甲) | XR06ADY136B002010203098 | NHSA |
| 遂成药业股份有限公司 | 国药准字H41021181 | 2ml:50mg | Category A (甲) | XR06ADY136B002010203204 | NHSA |
| 中嘉生物科技(湖北省)有限公司 | 国药准字H20053946 | 2ml:50mg | Category A (甲) | XR06ADY136B002010203377 | NHSA |
| 酒泉大得利制药股份有限公司 | 国药准字H62020337 | 2ml:50mg | Category A (甲) | XR06ADY136B002010205868 | NHSA |
| 上海禾丰制药有限公司 | 国药准字H31022033 | 2ml∶50mg | Category A (甲) | XR06ADY136B002020100673 | NHSA |
| 西南药业股份有限公司 | 国药准字H50021802 | 1ml:25mg | Category A (甲) | XR06ADY136B002020100978 | NHSA |
| 亚邦医药股份有限公司 | 国药准字H32021438 | 2ml:50mg | Category A (甲) | XR06ADY136B002020101511 | NHSA |
| 江西人可医药科技有限公司 | 国药准字H20266074 | 2ml:50mg | Category A (甲) | XR06ADY136B002020184300 | NHSA |
| 上海禾丰制药有限公司 | 国药准字H31022033 | 2ml∶50mg | Category A (甲) | XR06ADY136B002020200673 | NHSA |
| 西南药业股份有限公司 | 国药准字H50021802 | 1ml:25mg | Category A (甲) | XR06ADY136B002020200978 | NHSA |
| 亚邦医药股份有限公司 | 国药准字H32021438 | 2ml:50mg | Category A (甲) | XR06ADY136B002020201511 | 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: 11 filings and 6 distinct first applicants.
Generic 11
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江西科为制药有限公司;河北智同生物制药股份有限公司 | CYHS2602131 | Generic | 2026/08/26 | Not stated by source | CDE |
| 江西科为制药有限公司;河北智同生物制药股份有限公司 | CYHS2602130 | Generic | 2026/08/26 | Not stated by source | CDE |
| 河北桥洲医药科技有限公司;山西诺成制药有限公司 | CYHS2601621 | Generic | 2026/07/07 | Not stated by source | CDE |
| 亚宝药业集团股份有限公司 | CYHS2601244 | Generic | 2026/06/01 | Not stated by source | CDE |
| 亚宝药业集团股份有限公司 | CYHS2601243 | Generic | 2026/06/01 | Not stated by source | CDE |
| 恒衍生物医药技术（厦门）有限公司;福州基石医药科技有限公司 | CYHS2600442 | Generic | 2026/02/11 | Not stated by source | CDE |
| 恒衍生物医药技术（厦门）有限公司;福州基石医药科技有限公司 | CYHS2600441 | Generic | 2026/02/11 | Not stated by source | CDE |
| 康普药业股份有限公司 | CYHS2600044 | Generic | 2026/01/06 | Not stated by source | CDE |
| 康普药业股份有限公司 | CYHS2600043 | Generic | 2026/01/06 | Not stated by source | CDE |
| 成都瑞尔医药科技有限公司;峨眉山通惠制药有限公司 | CYHS2503753 | Generic | 2025/10/21 | Not stated by source | CDE |
| 成都瑞尔医药科技有限公司;峨眉山通惠制药有限公司 | CYHS2503752 | Generic | 2025/10/21 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 9 filings and 5 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江西科为制药有限公司;河北智同生物制药股份有限公司 | CYHS2602131 | Generic | 2026/08/26 | Not stated by source | CDE |
| 江西科为制药有限公司;河北智同生物制药股份有限公司 | CYHS2602130 | Generic | 2026/08/26 | Not stated by source | CDE |
| 河北桥洲医药科技有限公司;山西诺成制药有限公司 | CYHS2601621 | Generic | 2026/07/07 | Not stated by source | CDE |
| 亚宝药业集团股份有限公司 | CYHS2601244 | Generic | 2026/06/01 | Not stated by source | CDE |
| 亚宝药业集团股份有限公司 | CYHS2601243 | Generic | 2026/06/01 | Not stated by source | CDE |
| 恒衍生物医药技术（厦门）有限公司;福州基石医药科技有限公司 | CYHS2600442 | Generic | 2026/02/11 | Not stated by source | CDE |
| 恒衍生物医药技术（厦门）有限公司;福州基石医药科技有限公司 | CYHS2600441 | Generic | 2026/02/11 | Not stated by source | CDE |
| 康普药业股份有限公司 | CYHS2600044 | Generic | 2026/01/06 | Not stated by source | CDE |
| 康普药业股份有限公司 | CYHS2600043 | Generic | 2026/01/06 | Not stated by source | CDE |
API registrations
Non-component matches: 8 companies with A status and 8 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 |
|---|---|---|---|---|---|---|
| 盐酸异丙嗪 | 辽源市银鹰制药有限责任公司 | Y20250001256 | I | Exact ingredient | 2025/12/03 | CDE |
| 盐酸异丙嗪 | 康普药业股份有限公司 | Y20250001052 | I | Exact ingredient | 2025/10/15 | CDE |
| 盐酸异丙嗪 | 南通常佑药业科技有限公司 | Y20250001039 | I | Exact ingredient | 2025/10/11 | CDE |
| 盐酸异丙嗪 | 白云山东泰商丘药业有限公司 | Y20250000833 | I | Exact ingredient | 2025/08/18 | CDE |
| 盐酸异丙嗪 | 河南优凯制药有限公司 | Y20250000406 | I | Exact ingredient | 2025/05/26 | CDE |
| 盐酸异丙嗪 | 遂成药业股份有限公司 | Y20250000312 | A | Exact ingredient | 2026/10/30 | CDE |
| 盐酸异丙嗪 | 河北华晨药业集团有限公司 | Y20250000138 | A | Exact ingredient | 2026/11/04 | CDE |
| 盐酸异丙嗪 | 云鹏医药集团有限公司 | Y20250000134 | A | Exact ingredient | 2026/06/24 | CDE |
| 盐酸异丙嗪 | EGIS PHARMACEUTICALS PLC | Y20200001368 | I | Exact ingredient | 2023/07/03 | CDE |
| 盐酸异丙嗪 | 东港市宏达制药有限公司 | Y20190009610 | A | Exact ingredient | 2025/04/15 | CDE |
| 盐酸异丙嗪 | 辽源市迪康药业有限责任公司 | Y20190005133 | A | Exact ingredient | 2025/05/07 | CDE |
| 盐酸异丙嗪 | 常州康普药业有限公司 | Y20190004404 | A | Exact ingredient | 2025/04/17 | CDE |
| 盐酸异丙嗪 | 丹东医创药业有限责任公司 | Y20190003815 | A | Exact ingredient | 2025/08/29 | CDE |
| 盐酸异丙嗪 | 东港市宏达制药有限公司 | Y20180000801 | I | Exact ingredient | 2018/07/25 | CDE |
| 盐酸异丙嗪 | Harika Drugs Private Limited | Y20170001462 | I | Exact ingredient | — | CDE |
| 盐酸异丙嗪 | 亚宝药业集团股份有限公司 | Y20170000888 | A | Exact ingredient | 2024/07/06 | 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.
-
2026/08/26Accepted
江西科为制药有限公司;河北智同生物制药股份有限公司
CYHS2602131
Fact date: 2026/08/26 · Site observation date: 2026/10/22
View source ↗ -
2026/08/26Accepted
江西科为制药有限公司;河北智同生物制药股份有限公司
CYHS2602130
Fact date: 2026/08/26 · 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.
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