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Sign in to subscribeAs of 13 November 2026, for Sevelamer Carbonate Tablets, 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 15 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 2 applications
Current coverage may be incomplete
The brand names come from the US FDA Orange Book and describe US listing records for this active ingredient. They do not indicate that products under these brand names are approved or sold in China, or that Chinese applicants are affiliated with US holders.
Orange Book source export date: 2026/11/06. Version: 2026-11-06.
Showing 1 of 1 distinct brand names.
A brand with different source forms or statuses can appear on multiple rows and in both groups. Distinct brand names are counted once globally, with a limit of five.
Verified official English dosage form: Tablets. Listings are grouped by the source dosage form and route; records without a clear correspondence are listed in the other group. Grouping does not establish product equivalence.
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| RENVELA | SANOFI GENZYME | NDA 022127 · Product no. 001 | TABLET | ORAL | DISCONTINUED | 2007/10/19 |
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| RENVELA | GENZYME CORP | NDA 022318 · Product no. 002 | FOR SUSPENSION | ORAL | DISCONTINUED | 2009/02/18 |
| RENVELA | GENZYME CORP | NDA 022318 · Product no. 001 | FOR SUSPENSION | ORAL | DISCONTINUED | 2009/08/12 |
Same-form/route listings come first, followed by other forms/routes. Within each group, source prescription/OTC listings precede discontinued listings; unknown statuses are last. Each status bucket is ordered by earliest approval date, ascending: pre-1982 records first, missing dates last; ties by brand name, application number and product number. The first five distinct brands in this order are selected globally. All retained source facts for those brands are shown in their own groups; a brand spanning both groups counts once.
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.
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 | CDE |
| Zhejiang AngLiKang Pharmaceutical CO.,LTD. | Zhejiang AngLiKang Pharmaceutical CO.,LTD. | 国药准字H20263512 | 2026/03/03 | 0.8g | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized | 国药准字H20255916 | 2025/11/12 | 0.8g | Generic approved under the new chemical-drug registration classification | CDE |
| Ping Guang Pharmaceutical Co., Ltd. romanized | Ping Guang Pharmaceutical Co., Ltd. romanized | 国药准字H20255914 | 2025/11/12 | 0.8g | Generic approved under the new chemical-drug registration classification | CDE |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H20255915 | 2025/11/12 | 0.8g | Generic approved under the new chemical-drug registration classification | CDE |
| Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized | Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized | 国药准字H20249635 | 2024/12/01 | 0.8g | Generic approved under the new chemical-drug registration classification | CDE |
| Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized | Hubei Hua Shi Tong Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20234529 | 2023/11/21 | 0.8g | Generic approved under the new chemical-drug registration classification | 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 | CDE |
| Shanghai An Xian Pharmaceuticals Technology Co., Ltd. romanized | Jiangsu Xuan Tai Pharma Co., Ltd. romanized | 国药准字H20234169 | 2023/09/19 | 0.8g | Generic approved under the new chemical-drug registration classification | 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 | CDE |
| Name not romanized | Name not romanized | 国药准字HJ20230042 | 2023/04/28 | 0.8g | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Xian Sheng Pharma Co., Ltd. romanized | Hainan Xian Sheng Pharma Co., Ltd. romanized | 国药准字H20233347 | 2023/03/24 | 0.8g | Generic approved under the new chemical-drug registration classification | CDE |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20233203 | 2023/02/21 | 0.8g | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized | Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20203303 | 2020/07/08 | 0.8g | Generic approved under the new chemical-drug registration classification | CDE |
| Genzyme Europe B.V. | Genzyme Ireland Limited | H20181037;H20181038;H20181039 | 2013/06/03 | 800mg | 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.
Loaded records: 15 distinct approval numbers and 15 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized | 国药准字H20249635 | 0.8g | Category B | XV03AES240A001010100430 | NHSA |
| Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20203303 | 0.8g | Category B | XV03AES240A001010101565 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20233203 | 0.8g | Category B | XV03AES240A001010104187 | NHSA |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H20255915 | 0.8g | Category B | XV03AES240A001010105025 | NHSA |
| Hainan Xian Sheng Pharma Co., Ltd. romanized | 国药准字H20233347 | 0.8g | Category B | XV03AES240A001010105849 | NHSA |
| Aurobindo Pharma Limited | 国药准字HJ20230122 | 0.8g | Category B | XV03AES240A001010178242 | NHSA |
| Name not romanized | 国药准字HJ20230042 | 0.8g | Category B | XV03AES240A001010178377 | NHSA |
| Genzyme Europe B.V. | 国药准字J20130160 | 800mg | Category B | XV03AES240A001010178450 | NHSA |
| Ping Guang Pharmaceutical Co., Ltd. romanized | 国药准字H20255914 | 0.8g | Category B | XV03AES240A001010180610 | NHSA |
| Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20234169 | 0.8g | Category B | XV03AES240A001010181522 | NHSA |
| Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | 国药准字H20255916 | 0.8g | Category B | XV03AES240A001010183339 | NHSA |
| Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized | 国药准字H20234529 | 0.8g | Category B | XV03AES240A001010184561 | NHSA |
| Amneal Pharmaceuticals Private Limited | 国药准字HJ20230102 | 0.8g | Category B | XV03AES240A001010184832 | NHSA |
| Apothecon Pharmaceuticals Pvt. Ltd. | 国药准字HJ20260027 | 0.8g | Category B | XV03AES240A001010185347 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20233203 | 0.8g | Category B | XV03AES240A001010204187 | NHSA |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H20255915 | 0.8g | Category B | XV03AES240A001010205025 | NHSA |
| Name not romanized | 国药准字HJ20230042 | 0.8g | Category B | XV03AES240A001010278377 | NHSA |
| Genzyme Europe B.V. | 国药准字J20130160 | 800mg | Category B | XV03AES240A001010278450 | NHSA |
| Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20234169 | 0.8g | Category B | XV03AES240A001010281522 | NHSA |
| Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized | 国药准字H20234529 | 0.8g | Category B | XV03AES240A001010284561 | NHSA |
| Amneal Pharmaceuticals Private Limited | 国药准字HJ20230102 | 0.8g | Category B | XV03AES240A001010284832 | NHSA |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H20255915 | 0.8g | Category B | XV03AES240A001010305025 | NHSA |
| Sanofi B.V. | 国药准字HJ20181037 | 800mg | Category B | XV03AES240A001010378450 | NHSA |
| Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized | 国药准字H20234529 | 0.8g | Category B | XV03AES240A001010384561 | NHSA |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H20255915 | 0.8g | Category B | XV03AES240A001010405025 | NHSA |
| Sanofi B.V. | 国药准字HJ20181037 | 800mg | Category B | XV03AES240A001010478450 | NHSA |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H20255915 | 0.8g | Category B | XV03AES240A001010505025 | NHSA |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H20255915 | 0.8g | Category B | XV03AES240A001010605025 | NHSA |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H20255915 | 0.8g | Category B | XV03AES240A001010705025 | NHSA |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H20255915 | 0.8g | Category B | XV03AES240A001010805025 | NHSA |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H20255915 | 0.8g | Category B | XV03AES240A001010905025 | NHSA |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H20255915 | 0.8g | Category B | XV03AES240A001011005025 | NHSA |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H20255915 | 0.8g | Category B | XV03AES240A001011105025 | NHSA |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H20255915 | 0.8g | Category B | XV03AES240A001011205025 | NHSA |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H20255915 | 0.8g | Category B | XV03AES240A001011305025 | NHSA |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H20255915 | 0.8g | Category B | XV03AES240A001011405025 | NHSA |
| Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized | 国药准字H20255915 | 0.8g | Category B | XV03AES240A001011505025 | NHSA |
| Apothecon Pharmaceuticals Pvt. Ltd. | 国药准字HJ20260027 | 0.8g | Category B | 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.
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 |
|---|---|---|---|---|---|
| Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized | 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 |
| Hainan Sai Li Ke Pharma Co., Ltd. romanized | CYHS2600686 | Generic | 2026/03/19 | Not stated by source | CDE |
Loaded records: 2 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized | CYHS2601599 | Generic | 2026/07/06 | Not stated by source | CDE |
| Hainan Sai Li Ke Pharma Co., Ltd. romanized | CYHS2600686 | Generic | 2026/03/19 | Not stated by source | CDE |
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 · No verified English name | Ya Ben Chemical Co., Ltd. romanized | Y20230000946 | I | Exact ingredient | 2023/12/28 | CDE |
| 碳酸司维拉姆 · No verified English name | Suzhou Sheng Da Pharma Co., Ltd. romanized | Y20230001130 | I | Exact ingredient | 2023/12/05 | CDE |
| 碳酸司维拉姆 · No verified English name | Jiangsu Heng Sheng Pharma Co., Ltd. romanized | Y20230000774 | I | Exact ingredient | 2023/09/05 | CDE |
| 碳酸司维拉姆 · No verified English name | AMI LIFESCIENCES PVT.LTD. | Y20230000128 | I | Exact ingredient | 2023/08/29 | CDE |
| 碳酸司维拉姆 · No verified English name | Tai Yao Chemical Co., Ltd. romanized | Y20220001209 | I | Exact ingredient | 2023/03/30 | CDE |
| 碳酸司维拉姆 · No verified English name | Apothecon Pharmaceuticals Pvt.Ltd. | Y20220001050 | A | Exact ingredient | 2025/03/06 | CDE |
| 碳酸司维拉姆 · No verified English name | Solara Active Pharma Sciences Limited | Y20220000327 | A | Exact ingredient | 2025/11/22 | CDE |
| 碳酸司维拉姆 · No verified English name | Hubei Hua Shi Tong Biopharmaceuticals Technology Co., Ltd. romanized | Y20220000545 | A | Exact ingredient | 2025/07/22 | CDE |
| 碳酸司维拉姆 · No verified English name | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Y20210000306 | A | Exact ingredient | 2024/06/08 | CDE |
| 碳酸司维拉姆 · No verified English name | Apitoria Pharma Private Limited | Y20190000430 | A | Exact ingredient | 2025/05/06 | CDE |
| 碳酸司维拉姆 · No verified English name | Emcure Pharmaceuticals Limited | Y20190000649 | I | Exact ingredient | 2019/11/20 | CDE |
| 碳酸司维拉姆 · No verified English name | Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized | Y20190000205 | A | Exact ingredient | 2025/03/28 | CDE |
| 碳酸司维拉姆 · No verified English name | Formosa Laboratories, Inc. | Y20180001514 | A | Exact ingredient | 2026/06/10 | CDE |
| 碳酸司维拉姆 · No verified English name | 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.
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.
JYHZ2600199
Fact date: 2026/08/19 · Site observation date: 2026/10/22
View source ↗JYHZ2600198
Fact date: 2026/08/19 · Site observation date: 2026/10/22
View source ↗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.
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.
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.
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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