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Sevelamer Carbonate Tablets

As 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

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Complete CDE snapshot
2026/11/13 06:42
Matching scope
Same generic name; dosage forms and combinations kept separate

US Orange Book listing

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.

Same dosage form

Brand nameApplicant (source text)Application numberDosage 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

Other dosage forms of the same ingredient

Brand nameApplicant (source text)Application numberDosage 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.

Ingredient cross-list details ↗

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.

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 holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Apothecon Pharmaceuticals Pvt. Ltd.Apothecon Pharmaceuticals Pvt. Ltd.国药准字HJ202600272026/03/170.8gGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang AngLiKang Pharmaceutical CO.,LTD.Zhejiang AngLiKang Pharmaceutical CO.,LTD.国药准字H202635122026/03/030.8gGeneric approved under the new chemical-drug registration classificationCDE
Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanizedJiangsu Ou Ge Pharmaceutical Co., Ltd. romanized国药准字H202559162025/11/120.8gGeneric approved under the new chemical-drug registration classificationCDE
Ping Guang Pharmaceutical Co., Ltd. romanizedPing Guang Pharmaceutical Co., Ltd. romanized国药准字H202559142025/11/120.8gGeneric approved under the new chemical-drug registration classificationCDE
Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanizedXiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized国药准字H202559152025/11/120.8gGeneric approved under the new chemical-drug registration classificationCDE
Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanizedGuo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized国药准字H202496352024/12/010.8gGeneric approved under the new chemical-drug registration classificationCDE
Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanizedHubei Hua Shi Tong Biopharmaceuticals Technology Co., Ltd. romanized国药准字H202345292023/11/210.8gGeneric approved under the new chemical-drug registration classificationCDE
Aurobindo Pharma LimitedAurobindo Pharma Limited国药准字HJ202301222023/10/270.8gGeneric approved under the new chemical-drug registration classificationCDE
Shanghai An Xian Pharmaceuticals Technology Co., Ltd. romanizedJiangsu Xuan Tai Pharma Co., Ltd. romanized国药准字H202341692023/09/190.8gGeneric approved under the new chemical-drug registration classificationCDE
Amneal Pharmaceuticals Private LimitedAmneal Pharmaceuticals Private Limited国药准字HJ202301022023/08/150.8gGeneric approved under the new chemical-drug registration classificationCDE
Name not romanizedName not romanized国药准字HJ202300422023/04/280.8gGeneric approved under the new chemical-drug registration classificationCDE
Hainan Xian Sheng Pharma Co., Ltd. romanizedHainan Xian Sheng Pharma Co., Ltd. romanized国药准字H202333472023/03/240.8gGeneric approved under the new chemical-drug registration classificationCDE
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITEDSHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H202332032023/02/210.8gGeneric approved under the new chemical-drug registration classificationCDE
Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanizedNanjing Heng Sheng Pharmaceutical Co., Ltd. romanized国药准字H202033032020/07/080.8gGeneric approved under the new chemical-drug registration classificationCDE
Genzyme Europe B.V.Genzyme Ireland LimitedH20181037;H20181038;H201810392013/06/03800mgImported originator drugCDE

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 / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized国药准字H202496350.8gCategory BXV03AES240A001010100430NHSA
Nanjing Heng Sheng Pharmaceutical Co., Ltd. romanized国药准字H202033030.8gCategory BXV03AES240A001010101565NHSA
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H202332030.8gCategory BXV03AES240A001010104187NHSA
Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized国药准字H202559150.8gCategory BXV03AES240A001010105025NHSA
Hainan Xian Sheng Pharma Co., Ltd. romanized国药准字H202333470.8gCategory BXV03AES240A001010105849NHSA
Aurobindo Pharma Limited国药准字HJ202301220.8gCategory BXV03AES240A001010178242NHSA
Name not romanized国药准字HJ202300420.8gCategory BXV03AES240A001010178377NHSA
Genzyme Europe B.V.国药准字J20130160800mgCategory BXV03AES240A001010178450NHSA
Ping Guang Pharmaceutical Co., Ltd. romanized国药准字H202559140.8gCategory BXV03AES240A001010180610NHSA
Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized国药准字H202341690.8gCategory BXV03AES240A001010181522NHSA
Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized国药准字H202559160.8gCategory BXV03AES240A001010183339NHSA
Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized国药准字H202345290.8gCategory BXV03AES240A001010184561NHSA
Amneal Pharmaceuticals Private Limited国药准字HJ202301020.8gCategory BXV03AES240A001010184832NHSA
Apothecon Pharmaceuticals Pvt. Ltd.国药准字HJ202600270.8gCategory BXV03AES240A001010185347NHSA
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H202332030.8gCategory BXV03AES240A001010204187NHSA
Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized国药准字H202559150.8gCategory BXV03AES240A001010205025NHSA
Name not romanized国药准字HJ202300420.8gCategory BXV03AES240A001010278377NHSA
Genzyme Europe B.V.国药准字J20130160800mgCategory BXV03AES240A001010278450NHSA
Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized国药准字H202341690.8gCategory BXV03AES240A001010281522NHSA
Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized国药准字H202345290.8gCategory BXV03AES240A001010284561NHSA
Amneal Pharmaceuticals Private Limited国药准字HJ202301020.8gCategory BXV03AES240A001010284832NHSA
Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized国药准字H202559150.8gCategory BXV03AES240A001010305025NHSA
Sanofi B.V.国药准字HJ20181037800mgCategory BXV03AES240A001010378450NHSA
Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized国药准字H202345290.8gCategory BXV03AES240A001010384561NHSA
Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized国药准字H202559150.8gCategory BXV03AES240A001010405025NHSA
Sanofi B.V.国药准字HJ20181037800mgCategory BXV03AES240A001010478450NHSA
Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized国药准字H202559150.8gCategory BXV03AES240A001010505025NHSA
Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized国药准字H202559150.8gCategory BXV03AES240A001010605025NHSA
Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized国药准字H202559150.8gCategory BXV03AES240A001010705025NHSA
Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized国药准字H202559150.8gCategory BXV03AES240A001010805025NHSA
Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized国药准字H202559150.8gCategory BXV03AES240A001010905025NHSA
Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized国药准字H202559150.8gCategory BXV03AES240A001011005025NHSA
Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized国药准字H202559150.8gCategory BXV03AES240A001011105025NHSA
Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized国药准字H202559150.8gCategory BXV03AES240A001011205025NHSA
Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized国药准字H202559150.8gCategory BXV03AES240A001011305025NHSA
Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized国药准字H202559150.8gCategory BXV03AES240A001011405025NHSA
Xiang Bei Wei Er Man Pharmaceutical Co., Ltd. romanized国药准字H202559150.8gCategory BXV03AES240A001011505025NHSA
Apothecon Pharmaceuticals Pvt. Ltd.国药准字HJ202600270.8gCategory BXV03AES240A001010285347NHSA

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

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanizedCYHS2601599Generic2026/07/06Not stated by sourceCDE
Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.JYHZ2600199Import re-registration2026/08/19Not stated by sourceCDE
Sanofi Winthrop Industrie; Sanofi (China) Investment Co. Ltd.JYHZ2600198Import re-registration2026/08/19Not stated by sourceCDE
Hainan Sai Li Ke Pharma Co., Ltd. romanizedCYHS2600686Generic2026/03/19Not stated by sourceCDE
New generic filings in 2026

Loaded records: 2 filings and 2 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanizedCYHS2601599Generic2026/07/06Not stated by sourceCDE
Hainan Sai Li Ke Pharma Co., Ltd. romanizedCYHS2600686Generic2026/03/19Not stated by sourceCDE
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.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
碳酸司维拉姆 · No verified English nameYa Ben Chemical Co., Ltd. romanizedY20230000946IExact ingredient2023/12/28CDE
碳酸司维拉姆 · No verified English nameSuzhou Sheng Da Pharma Co., Ltd. romanizedY20230001130IExact ingredient2023/12/05CDE
碳酸司维拉姆 · No verified English nameJiangsu Heng Sheng Pharma Co., Ltd. romanizedY20230000774IExact ingredient2023/09/05CDE
碳酸司维拉姆 · No verified English nameAMI LIFESCIENCES PVT.LTD.Y20230000128IExact ingredient2023/08/29CDE
碳酸司维拉姆 · No verified English nameTai Yao Chemical Co., Ltd. romanizedY20220001209IExact ingredient2023/03/30CDE
碳酸司维拉姆 · No verified English nameApothecon Pharmaceuticals Pvt.Ltd.Y20220001050AExact ingredient2025/03/06CDE
碳酸司维拉姆 · No verified English nameSolara Active Pharma Sciences LimitedY20220000327AExact ingredient2025/11/22CDE
碳酸司维拉姆 · No verified English nameHubei Hua Shi Tong Biopharmaceuticals Technology Co., Ltd. romanizedY20220000545AExact ingredient2025/07/22CDE
碳酸司维拉姆 · No verified English nameSHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITEDY20210000306AExact ingredient2024/06/08CDE
碳酸司维拉姆 · No verified English nameApitoria Pharma Private LimitedY20190000430AExact ingredient2025/05/06CDE
碳酸司维拉姆 · No verified English nameEmcure Pharmaceuticals LimitedY20190000649IExact ingredient2019/11/20CDE
碳酸司维拉姆 · No verified English nameNanjing Heng Sheng Pharmaceutical Co., Ltd. romanizedY20190000205AExact ingredient2025/03/28CDE
碳酸司维拉姆 · No verified English nameFormosa Laboratories, Inc.Y20180001514AExact ingredient2026/06/10CDE
碳酸司维拉姆 · No verified English nameMylan Laboratories Limited(Unit-9)Y20180001561IExact ingredient2019/01/02CDE

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.

  1. 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 ↗
  2. 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: 2026/11/13 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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