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Sevelamer Carbonate Tablets(碳酸司维拉姆片)
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 holders15View records ↓
Under-review filings4View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers15View records ↓
API companies with A status7View records ↓
Chemical-drug catalogue
Loaded records: 15 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 14 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 |
|---|---|---|---|---|---|---|
| Apothecon Pharmaceuticals Pvt. Ltd. | Apothecon Pharmaceuticals Pvt. Ltd. | 国药准字HJ20260027 | 2026/03/17 | 0.8g | 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 |
| 浙江昂利康制药股份有限公司 | 浙江昂利康制药股份有限公司 | 国药准字H20263512 | 2026/03/03 | 0.8g | 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 |
| 南京泽恒医药技术开发有限公司 | 江苏欧歌制药有限公司 | 国药准字H20255916 | 2025/11/12 | 0.8g | 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 |
| 平光制药股份有限公司 | 平光制药股份有限公司 | 国药准字H20255914 | 2025/11/12 | 0.8g | 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 |
| 湘北威尔曼制药股份有限公司 | 湘北威尔曼制药股份有限公司 | 国药准字H20255915 | 2025/11/12 | 0.8g | 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 |
| 国药集团致君（深圳）坪山制药有限公司 | 国药集团致君（深圳）坪山制药有限公司 | 国药准字H20249635 | 2024/12/01 | 0.8g | 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 |
| 中美华世通生物医药科技（武汉）股份有限公司 | 湖北华世通生物医药科技有限公司 | 国药准字H20234529 | 2023/11/21 | 0.8g | 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 |
| Aurobindo Pharma Limited | Aurobindo Pharma Limited | 国药准字HJ20230122 | 2023/10/27 | 0.8g | 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 |
| 上海安羡医药科技有限公司 | 江苏宣泰药业有限公司 | 国药准字H20234169 | 2023/09/19 | 0.8g | 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 |
| Amneal Pharmaceuticals Private Limited | Amneal Pharmaceuticals Private Limited | 国药准字HJ20230102 | 2023/08/15 | 0.8g | 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 |
| Dr. Reddy`s Laboratories Limited | Dr. Reddy`s Laboratories Limited | 国药准字HJ20230042 | 2023/04/28 | 0.8g | 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 |
| 海南先声药业有限公司 | 海南先声药业有限公司 | 国药准字H20233347 | 2023/03/24 | 0.8g | 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 |
| 山东新华制药股份有限公司 | 山东新华制药股份有限公司 | 国药准字H20233203 | 2023/02/21 | 0.8g | 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 |
| 南京恒生制药有限公司 | 南京恒生制药有限公司 | 国药准字H20203303 | 2020/07/08 | 0.8g | 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 |
| Genzyme Europe B.V. | Genzyme Ireland Limited | H20181037;H20181038;H20181039 | 2013/06/03 | 800mg | 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: 15 distinct approval numbers and 15 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| 国药集团致君(深圳)坪山制药有限公司 | 国药准字H20249635 | 0.8g | Category B (乙) | XV03AES240A001010100430 | NHSA |
| 南京恒生制药有限公司 | 国药准字H20203303 | 0.8g | Category B (乙) | XV03AES240A001010101565 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H20233203 | 0.8g | Category B (乙) | XV03AES240A001010104187 | NHSA |
| 湘北威尔曼制药股份有限公司 | 国药准字H20255915 | 0.8g | Category B (乙) | XV03AES240A001010105025 | NHSA |
| 海南先声药业有限公司 | 国药准字H20233347 | 0.8g | Category B (乙) | XV03AES240A001010105849 | NHSA |
| Aurobindo Pharma Limited | 国药准字HJ20230122 | 0.8g | Category B (乙) | XV03AES240A001010178242 | NHSA |
| Dr. Reddy`s Laboratories Limited | 国药准字HJ20230042 | 0.8g | Category B (乙) | XV03AES240A001010178377 | NHSA |
| Genzyme Europe B.V. | 国药准字J20130160 | 800mg | Category B (乙) | XV03AES240A001010178450 | NHSA |
| 平光制药股份有限公司 | 国药准字H20255914 | 0.8g | Category B (乙) | XV03AES240A001010180610 | NHSA |
| 上海宣泰医药科技股份有限公司 | 国药准字H20234169 | 0.8g | Category B (乙) | XV03AES240A001010181522 | NHSA |
| 南京泽恒医药技术开发有限公司 | 国药准字H20255916 | 0.8g | Category B (乙) | XV03AES240A001010183339 | NHSA |
| 中美华世通生物医药科技(武汉)股份有限公司 | 国药准字H20234529 | 0.8g | Category B (乙) | XV03AES240A001010184561 | NHSA |
| Amneal Pharmaceuticals Private Limited | 国药准字HJ20230102 | 0.8g | Category B (乙) | XV03AES240A001010184832 | NHSA |
| Apothecon Pharmaceuticals Pvt. Ltd. | 国药准字HJ20260027 | 0.8g | Category B (乙) | XV03AES240A001010185347 | NHSA |
| 山东新华制药股份有限公司 | 国药准字H20233203 | 0.8g | Category B (乙) | XV03AES240A001010204187 | NHSA |
| 湘北威尔曼制药股份有限公司 | 国药准字H20255915 | 0.8g | Category B (乙) | XV03AES240A001010205025 | NHSA |
| Dr. Reddy`s Laboratories Limited | 国药准字HJ20230042 | 0.8g | Category B (乙) | XV03AES240A001010278377 | NHSA |
| Genzyme Europe B.V. | 国药准字J20130160 | 800mg | Category B (乙) | XV03AES240A001010278450 | NHSA |
| 上海宣泰医药科技股份有限公司 | 国药准字H20234169 | 0.8g | Category B (乙) | XV03AES240A001010281522 | NHSA |
| 中美华世通生物医药科技(武汉)股份有限公司 | 国药准字H20234529 | 0.8g | Category B (乙) | XV03AES240A001010284561 | NHSA |
| Amneal Pharmaceuticals Private Limited | 国药准字HJ20230102 | 0.8g | Category B (乙) | XV03AES240A001010284832 | NHSA |
| 湘北威尔曼制药股份有限公司 | 国药准字H20255915 | 0.8g | Category B (乙) | XV03AES240A001010305025 | NHSA |
| Sanofi B.V. | 国药准字HJ20181037 | 800mg | Category B (乙) | XV03AES240A001010378450 | NHSA |
| 中美华世通生物医药科技(武汉)股份有限公司 | 国药准字H20234529 | 0.8g | Category B (乙) | XV03AES240A001010384561 | NHSA |
| 湘北威尔曼制药股份有限公司 | 国药准字H20255915 | 0.8g | Category B (乙) | XV03AES240A001010405025 | NHSA |
| Sanofi B.V. | 国药准字HJ20181037 | 800mg | Category B (乙) | XV03AES240A001010478450 | NHSA |
| 湘北威尔曼制药股份有限公司 | 国药准字H20255915 | 0.8g | Category B (乙) | XV03AES240A001010505025 | NHSA |
| 湘北威尔曼制药股份有限公司 | 国药准字H20255915 | 0.8g | Category B (乙) | XV03AES240A001010605025 | NHSA |
| 湘北威尔曼制药股份有限公司 | 国药准字H20255915 | 0.8g | Category B (乙) | XV03AES240A001010705025 | NHSA |
| 湘北威尔曼制药股份有限公司 | 国药准字H20255915 | 0.8g | Category B (乙) | XV03AES240A001010805025 | NHSA |
| 湘北威尔曼制药股份有限公司 | 国药准字H20255915 | 0.8g | Category B (乙) | XV03AES240A001010905025 | NHSA |
| 湘北威尔曼制药股份有限公司 | 国药准字H20255915 | 0.8g | Category B (乙) | XV03AES240A001011005025 | NHSA |
| 湘北威尔曼制药股份有限公司 | 国药准字H20255915 | 0.8g | Category B (乙) | XV03AES240A001011105025 | NHSA |
| 湘北威尔曼制药股份有限公司 | 国药准字H20255915 | 0.8g | Category B (乙) | XV03AES240A001011205025 | NHSA |
| 湘北威尔曼制药股份有限公司 | 国药准字H20255915 | 0.8g | Category B (乙) | XV03AES240A001011305025 | NHSA |
| 湘北威尔曼制药股份有限公司 | 国药准字H20255915 | 0.8g | Category B (乙) | XV03AES240A001011405025 | NHSA |
| 湘北威尔曼制药股份有限公司 | 国药准字H20255915 | 0.8g | Category B (乙) | XV03AES240A001011505025 | NHSA |
| Apothecon Pharmaceuticals Pvt. Ltd. | 国药准字HJ20260027 | 0.8g | Category B (乙) | XV03AES240A001010285347 | 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 2 · Import re-registration 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| 江苏天士力帝益药业有限公司 | CYHS2601599 | Generic | 2026/07/06 | Not stated by source | CDE |
| Sanofi Winthrop Industrie;Sanofi (China) Investment Co. Ltd. | JYHZ2600199 | Import re-registration | 2026/08/19 | Not stated by source | CDE |
| Sanofi Winthrop Industrie;Sanofi (China) Investment Co. Ltd. | JYHZ2600198 | Import re-registration | 2026/08/19 | Not stated by source | CDE |
| 海南赛立克药业有限公司 | CYHS2600686 | Generic | 2026/03/19 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
API registrations
Non-component matches: 7 companies with A status and 7 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 |
|---|---|---|---|---|---|---|
| 碳酸司维拉姆 | 雅本化学股份有限公司 | Y20230000946 | I | Exact ingredient | 2023/12/28 | CDE |
| 碳酸司维拉姆 | 苏州盛达药业有限公司 | Y20230001130 | I | Exact ingredient | 2023/12/05 | CDE |
| 碳酸司维拉姆 | 江苏恒盛药业有限公司 | Y20230000774 | I | Exact ingredient | 2023/09/05 | CDE |
| 碳酸司维拉姆 | AMI LIFESCIENCES PVT.LTD. | Y20230000128 | I | Exact ingredient | 2023/08/29 | CDE |
| 碳酸司维拉姆 | 台耀化学股份有限公司 | Y20220001209 | I | Exact ingredient | 2023/03/30 | CDE |
| 碳酸司维拉姆 | Apothecon Pharmaceuticals Pvt.Ltd. | Y20220001050 | A | Exact ingredient | 2025/03/06 | CDE |
| 碳酸司维拉姆 | Solara Active Pharma Sciences Limited | Y20220000327 | A | Exact ingredient | 2025/11/22 | CDE |
| 碳酸司维拉姆 | 湖北华世通生物医药科技有限公司 | Y20220000545 | A | Exact ingredient | 2025/07/22 | CDE |
| 碳酸司维拉姆 | 山东新华制药股份有限公司 | Y20210000306 | A | Exact ingredient | 2024/06/08 | CDE |
| 碳酸司维拉姆 | Apitoria Pharma Private Limited | Y20190000430 | A | Exact ingredient | 2025/05/06 | CDE |
| 碳酸司维拉姆 | Emcure Pharmaceuticals Limited | Y20190000649 | I | Exact ingredient | 2019/11/20 | CDE |
| 碳酸司维拉姆 | 南京恒生制药有限公司 | Y20190000205 | A | Exact ingredient | 2025/03/28 | CDE |
| 碳酸司维拉姆 | Formosa Laboratories, Inc. | Y20180001514 | A | Exact ingredient | 2026/06/10 | CDE |
| 碳酸司维拉姆 | Mylan Laboratories Limited（Unit-9） | Y20180001561 | I | Exact ingredient | 2019/01/02 | 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: 2026/11/10 07:23. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
-
2026/08/19Accepted
Sanofi Winthrop Industrie;Sanofi (China) Investment Co. Ltd.
JYHZ2600199
Fact date: 2026/08/19 · Site observation date: 2026/10/22
View source ↗ -
2026/08/19Accepted
Sanofi Winthrop Industrie;Sanofi (China) Investment Co. Ltd.
JYHZ2600198
Fact date: 2026/08/19 · 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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