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As of 13 November 2026, for Sodium Ibandronate Injection, 4 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 9 holders.
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.
Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Unverified drug names retain the Chinese source name with a No verified English name marker. Other Chinese free text is not displayed; use the source links or source-name columns in CSV exports.
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 |
|---|---|---|---|---|---|---|
| Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized | Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized | 国药准字H20010432 | 2025/12/11 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized | Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized | 国药准字H20050669 | 2025/12/11 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Tianjin Hong Ri Pharma Co., Ltd. romanized | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20247304 | 2024/12/05 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Tianjin Hong Ri Pharma Co., Ltd. romanized | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20203187 | 2024/12/05 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Hebei Ren He Yi Kang Pharma Co., Ltd. romanized | Hebei Ren He Yi Kang Pharma Co., Ltd. romanized | 国药准字H20193357 | 2023/09/28 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Hebei Ren He Yi Kang Pharma Co., Ltd. romanized | Hebei Ren He Yi Kang Pharma Co., Ltd. romanized | 国药准字H20193355 | 2023/09/28 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized | Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20237109 | 2023/09/11 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized | Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20203138 | 2023/09/11 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized | Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized | 国药准字H20133076 | 2022/06/17 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized | Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized | 国药准字H20133077 | 2022/06/17 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized | Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20217088 | 2021/10/15 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized | Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20080347 | 2021/10/15 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized | Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20010379 | 2021/10/15 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. | 国药准字H20183019 | 2021/07/30 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. | 国药准字H20183018 | 2021/07/30 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. | 国药准字H20183020 | 2021/07/30 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20123095 | 2021/03/18 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20123094 | 2021/03/18 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20123090 | 2021/03/18 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Atnahs Pharma UK Limited | Roche Diagnostics GmbH | H20150097 | 2005/08/26 | See source | Imported originator drug | CDE |
| Atnahs Pharma UK Limited | Roche Diagnostics GmbH | H20150096 | 2002/06/14 | See source | Imported originator drug | 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 |
|---|---|---|---|---|---|
| Tianjin Hong Ri Pharma Co., Ltd. romanized | 国药准字H20203187 | See source | Category B | XM05BAY053B002010100864 | NHSA |
| Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20010379 | See source | Category B | XM05BAY053B002010101565 | NHSA |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20194059 | See source | Category B | XM05BAY053B002010102181 | NHSA |
| Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized | 国药准字H20133076 | See source | Category B | XM05BAY053B002010102189 | NHSA |
| Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized | 国药准字H20010432 | See source | Category B | XM05BAY053B002010102679 | NHSA |
| Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20203138 | See source | Category B | XM05BAY053B002010104777 | NHSA |
| Hebei Ren He Yi Kang Pharma Co., Ltd. romanized | 国药准字H20193355 | See source | Category B | XM05BAY053B002010110349 | NHSA |
| ATNAHS PHARMA UK LIMITED | 国药准字HJ20150096 | See source | Category B | XM05BAY053B002010179436 | NHSA |
| Fuzhou Ji Shi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20237109 | See source | Category B | XM05BAY053B002010184338 | NHSA |
| Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20010379 | See source | Category B | XM05BAY053B002010201565 | NHSA |
| Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized | 国药准字H20133076 | See source | Category B | XM05BAY053B002010202189 | NHSA |
| Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized | 国药准字H20010432 | See source | Category B | XM05BAY053B002010202679 | NHSA |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20183018 | See source | Category B | XM05BAY053B002010204021 | NHSA |
| Hebei Ren He Yi Kang Pharma Co., Ltd. romanized | 国药准字H20193357 | See source | Category B | XM05BAY053B002010210349 | NHSA |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20183018 | See source | Category B | XM05BAY053B002010304021 | NHSA |
| Hebei Ren He Yi Kang Pharma Co., Ltd. romanized | 国药准字H20193356 | See source | Category B | XM05BAY053B002010310349 | NHSA |
| Tianjin Hong Ri Pharma Co., Ltd. romanized | 国药准字H20247304 | See source | Category B | XM05BAY053B002020100864 | NHSA |
| Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20080347 | See source | Category B | XM05BAY053B002020101565 | NHSA |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20194060 | See source | Category B | XM05BAY053B002020102181 | NHSA |
| Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized | 国药准字H20133077 | See source | Category B | XM05BAY053B002020102189 | NHSA |
| Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized | 国药准字H20050669 | See source | Category B | XM05BAY053B002020102679 | NHSA |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20183019 | See source | Category B | XM05BAY053B002020104021 | NHSA |
| ATNAHS PHARMA UK LIMITED | 国药准字HJ20150097 | See source | Category B | XM05BAY053B002020179436 | NHSA |
| Tianjin Hong Ri Pharma Co., Ltd. romanized | 国药准字H20247304 | See source | Category B | XM05BAY053B002020200864 | NHSA |
| Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20080347 | See source | Category B | XM05BAY053B002020201565 | NHSA |
| Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized | 国药准字H20133077 | See source | Category B | XM05BAY053B002020202189 | NHSA |
| Tianjin Hong Ri Pharma Co., Ltd. romanized | 国药准字H20203187 | See source | Category B | XM05BAY053B002030100864 | NHSA |
| Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20217088 | See source | Category B | XM05BAY053B002030101565 | NHSA |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20123090 | See source | Category B | XM05BAY053B002030102181 | NHSA |
| Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized | 国药准字H20163325 | See source | Category B | XM05BAY053B002030102679 | NHSA |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20183020 | See source | Category B | XM05BAY053B002030104021 | NHSA |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20123090 | See source | Category B | XM05BAY053B002030202181 | NHSA |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20123094 | See source | Category B | XM05BAY053B002040102181 | NHSA |
| Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized | 国药准字H20163324 | See source | Category B | XM05BAY053B002040102679 | NHSA |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20123094 | See source | Category B | XM05BAY053B002040202181 | NHSA |
| Chengdu Guo Wei Biopharmaceuticals Co., Ltd. romanized | 国药准字H20123095 | See source | Category B | 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 |
|---|---|---|---|---|---|
| Hebei Qian Kang Pharmaceuticals Technology Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd. | CYHS2602435 | Generic | 2026/09/30 | Not stated by source | CDE |
| Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized | CYHS2601974 | Generic | 2026/08/12 | Not stated by source | CDE |
| Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized | CYHS2601973 | Generic | 2026/08/12 | Not stated by source | CDE |
| Shandong Jian Dao Pharmaceutical Co., Ltd. romanized | 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 |
|---|---|---|---|---|---|
| Hebei Qian Kang Pharmaceuticals Technology Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd. | CYHS2602435 | Generic | 2026/09/30 | Not stated by source | CDE |
| Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized | CYHS2601974 | Generic | 2026/08/12 | Not stated by source | CDE |
| Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Jilin Zhen Ao Pharmaceutical Co., Ltd. romanized | 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 · No verified English name | Zhi En Bio Technology Co., Ltd. romanized | Y20260000393 | I | Exact ingredient | 2026/06/04 | CDE |
| 伊班膦酸钠 · No verified English name | Yuan Da Sheng Ming Ke Xue (An Shan) Co., Ltd. romanized | Y20250001081 | I | Exact ingredient | 2025/10/28 | CDE |
| 伊班膦酸钠 · No verified English name | Cang Zhou Wei Zhi Da Mei Pharmaceutical Co., Ltd. romanized | Y20250000109 | I | Exact ingredient | 2025/02/19 | CDE |
| 伊班膦酸钠 · No verified English name | Le Sheng Pharma Shijiazhuang Co., Ltd. romanized | Y20240000869 | A | Exact ingredient | 2026/04/11 | CDE |
| 伊班膦酸钠 · No verified English name | Maprimed S.A. | Y20240000639 | A | Exact ingredient | 2026/06/21 | CDE |
| 伊班膦酸钠 · No verified English name | Natco Pharma Limited | Y20230001170 | I | Exact ingredient | 2024/04/11 | CDE |
| 伊班膦酸钠 · No verified English name | Fleming Laboratories Limited | Y20230001154 | A | Exact ingredient | 2026/09/08 | CDE |
| 伊班膦酸钠 · No verified English name | Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized | Y20190007075 | A | Exact ingredient | — | CDE |
| 伊班膦酸钠 · No verified English name | Sichuan Qing Mu Pharmaceutical Co., Ltd. romanized | Y20190006500 | A | Exact ingredient | 2026/05/06 | CDE |
| 伊班膦酸钠 · No verified English name | Le Sheng Pharma Shijiazhuang Co., Ltd. romanized | Y20190005093 | A | Exact ingredient | 2024/11/07 | CDE |
| 伊班膦酸钠 · No verified English name | Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized | Y20190003071 | A | Exact ingredient | 2025/02/25 | CDE |
| 伊班膦酸钠 · No verified English name | Aurobindo Pharma Limited | Y20190000127 | I | Exact ingredient | 2019/04/25 | CDE |
| 伊班膦酸钠 · No verified English name | Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | Y20170001435 | A | Exact ingredient | 2024/07/02 | CDE |
| 伊班膦酸钠 · No verified English name | Zhejiang Pu Luo De Bang Pharmaceutical Co., Ltd. romanized | Y20170001353 | A | Exact ingredient | 2023/04/24 | CDE |
| 伊班膦酸钠 · No verified English name | Pharmaceutical Works POLPHARMA S.A. | Y20170001228 | I | Exact ingredient | — | CDE |
| 伊班膦酸钠 · No verified English name | Hebei Chuang Jian Pharma Co., Ltd. romanized | Y20170001216 | A | Exact ingredient | 2024/04/03 | CDE |
| 伊班膦酸钠 · No verified English name | Tianjin Hong Ri Pharma Co., Ltd. romanized | Y20170000515 | A | Exact ingredient | 2025/12/31 | CDE |
| 伊班膦酸钠 · No verified English name | Sichuan Xie Li Pharmaceutical Co., Ltd. romanized | Y20170000456 | I | Exact ingredient | — | CDE |
| 伊班膦酸钠 · No verified English name | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | Y20170000313 | I | Exact ingredient | — | CDE |
| 伊班膦酸钠 · No verified English name | Fujian Jin Shan Zhun Dian Pharmaceutical Co., Ltd. romanized | Y20170000163 | A | Exact ingredient | 2025/03/04 | CDE |
| 伊班膦酸钠 · No verified English name | Qilu Pharmaceutical Co., Ltd. | 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: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.
-
2026/10/28Notification delivery
Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized
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
Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized
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
Shanghai Xu Dong Hai Pu Pharma Co., Ltd. romanized
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
Hebei Qian Kang Pharmaceuticals Technology Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd.
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: 2026/11/13 06:42
- Chemical-drug catalogue
- Last successful update: 2026/11/13 06:39
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: 2026/11/13 06:41
- 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: 2026/11/12 18:32 · Current coverage may be incomplete
First index-page publication dates: 2026-10-29 to 2026-11-13; 2 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/13 08:09 · 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: 7/30; discovered pending details: 13. 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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