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Mycophenolate Mofetil Capsules

As of 13 November 2026, for Mycophenolate Mofetil Capsules, 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 12 holders.

Companies, stages and changes, with each record available on this page.

Listed in the US FDA Orange Book as CELLCEPT (NDA 050722, ROCHE PALO ALTO LLC).

Last 90 days: Accepted: 2 applications

Current coverage may be incomplete

Follow for free
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 2 of 2 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: Capsules. 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
CELLCEPT ROCHE PALO ALTO LLC NDA 050722 · Product no. 001 CAPSULE ORAL HUMAN PRESCRIPTION DRUG 1995/05/03

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
CELLCEPT ROCHE PALO ALTO LLC NDA 050723 · Product no. 001 TABLET ORAL HUMAN PRESCRIPTION DRUG 1997/06/19
CELLCEPT ROCHE PALO ALTO LLC NDA 050759 · Product no. 001 FOR SUSPENSION ORAL HUMAN PRESCRIPTION DRUG 1998/10/01
MYHIBBIN AZURITY PHARMACEUTICALS INC NDA 216482 · Product no. 001 SUSPENSION ORAL HUMAN PRESCRIPTION DRUG 2024/05/01

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: 12 holders; 7 in the quality-and-efficacy consistency-evaluation category, and 3 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Mylan Laboratories LimitedMylan Laboratories Limited国药准字HJ202500982025/08/190.25gGeneric approved under the new chemical-drug registration classificationCDE
Wuxi Fu Qi Pharmaceutical Co., Ltd. romanizedWuxi Fu Qi Pharmaceutical Co., Ltd. romanized国药准字H200806422024/05/100.25gDrug that passed quality-and-efficacy consistency evaluationCDE
Zhejiang Jian Feng Pharma Co., Ltd. romanizedZhejiang Jian Feng Pharma Co., Ltd. romanized国药准字H200702672023/09/120.25gDrug that passed quality-and-efficacy consistency evaluationCDE
NORTH CHINA PHARMACEUTICAL COMPANY.LTDNORTH CHINA PHARMACEUTICAL COMPANY.LTD国药准字H200802972022/12/070.25gDrug that passed quality-and-efficacy consistency evaluationCDE
Shandong Xin Shi Dai Pharma Co., Ltd. romanizedShandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H202234412022/06/280.25gGeneric approved under the new chemical-drug registration classificationCDE
HUNAN WARRANT PHARMACEUTICAL CO.,LTDHUNAN WARRANT PHARMACEUTICAL CO.,LTD国药准字H200800162022/03/080.25gDrug that passed quality-and-efficacy consistency evaluationCDE
Hainan Xian Sheng Pharma Co., Ltd. romanizedHainan Xian Sheng Pharma Co., Ltd. romanized国药准字H20213150—0.25gGeneric approved under the new chemical-drug registration classificationCDE
Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanizedHangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized国药准字H200800032020/12/230.25gDrug that passed quality-and-efficacy consistency evaluationCDE
Qiong Lai Tian Yin Pharmaceutical Co., Ltd. romanizedQiong Lai Tian Yin Pharmaceutical Co., Ltd. romanized国药准字H200808192020/12/030.25gDrug that passed quality-and-efficacy consistency evaluationCDE
Han Hui Pharmaceutical Co., Ltd. romanizedZhejiang Hai Zheng Pharma Co., Ltd. romanized国药准字H200700812020/04/280.25gDrug that passed quality-and-efficacy consistency evaluationCDE
Name not romanizedShanghai Luo Shi Pharmaceutical Co., Ltd. romanized国药准字H200312402003/12/120.25gOther drugCDE
Roche Registration Ltd.Roche S.p.A.H201303631997/07/240.25gImported 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: 13 distinct approval numbers and 13 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Shanghai Luo Shi Pharmaceutical Co., Ltd. romanized国药准字H200312400.25gCategory BXL04AAM026E001010100723NHSA
Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized国药准字H200806420.25gCategory BXL04AAM026E001010101698NHSA
Qiong Lai Tian Yin Pharmaceutical Co., Ltd. romanized国药准字H200808190.25gCategory BXL04AAM026E001010102067NHSA
NORTH CHINA PHARMACEUTICAL COMPANY.LTD国药准字H200802970.25gCategory BXL04AAM026E001010102697NHSA
Shandong Hua Lu Pharmaceutical Co., Ltd. romanized国药准字H201001180.25gCategory BXL04AAM026E001010104098NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H200807640.25gCategory BXL04AAM026E001010104127NHSA
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H202234410.25gCategory BXL04AAM026E001010104188NHSA
Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized国药准字H200800030.25gCategory BXL04AAM026E001010104520NHSA
Zhejiang Zhang Dian Drug Technology Kai Fa Co., Ltd. romanized国药准字H200700810.25gCategory BXL04AAM026E001010104641NHSA
Zhejiang Jian Feng Pharma Co., Ltd. romanized国药准字H200702670.25gCategory BXL04AAM026E001010104655NHSA
HUNAN WARRANT PHARMACEUTICAL CO.,LTD国药准字H200800160.25gCategory BXL04AAM026E001010104929NHSA
Hainan Xian Sheng Pharma Co., Ltd. romanized国药准字H202131500.25gCategory BXL04AAM026E001010105849NHSA
Bei Da Pharmaceuticals Co., Ltd. romanized国药准字H20133045250mgCategory BXL04AAM026E001010109660NHSA
Shanghai Luo Shi Pharmaceutical Co., Ltd. romanized国药准字H200312400.25gCategory BXL04AAM026E001010200723NHSA
Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized国药准字H200806420.25gCategory BXL04AAM026E001010201698NHSA
CISEN PHARMACEUTICAL CO., LTD.国药准字H200807640.25gCategory BXL04AAM026E001010204127NHSA
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H202234410.25gCategory BXL04AAM026E001010204188NHSA
Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized国药准字H200800030.25gCategory BXL04AAM026E001010204520NHSA
Zhejiang Zhang Dian Drug Technology Kai Fa Co., Ltd. romanized国药准字H200700810.25gCategory BXL04AAM026E001010204641NHSA
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H202234410.25gCategory BXL04AAM026E001010304188NHSA
Zhejiang Zhang Dian Drug Technology Kai Fa Co., Ltd. romanized国药准字H200700810.25gCategory BXL04AAM026E001010304641NHSA
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H202234410.25gCategory BXL04AAM026E001010404188NHSA
Zhejiang Zhang Dian Drug Technology Kai Fa Co., Ltd. romanized国药准字H200700810.25gCategory BXL04AAM026E001010404641NHSA
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H202234410.25gCategory BXL04AAM026E001010504188NHSA
Zhejiang Zhang Dian Drug Technology Kai Fa Co., Ltd. romanized国药准字H200700810.25gCategory BXL04AAM026E001010504641NHSA
HUNAN WARRANT PHARMACEUTICAL CO.,LTD国药准字H200800160.25gCategory BXL04AAM026E001020104929NHSA
HUNAN WARRANT PHARMACEUTICAL CO.,LTD国药准字H200800160.25gCategory BXL04AAM026E001020204929NHSA

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 4 distinct first applicants.

Generic 2 · Supplement 2

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Zhejiang Nord Pharmaceutical Co., LtdCYHS2600006Generic2026/01/05Not stated by sourceCDE
Shanghai Luo Shi Pharmaceutical Co., Ltd. romanizedCYHB2601769Supplement2026/09/20Not stated by sourceCDE
Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanizedCYHS2601858Generic2026/08/03Not stated by sourceCDE
Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanizedCYHB2602033Supplement2026/11/09Not 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
Zhejiang Nord Pharmaceutical Co., LtdCYHS2600006Generic2026/01/05Not stated by sourceCDE
Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanizedCYHS2601858Generic2026/08/03Not stated by sourceCDE
API registrations

Non-component matches: 28 companies with A status and 1 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
吗替麦考酚酯 · No verified English nameBiocon LimitedY20240001442IExact ingredient2025/05/16CDE
吗替麦考酚酯 · No verified English nameConcord Biotech LimitedY20210000932AExact ingredient2024/11/09CDE
吗替麦考酚酯 · No verified English nameRoche Pharma (Schweiz) AGY20190000656AExact ingredient2026/06/16CDE
吗替麦考酚酯 · No verified English nameRoche Pharma (Schweiz) Ltd.Y20190009938AExact ingredient—CDE
吗替麦考酚酯 · No verified English nameRoche Pharma (Schweiz) Ltd.Y20190009937AExact ingredient—CDE
吗替麦考酚酯 · No verified English nameHai Zheng Pharma (Hangzhou) Co., Ltd. romanizedY20190009807AExact ingredient—CDE
吗替麦考酚酯 · No verified English nameGuo Yao Group Chuan Kang Pharmaceutical Co., Ltd. romanizedY20190009643AExact ingredient2025/09/27CDE
吗替麦考酚酯 · No verified English nameWuxi Fu Qi Pharmaceutical Co., Ltd. romanizedY20190008682AExact ingredient2026/07/10CDE
吗替麦考酚酯 · No verified English nameFujian Ke Rui Pharma Co., Ltd. romanizedY20190008499AExact ingredient2024/09/04CDE
吗替麦考酚酯 · No verified English nameYi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanizedY20190007112AExact ingredient2023/03/24CDE
吗替麦考酚酯 · No verified English nameLi Zhu Group Xin Bei Jiang Pharmaceutical Co., Ltd. romanizedY20190006954AExact ingredient2023/03/24CDE
吗替麦考酚酯 · No verified English nameNanjing Jing Lun Pharmaceutical Co., Ltd. romanizedY20190006521AExact ingredient—CDE
吗替麦考酚酯 · No verified English nameHainan Zhuo Ke Pharmaceutical Co., Ltd. romanizedY20190006157AExact ingredient2026/02/25CDE
吗替麦考酚酯 · No verified English nameHubei Wu Shi Pharma Co., Ltd. romanizedY20190006087AExact ingredient2025/12/24CDE
吗替麦考酚酯 · No verified English nameJi Chuan Pharma Group Co., Ltd. romanizedY20190006082AExact ingredient—CDE
吗替麦考酚酯 · No verified English nameShandong Chen Long Pharma Co., Ltd. romanizedY20190005848AExact ingredient2024/02/08CDE
吗替麦考酚酯 · No verified English nameChongqing Lai Mei Long Yu Pharma Co., Ltd. romanizedY20190005179AExact ingredient2025/06/05CDE
吗替麦考酚酯 · No verified English nameFuzhou Hai Wang Fu Yao Pharmaceutical Co., Ltd. romanizedY20190005113AExact ingredient—CDE
吗替麦考酚酯 · No verified English nameHebei Bai Qi Pharma Co., Ltd. romanizedY20190004938AExact ingredient—CDE
吗替麦考酚酯 · No verified English nameJiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanizedY20190004770AExact ingredient2025/06/28CDE
吗替麦考酚酯 · No verified English nameHua Bei Pharmaceutical Hua Sheng Co., Ltd. romanizedY20190004299AExact ingredient2024/12/31CDE
吗替麦考酚酯 · No verified English nameYang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanizedY20190004067AExact ingredient—CDE
吗替麦考酚酯 · No verified English nameHubei Tian Yi Pharma Co., Ltd. romanizedY20190004056AExact ingredient2026/05/20CDE
吗替麦考酚酯 · No verified English nameHunan Hua Na Da Pharmaceutical Factory Shou Xing Drug Co., Ltd. romanizedY20190004030AExact ingredient2025/12/19CDE
吗替麦考酚酯 · No verified English nameJiangsu Shen Long Pharma Co., Ltd. romanizedY20190003083AExact ingredient—CDE
吗替麦考酚酯 · No verified English nameShandong Xin Shi Dai Pharma Co., Ltd. romanizedY20190002063AExact ingredient2025/01/11CDE
吗替麦考酚酯 · No verified English nameJiangsu Jiu Yang Biopharmaceutical Co., Ltd. romanizedY20190001419AExact ingredient2026/10/29CDE
吗替麦考酚酯 · No verified English nameChongqing Xin Da Xin Pharma Co., Ltd. romanizedY20190001329AExact ingredient2026/05/20CDE
吗替麦考酚酯 · No verified English nameHua Run San Jiu (Tang Shan) Pharma Co., Ltd. romanizedY20190001226AExact ingredient2024/04/11CDE
吗替麦考酚酯 · No verified English nameHai Zheng Pharma (Hangzhou) Co., Ltd. romanizedY20180000985AExact ingredient2024/12/07CDE
吗替麦考酚酯 · No verified English nameRoche Pharma (Schweiz) Ltd.Y20170002082AExact ingredient—CDE
吗替麦考酚酯 · No verified English nameShanghai Luo Shi Pharmaceutical Co., Ltd. romanizedY20170001961AExact ingredient2019/01/14CDE
吗替麦考酚酯 · No verified English nameGuo Yao Group Chuan Kang Pharmaceutical Co., Ltd. romanizedY20170001960AExact ingredient2022/11/08CDE

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. 2026/11/09Accepted

    Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized

    CYHB2602033

    Fact date: 2026/11/09 · Site observation date: 2026/11/10

    View source ↗
  2. 2026/09/20Accepted

    Shanghai Luo Shi Pharmaceutical Co., Ltd. romanized

    CYHB2601769

    Fact date: 2026/09/20 · 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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