Monthly
US$200
Billed every month
Sodium Ibandronate Injection(伊班膦酸钠注射液)
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 1 applicationNotification delivery: 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 holders9View records ↓
Under-review filings4View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers26View records ↓
API companies with A status12View records ↓
Chemical-drug catalogue
Loaded records: 9 holders; 8 in the quality-and-efficacy consistency-evaluation category, and 0 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 |
|---|---|---|---|---|---|---|
| 石家庄凯达生物工程有限公司 | 石家庄凯达生物工程有限公司 | 国药准字H20010432 | 2025/12/11 | 1ml：1mg（按C9H23NO7P2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 |
| 石家庄凯达生物工程有限公司 | 石家庄凯达生物工程有限公司 | 国药准字H20050669 | 2025/12/11 | 2ml：2mg（按C9H23NO7P2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 |
| 天津红日药业股份有限公司 | 哈尔滨三联药业股份有限公司 | 国药准字H20247304 | 2024/12/05 | 2ml:2mg（按C9H23NO7P2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 |
| 天津红日药业股份有限公司 | 哈尔滨三联药业股份有限公司 | 国药准字H20203187 | 2024/12/05 | 1ml:1mg（按C9H23NO7P2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 |
| 河北仁合益康药业有限公司 | 河北仁合益康药业有限公司 | 国药准字H20193357 | 2023/09/28 | 6ml:6mg（按C9H23NO7P2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 |
| 河北仁合益康药业有限公司 | 河北仁合益康药业有限公司 | 国药准字H20193355 | 2023/09/28 | 2ml：2mg（按C9H23NO7P2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 |
| 福州基石医药科技有限公司 | 福州基石医药科技有限公司 | 国药准字H20237109 | 2023/09/11 | 1ml∶1mg(按C9H23NO7P2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 |
| 福州基石医药科技有限公司 | 福州基石医药科技有限公司 | 国药准字H20203138 | 2023/09/11 | 2ml∶2mg(按C9H23NO7P2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 |
| 四川美大康佳乐药业有限公司 | 四川美大康佳乐药业有限公司 | 国药准字H20133076 | 2022/06/17 | 1ml:1mg(按C9H23NO7P2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 |
| 四川美大康佳乐药业有限公司 | 四川美大康佳乐药业有限公司 | 国药准字H20133077 | 2022/06/17 | 2ml:2mg（按C9H23NO7P2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 |
| 南京恒生制药有限公司 | 南京恒生制药有限公司 | 国药准字H20217088 | 2021/10/15 | 6ml:6mg（按C9H23NO7P2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 |
| 南京恒生制药有限公司 | 南京恒生制药有限公司 | 国药准字H20080347 | 2021/10/15 | 2ml:2mg（按C9H23NO7P2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 |
| 南京恒生制药有限公司 | 南京恒生制药有限公司 | 国药准字H20010379 | 2021/10/15 | 1ml:1mg（按C9H23NO7P2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 |
| 齐鲁制药有限公司 | 齐鲁制药有限公司 | 国药准字H20183019 | 2021/07/30 | 2ml:2mg（按C9H23NO7P2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 |
| 齐鲁制药有限公司 | 齐鲁制药有限公司 | 国药准字H20183018 | 2021/07/30 | 1ml:1mg（按C9H23NO7P2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 |
| 齐鲁制药有限公司 | 齐鲁制药有限公司 | 国药准字H20183020 | 2021/07/30 | 3ml:3mg（按C9H23NO7P2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 |
| 成都苑东生物制药股份有限公司 | 成都苑东生物制药股份有限公司 | 国药准字H20123095 | 2021/03/18 | 6ml:6mg（按C9H23NO7P2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 |
| 成都苑东生物制药股份有限公司 | 成都苑东生物制药股份有限公司 | 国药准字H20123094 | 2021/03/18 | 2ml:2mg（按C9H23NO7P2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 |
| 成都苑东生物制药股份有限公司 | 成都苑东生物制药股份有限公司 | 国药准字H20123090 | 2021/03/18 | 1ml:1mg（按C9H23NO7P2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 |
| Atnahs Pharma UK Limited | Roche Diagnostics GmbH | H20150097 | 2005/08/26 | 6ml:6mg（以伊班膦酸计） | Imported originator drug (进口原研药品) | CDE |
| Atnahs Pharma UK Limited | Roche Diagnostics GmbH | H20150096 | 2002/06/14 | 2ml:2mg（以伊班膦酸计） | 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: 26 distinct approval numbers and 10 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 天津红日药业股份有限公司 | 国药准字H20203187 | 1ml:1mg(按C₉H₂₃NO₇P₂ 计) | Category B (乙) | XM05BAY053B002010100864 | NHSA |
| 南京恒生制药有限公司 | 国药准字H20010379 | 1ml:1mg(按C₉H₂₃NO₇P₂计) | Category B (乙) | XM05BAY053B002010101565 | NHSA |
| 成都苑东生物制药股份有限公司 | 国药准字H20194059 | 3ml:3mg(以伊班膦酸计) | Category B (乙) | XM05BAY053B002010102181 | NHSA |
| 四川美大康佳乐药业有限公司 | 国药准字H20133076 | 1ml:1mg(按C₉H₂₃NO₇P₂ 计) | Category B (乙) | XM05BAY053B002010102189 | NHSA |
| 石家庄凯达生物工程有限公司 | 国药准字H20010432 | 1ml:1mg(以伊班膦酸计) | Category B (乙) | XM05BAY053B002010102679 | NHSA |
| 福州基石医药科技有限公司 | 国药准字H20203138 | 2ml∶2mg(按C₉H₂₃NO₇P₂计) | Category B (乙) | XM05BAY053B002010104777 | NHSA |
| 河北仁合益康药业有限公司 | 国药准字H20193355 | 2ml:2mg(按C₉H₂₃NO₇P₂计) | Category B (乙) | XM05BAY053B002010110349 | NHSA |
| ATNAHS PHARMA UK LIMITED | 国药准字HJ20150096 | 2ml:2mg(以伊班膦酸计) | Category B (乙) | XM05BAY053B002010179436 | NHSA |
| 福州基石医药科技有限公司 | 国药准字H20237109 | 1ml∶1mg(按C₉H₂₃NO₇P₂计) | Category B (乙) | XM05BAY053B002010184338 | NHSA |
| 南京恒生制药有限公司 | 国药准字H20010379 | 1ml:1mg(按C₉H₂₃NO₇P₂计) | Category B (乙) | XM05BAY053B002010201565 | NHSA |
| 四川美大康佳乐药业有限公司 | 国药准字H20133076 | 1ml:1mg(按C₉H₂₃NO₇P₂ 计) | Category B (乙) | XM05BAY053B002010202189 | NHSA |
| 石家庄凯达生物工程有限公司 | 国药准字H20010432 | 1ml:1mg(以伊班膦酸计) | Category B (乙) | XM05BAY053B002010202679 | NHSA |
| 齐鲁制药有限公司 | 国药准字H20183018 | 1ml:1mg(以C9H23NO7P2计) | Category B (乙) | XM05BAY053B002010204021 | NHSA |
| 河北仁合益康药业有限公司 | 国药准字H20193357 | 6ml:6mg(按C₉H₂₃NO₇P₂计) | Category B (乙) | XM05BAY053B002010210349 | NHSA |
| 齐鲁制药有限公司 | 国药准字H20183018 | 1ml:1mg(以C9H23NO7P2计) | Category B (乙) | XM05BAY053B002010304021 | NHSA |
| 河北仁合益康药业有限公司 | 国药准字H20193356 | 以C₉H₂₃NO₇P₂计4ml:4mg | Category B (乙) | XM05BAY053B002010310349 | NHSA |
| 天津红日药业股份有限公司 | 国药准字H20247304 | 2ml:2mg(按C₉H₂₃NO₇P₂计) | Category B (乙) | XM05BAY053B002020100864 | NHSA |
| 南京恒生制药有限公司 | 国药准字H20080347 | 2ml:2mg(按C₉H₂₃NO₇P₂计) | Category B (乙) | XM05BAY053B002020101565 | NHSA |
| 成都苑东生物制药股份有限公司 | 国药准字H20194060 | 4ml:4mg(以伊班膦酸计) | Category B (乙) | XM05BAY053B002020102181 | NHSA |
| 四川美大康佳乐药业有限公司 | 国药准字H20133077 | 2ml:2mg(按C₉H₂₃NO₇P₂ 计) | Category B (乙) | XM05BAY053B002020102189 | NHSA |
| 石家庄凯达生物工程有限公司 | 国药准字H20050669 | 2ml:2mg(以伊班膦酸计) | Category B (乙) | XM05BAY053B002020102679 | NHSA |
| 齐鲁制药有限公司 | 国药准字H20183019 | 2ml:2mg(以C9H23NO7P2计) | Category B (乙) | XM05BAY053B002020104021 | NHSA |
| ATNAHS PHARMA UK LIMITED | 国药准字HJ20150097 | 6ml:6mg(以伊班膦酸计) | Category B (乙) | XM05BAY053B002020179436 | NHSA |
| 天津红日药业股份有限公司 | 国药准字H20247304 | 2ml:2mg(按C₉H₂₃NO₇P₂计) | Category B (乙) | XM05BAY053B002020200864 | NHSA |
| 南京恒生制药有限公司 | 国药准字H20080347 | 2ml:2mg(按C₉H₂₃NO₇P₂计) | Category B (乙) | XM05BAY053B002020201565 | NHSA |
| 四川美大康佳乐药业有限公司 | 国药准字H20133077 | 2ml:2mg(按C₉H₂₃NO₇P₂ 计) | Category B (乙) | XM05BAY053B002020202189 | NHSA |
| 天津红日药业股份有限公司 | 国药准字H20203187 | 1ml:1mg(按C₉H₂₃NO₇P₂ 计) | Category B (乙) | XM05BAY053B002030100864 | NHSA |
| 南京恒生制药有限公司 | 国药准字H20217088 | 6ml:6mg(按C9H23NO7P2计) | Category B (乙) | XM05BAY053B002030101565 | NHSA |
| 成都苑东生物制药股份有限公司 | 国药准字H20123090 | 1ml:1mg(按C9H23NO7P2计) | Category B (乙) | XM05BAY053B002030102181 | NHSA |
| 石家庄凯达生物工程有限公司 | 国药准字H20163325 | 4ml:4mg(以伊班膦酸计) | Category B (乙) | XM05BAY053B002030102679 | NHSA |
| 齐鲁制药有限公司 | 国药准字H20183020 | 3ml:3mg(以C9H23NO7P2计) | Category B (乙) | XM05BAY053B002030104021 | NHSA |
| 成都苑东生物制药股份有限公司 | 国药准字H20123090 | 1ml:1mg(按C9H23NO7P2计) | Category B (乙) | XM05BAY053B002030202181 | NHSA |
| 成都苑东生物制药股份有限公司 | 国药准字H20123094 | 2ml:2mg(按C9H23NO7P2计) | Category B (乙) | XM05BAY053B002040102181 | NHSA |
| 石家庄凯达生物工程有限公司 | 国药准字H20163324 | 6ml:6mg(以伊班膦酸计) | Category B (乙) | XM05BAY053B002040102679 | NHSA |
| 成都苑东生物制药股份有限公司 | 国药准字H20123094 | 2ml:2mg(按C9H23NO7P2计) | Category B (乙) | XM05BAY053B002040202181 | NHSA |
| 成都国为生物医药股份有限公司 | 国药准字H20123095 | 6ml:6mg(按C₉H₂₃NO₇P₂计) | Category B (乙) | XM05BAY053B002050102181 | 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: 4 filings and 3 distinct first applicants.
Generic 4
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 河北千康医药科技有限责任公司;山东齐都药业有限公司 | CYHS2602435 | Generic | 2026/09/30 | Not stated by source | CDE |
| 长春澜江医药科技有限公司;吉林振澳制药有限公司 | CYHS2601974 | Generic | 2026/08/12 | Not stated by source | CDE |
| 长春澜江医药科技有限公司;吉林振澳制药有限公司 | CYHS2601973 | Generic | 2026/08/12 | Not stated by source | CDE |
| 山东简道制药有限公司 | CYHS2504027 | Generic | 2025/11/21 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 3 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 河北千康医药科技有限责任公司;山东齐都药业有限公司 | CYHS2602435 | Generic | 2026/09/30 | Not stated by source | CDE |
| 长春澜江医药科技有限公司;吉林振澳制药有限公司 | CYHS2601974 | Generic | 2026/08/12 | Not stated by source | CDE |
| 长春澜江医药科技有限公司;吉林振澳制药有限公司 | CYHS2601973 | Generic | 2026/08/12 | Not stated by source | CDE |
API registrations
Non-component matches: 12 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 |
|---|---|---|---|---|---|---|
| 伊班膦酸钠 | 植恩生物技术股份有限公司 | Y20260000393 | I | Exact ingredient | 2026/06/04 | CDE |
| 伊班膦酸钠 | 远大生命科学（鞍山）有限公司 | Y20250001081 | I | Exact ingredient | 2025/10/28 | CDE |
| 伊班膦酸钠 | 沧州维智达美制药有限公司 | Y20250000109 | I | Exact ingredient | 2025/02/19 | CDE |
| 伊班膦酸钠 | 乐声药业石家庄有限公司 | Y20240000869 | A | Exact ingredient | 2026/04/11 | CDE |
| 伊班膦酸钠 | Maprimed S.A. | Y20240000639 | A | Exact ingredient | 2026/06/21 | CDE |
| 伊班膦酸钠 | Natco Pharma Limited | Y20230001170 | I | Exact ingredient | 2024/04/11 | CDE |
| 伊班膦酸钠 | Fleming Laboratories Limited | Y20230001154 | A | Exact ingredient | 2026/09/08 | CDE |
| 伊班膦酸钠 | 亚宝药业四川制药有限公司 | Y20190007075 | A | Exact ingredient | — | CDE |
| 伊班膦酸钠 | 四川青木制药有限公司 | Y20190006500 | A | Exact ingredient | 2026/05/06 | CDE |
| 伊班膦酸钠 | 乐声药业石家庄有限公司 | Y20190005093 | A | Exact ingredient | 2024/11/07 | CDE |
| 伊班膦酸钠 | 南京恒生制药有限公司 | Y20190003071 | A | Exact ingredient | 2025/02/25 | CDE |
| 伊班膦酸钠 | Aurobindo Pharma Limited | Y20190000127 | I | Exact ingredient | 2019/04/25 | CDE |
| 伊班膦酸钠 | 湖南方盛制药股份有限公司 | Y20170001435 | A | Exact ingredient | 2024/07/02 | CDE |
| 伊班膦酸钠 | 浙江普洛得邦制药有限公司 | Y20170001353 | A | Exact ingredient | 2023/04/24 | CDE |
| 伊班膦酸钠 | Pharmaceutical Works POLPHARMA S.A. | Y20170001228 | I | Exact ingredient | — | CDE |
| 伊班膦酸钠 | 河北创健药业有限公司 | Y20170001216 | A | Exact ingredient | 2024/04/03 | CDE |
| 伊班膦酸钠 | 天津红日药业股份有限公司 | Y20170000515 | A | Exact ingredient | 2025/12/31 | CDE |
| 伊班膦酸钠 | 四川协力制药有限公司 | Y20170000456 | I | Exact ingredient | — | CDE |
| 伊班膦酸钠 | 重庆圣华曦药业股份有限公司 | Y20170000313 | I | Exact ingredient | — | CDE |
| 伊班膦酸钠 | 福建金山准点制药有限公司 | Y20170000163 | A | Exact ingredient | 2025/03/04 | CDE |
| 伊班膦酸钠 | 齐鲁制药有限公司 | Y20170000036 | A | Exact ingredient | 2024/09/03 | 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.
-
2026/10/28Notification delivery
上海旭东海普药业有限公司
CYHS2401865
Fact date: 2026/10/28 (Publication date) · Publication date: 2026/10/28 · Site observation date: 2026/11/03
Notification delivered; the specific outcome remains to be checked.
View source · Table row 7 ↗ -
2026/10/28Notification delivery
上海旭东海普药业有限公司
CYHS2401864
Fact date: 2026/10/28 (Publication date) · Publication date: 2026/10/28 · Site observation date: 2026/11/03
Notification delivered; the specific outcome remains to be checked.
View source · Table row 6 ↗ -
2026/10/28Notification delivery
上海旭东海普药业有限公司
CYHS2401863
Fact date: 2026/10/28 (Publication date) · Publication date: 2026/10/28 · Site observation date: 2026/11/03
Notification delivered; the specific outcome remains to be checked.
View source · Table row 5 ↗ -
2026/09/30Accepted
河北千康医药科技有限责任公司;山东齐都药业有限公司
CYHS2602435
Fact date: 2026/09/30 · 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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