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Sign in to subscribeAlendronate Sodium Oral Solution
As of 13 November 2026, for Alendronate Sodium Oral Solution, 7 applications are listed as under review at China's CDE; 4 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 0 holders.
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.
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 holders0View records ↓
Under-review filings7View records ↓
This year’s generic filers4View records ↓
NHSA approval numbers11View records ↓
API companies with A status11View records ↓
Chemical-drug catalogue
Loaded records: 0 holders; 0 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 |
|---|---|---|---|---|---|---|
| No matching records were found in the currently loaded source data; coverage dates are listed below. | ||||||
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: 11 distinct approval numbers and 11 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | 国药准字H20263255 | See source | Not stated by source | XM05BAA029X001010101012 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20255791 | See source | Not stated by source | XM05BAA029X001010104187 | NHSA |
| Wuhan Hua Er Bio Technology Co., Ltd. romanized | 国药准字H20263732 | See source | Not stated by source | XM05BAA029X001010106652 | NHSA |
| Hebei Ren He Yi Kang Pharma Co., Ltd. romanized | 国药准字H20265452 | See source | Not stated by source | XM05BAA029X001010110349 | NHSA |
| Qin Huang Dao Ai Hui Pharma Co., Ltd. romanized | 国药准字H20255508 | See source | Not stated by source | XM05BAA029X001010183136 | NHSA |
| Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20263425 | See source | Not stated by source | XM05BAA029X001010183686 | NHSA |
| Hunan Pu Dao Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255909 | See source | Not stated by source | XM05BAA029X001010183849 | NHSA |
| Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255910 | See source | Not stated by source | XM05BAA029X001010183864 | NHSA |
| Zhuhai Bei Shan Bio Technology Co., Ltd. romanized | 国药准字H20263672 | See source | Not stated by source | XM05BAA029X001010184470 | NHSA |
| Hubei Xin Ze Fei Pharma Co., Ltd. romanized | 国药准字H20264488 | See source | Not stated by source | XM05BAA029X001010184522 | NHSA |
| Hainan Si Da Pharmaceutical Co., Ltd. romanized | 国药准字H20265874 | See source | Not stated by source | XM05BAA029X001010105816 | 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: 7 filings and 7 distinct first applicants.
Generic 7
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Beijing Hai Jing Biopharmaceuticals Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized | CYHS2600916 | Generic | 2026/04/22 | Not stated by source | CDE |
| Beijing SL Pharmaceutical Co., Ltd. | CYHS2600709 | Generic | 2026/03/24 | Not stated by source | CDE |
| Shaanxi Xin Feng Hua Bio Technology Co., Ltd. romanized; Shaanxi Han Jiang Pharma Group Co., Ltd. romanized | CYHS2504172 | Generic | 2025/12/05 | Not stated by source | CDE |
| Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CYHS2502869 | Generic | 2025/08/08 | Not stated by source | CDE |
| Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized | CYHS2501120 | Generic | 2025/03/20 | Not stated by source | CDE |
| Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized | CYHS2602600 | Generic | 2026/10/22 | Not stated by source | CDE |
| Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized | CYHS2602641 | Generic | 2026/10/29 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 4 filings and 4 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Beijing Hai Jing Biopharmaceuticals Technology Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized | CYHS2600916 | Generic | 2026/04/22 | Not stated by source | CDE |
| Beijing SL Pharmaceutical Co., Ltd. | CYHS2600709 | Generic | 2026/03/24 | Not stated by source | CDE |
| Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized | CYHS2602600 | Generic | 2026/10/22 | Not stated by source | CDE |
| Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized | CYHS2602641 | Generic | 2026/10/29 | Not stated by source | CDE |
API registrations
Non-component matches: 11 companies with A status and 2 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 |
|---|---|---|---|---|---|---|
| 阿仑膦酸钠 · No verified English name | Divi's Laboratories Limited | Y20260000059 | I | Exact ingredient | 2026/07/22 | CDE |
| 阿仑膦酸钠 · No verified English name | Nanjing Jiu Xiao Pharma Co., Ltd. romanized | Y20250000219 | A | Exact ingredient | 2026/08/25 | CDE |
| 阿仑膦酸钠 · No verified English name | PHARMACEUTICAL WORKS POLPHARMA S.A. | Y20220000174 | A | Exact ingredient | 2026/08/12 | CDE |
| 阿仑膦酸钠 · No verified English name | Shaanxi Han Jiang Pharma Group Co., Ltd. romanized | Y20190009556 | A | Exact ingredient | 2025/10/12 | CDE |
| 阿仑膦酸钠 · No verified English name | Hainan Zhong He Pharma Co., Ltd. romanized | Y20190006203 | A | Exact ingredient | 2024/07/11 | CDE |
| 阿仑膦酸钠 · No verified English name | Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | Y20190004386 | A | Exact ingredient | 2024/07/05 | CDE |
| 阿仑膦酸钠 · No verified English name | Hainan Yi Er Pharma Co., Ltd. romanized | Y20190004283 | A | Exact ingredient | 2024/08/01 | CDE |
| 阿仑膦酸钠 · No verified English name | CSPC OUYI PHARMACEUTICAL CO., LTD. | Y20190003357 | A | Exact ingredient | 2024/05/29 | CDE |
| 阿仑膦酸钠 · No verified English name | Beijing Foyou Pharma CO.,LTD | Y20190003085 | A | Exact ingredient | 2025/01/18 | CDE |
| 阿仑膦酸钠 · No verified English name | Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20190002714 | A | Exact ingredient | 2025/03/27 | CDE |
| 阿仑膦酸钠 · No verified English name | Hangzhou Ao Yi Bao Ling Pharma Co., Ltd. romanized | Y20190001315 | A | Exact ingredient | — | CDE |
| 阿仑膦酸钠 · No verified English name | Shaanxi Han Jiang Pharma Group Co., Ltd. romanized | Y20180000234 | I | Exact ingredient | 2019/04/29 | CDE |
| 阿仑膦酸钠 · No verified English name | Shao Xing Min Sheng Pharmaceuticals Co., Ltd. romanized | Y20170000812 | A | Exact ingredient | 2024/08/02 | 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.
-
2026/10/29Accepted
Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized
CYHS2602641
Fact date: 2026/10/29 · Site observation date: 2026/10/30
View source ↗ -
2026/10/22Accepted
Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized
CYHS2602600
Fact date: 2026/10/22 · Site observation date: 2026/10/23
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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