Monthly
US$200
Billed every month
Sign in to subscribeAs 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
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.
| Brand name | Applicant (source text) | Application number | Dosage 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 |
| Brand name | Applicant (source text) | Application number | Dosage 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.
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: 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 holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Mylan Laboratories Limited | Mylan Laboratories Limited | 国药准字HJ20250098 | 2025/08/19 | 0.25g | Generic approved under the new chemical-drug registration classification | CDE |
| Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized | Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized | 国药准字H20080642 | 2024/05/10 | 0.25g | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Zhejiang Jian Feng Pharma Co., Ltd. romanized | Zhejiang Jian Feng Pharma Co., Ltd. romanized | 国药准字H20070267 | 2023/09/12 | 0.25g | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| NORTH CHINA PHARMACEUTICAL COMPANY.LTD | NORTH CHINA PHARMACEUTICAL COMPANY.LTD | 国药准字H20080297 | 2022/12/07 | 0.25g | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20223441 | 2022/06/28 | 0.25g | Generic approved under the new chemical-drug registration classification | CDE |
| HUNAN WARRANT PHARMACEUTICAL CO.,LTD | HUNAN WARRANT PHARMACEUTICAL CO.,LTD | 国药准字H20080016 | 2022/03/08 | 0.25g | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Hainan Xian Sheng Pharma Co., Ltd. romanized | Hainan Xian Sheng Pharma Co., Ltd. romanized | 国药准字H20213150 | — | 0.25g | Generic approved under the new chemical-drug registration classification | CDE |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H20080003 | 2020/12/23 | 0.25g | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Qiong Lai Tian Yin Pharmaceutical Co., Ltd. romanized | Qiong Lai Tian Yin Pharmaceutical Co., Ltd. romanized | 国药准字H20080819 | 2020/12/03 | 0.25g | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Han Hui Pharmaceutical Co., Ltd. romanized | Zhejiang Hai Zheng Pharma Co., Ltd. romanized | 国药准字H20070081 | 2020/04/28 | 0.25g | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Name not romanized | Shanghai Luo Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20031240 | 2003/12/12 | 0.25g | Other drug | CDE |
| Roche Registration Ltd. | Roche S.p.A. | H20130363 | 1997/07/24 | 0.25g | 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: 13 distinct approval numbers and 13 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Shanghai Luo Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20031240 | 0.25g | Category B | XL04AAM026E001010100723 | NHSA |
| Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized | 国药准字H20080642 | 0.25g | Category B | XL04AAM026E001010101698 | NHSA |
| Qiong Lai Tian Yin Pharmaceutical Co., Ltd. romanized | 国药准字H20080819 | 0.25g | Category B | XL04AAM026E001010102067 | NHSA |
| NORTH CHINA PHARMACEUTICAL COMPANY.LTD | 国药准字H20080297 | 0.25g | Category B | XL04AAM026E001010102697 | NHSA |
| Shandong Hua Lu Pharmaceutical Co., Ltd. romanized | 国药准字H20100118 | 0.25g | Category B | XL04AAM026E001010104098 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20080764 | 0.25g | Category B | XL04AAM026E001010104127 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20223441 | 0.25g | Category B | XL04AAM026E001010104188 | NHSA |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H20080003 | 0.25g | Category B | XL04AAM026E001010104520 | NHSA |
| Zhejiang Zhang Dian Drug Technology Kai Fa Co., Ltd. romanized | 国药准字H20070081 | 0.25g | Category B | XL04AAM026E001010104641 | NHSA |
| Zhejiang Jian Feng Pharma Co., Ltd. romanized | 国药准字H20070267 | 0.25g | Category B | XL04AAM026E001010104655 | NHSA |
| HUNAN WARRANT PHARMACEUTICAL CO.,LTD | 国药准字H20080016 | 0.25g | Category B | XL04AAM026E001010104929 | NHSA |
| Hainan Xian Sheng Pharma Co., Ltd. romanized | 国药准字H20213150 | 0.25g | Category B | XL04AAM026E001010105849 | NHSA |
| Bei Da Pharmaceuticals Co., Ltd. romanized | 国药准字H20133045 | 250mg | Category B | XL04AAM026E001010109660 | NHSA |
| Shanghai Luo Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20031240 | 0.25g | Category B | XL04AAM026E001010200723 | NHSA |
| Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized | 国药准字H20080642 | 0.25g | Category B | XL04AAM026E001010201698 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20080764 | 0.25g | Category B | XL04AAM026E001010204127 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20223441 | 0.25g | Category B | XL04AAM026E001010204188 | NHSA |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H20080003 | 0.25g | Category B | XL04AAM026E001010204520 | NHSA |
| Zhejiang Zhang Dian Drug Technology Kai Fa Co., Ltd. romanized | 国药准字H20070081 | 0.25g | Category B | XL04AAM026E001010204641 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20223441 | 0.25g | Category B | XL04AAM026E001010304188 | NHSA |
| Zhejiang Zhang Dian Drug Technology Kai Fa Co., Ltd. romanized | 国药准字H20070081 | 0.25g | Category B | XL04AAM026E001010304641 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20223441 | 0.25g | Category B | XL04AAM026E001010404188 | NHSA |
| Zhejiang Zhang Dian Drug Technology Kai Fa Co., Ltd. romanized | 国药准字H20070081 | 0.25g | Category B | XL04AAM026E001010404641 | NHSA |
| Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 国药准字H20223441 | 0.25g | Category B | XL04AAM026E001010504188 | NHSA |
| Zhejiang Zhang Dian Drug Technology Kai Fa Co., Ltd. romanized | 国药准字H20070081 | 0.25g | Category B | XL04AAM026E001010504641 | NHSA |
| HUNAN WARRANT PHARMACEUTICAL CO.,LTD | 国药准字H20080016 | 0.25g | Category B | XL04AAM026E001020104929 | NHSA |
| HUNAN WARRANT PHARMACEUTICAL CO.,LTD | 国药准字H20080016 | 0.25g | Category B | XL04AAM026E001020204929 | 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 4 distinct first applicants.
Generic 2 · Supplement 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Zhejiang Nord Pharmaceutical Co., Ltd | CYHS2600006 | Generic | 2026/01/05 | Not stated by source | CDE |
| Shanghai Luo Shi Pharmaceutical Co., Ltd. romanized | CYHB2601769 | Supplement | 2026/09/20 | Not stated by source | CDE |
| Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | CYHS2601858 | Generic | 2026/08/03 | Not stated by source | CDE |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | CYHB2602033 | Supplement | 2026/11/09 | 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 |
|---|---|---|---|---|---|
| Zhejiang Nord Pharmaceutical Co., Ltd | CYHS2600006 | Generic | 2026/01/05 | Not stated by source | CDE |
| Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | CYHS2601858 | Generic | 2026/08/03 | Not stated by source | CDE |
Non-component matches: 28 companies with A status and 1 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 |
|---|---|---|---|---|---|---|
| 吗替麦考酚酯 · No verified English name | Biocon Limited | Y20240001442 | I | Exact ingredient | 2025/05/16 | CDE |
| 吗替麦考酚酯 · No verified English name | Concord Biotech Limited | Y20210000932 | A | Exact ingredient | 2024/11/09 | CDE |
| 吗替麦考酚酯 · No verified English name | Roche Pharma (Schweiz) AG | Y20190000656 | A | Exact ingredient | 2026/06/16 | CDE |
| 吗替麦考酚酯 · No verified English name | Roche Pharma (Schweiz) Ltd. | Y20190009938 | A | Exact ingredient | — | CDE |
| 吗替麦考酚酯 · No verified English name | Roche Pharma (Schweiz) Ltd. | Y20190009937 | A | Exact ingredient | — | CDE |
| 吗替麦考酚酯 · No verified English name | Hai Zheng Pharma (Hangzhou) Co., Ltd. romanized | Y20190009807 | A | Exact ingredient | — | CDE |
| 吗替麦考酚酯 · No verified English name | Guo Yao Group Chuan Kang Pharmaceutical Co., Ltd. romanized | Y20190009643 | A | Exact ingredient | 2025/09/27 | CDE |
| 吗替麦考酚酯 · No verified English name | Wuxi Fu Qi Pharmaceutical Co., Ltd. romanized | Y20190008682 | A | Exact ingredient | 2026/07/10 | CDE |
| 吗替麦考酚酯 · No verified English name | Fujian Ke Rui Pharma Co., Ltd. romanized | Y20190008499 | A | Exact ingredient | 2024/09/04 | CDE |
| 吗替麦考酚酯 · No verified English name | Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | Y20190007112 | A | Exact ingredient | 2023/03/24 | CDE |
| 吗替麦考酚酯 · No verified English name | Li Zhu Group Xin Bei Jiang Pharmaceutical Co., Ltd. romanized | Y20190006954 | A | Exact ingredient | 2023/03/24 | CDE |
| 吗替麦考酚酯 · No verified English name | Nanjing Jing Lun Pharmaceutical Co., Ltd. romanized | Y20190006521 | A | Exact ingredient | — | CDE |
| 吗替麦考酚酯 · No verified English name | Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized | Y20190006157 | A | Exact ingredient | 2026/02/25 | CDE |
| 吗替麦考酚酯 · No verified English name | Hubei Wu Shi Pharma Co., Ltd. romanized | Y20190006087 | A | Exact ingredient | 2025/12/24 | CDE |
| 吗替麦考酚酯 · No verified English name | Ji Chuan Pharma Group Co., Ltd. romanized | Y20190006082 | A | Exact ingredient | — | CDE |
| 吗替麦考酚酯 · No verified English name | Shandong Chen Long Pharma Co., Ltd. romanized | Y20190005848 | A | Exact ingredient | 2024/02/08 | CDE |
| 吗替麦考酚酯 · No verified English name | Chongqing Lai Mei Long Yu Pharma Co., Ltd. romanized | Y20190005179 | A | Exact ingredient | 2025/06/05 | CDE |
| 吗替麦考酚酯 · No verified English name | Fuzhou Hai Wang Fu Yao Pharmaceutical Co., Ltd. romanized | Y20190005113 | A | Exact ingredient | — | CDE |
| 吗替麦考酚酯 · No verified English name | Hebei Bai Qi Pharma Co., Ltd. romanized | Y20190004938 | A | Exact ingredient | — | CDE |
| 吗替麦考酚酯 · No verified English name | Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized | Y20190004770 | A | Exact ingredient | 2025/06/28 | CDE |
| 吗替麦考酚酯 · No verified English name | Hua Bei Pharmaceutical Hua Sheng Co., Ltd. romanized | Y20190004299 | A | Exact ingredient | 2024/12/31 | CDE |
| 吗替麦考酚酯 · No verified English name | Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized | Y20190004067 | A | Exact ingredient | — | CDE |
| 吗替麦考酚酯 · No verified English name | Hubei Tian Yi Pharma Co., Ltd. romanized | Y20190004056 | A | Exact ingredient | 2026/05/20 | CDE |
| 吗替麦考酚酯 · No verified English name | Hunan Hua Na Da Pharmaceutical Factory Shou Xing Drug Co., Ltd. romanized | Y20190004030 | A | Exact ingredient | 2025/12/19 | CDE |
| 吗替麦考酚酯 · No verified English name | Jiangsu Shen Long Pharma Co., Ltd. romanized | Y20190003083 | A | Exact ingredient | — | CDE |
| 吗替麦考酚酯 · No verified English name | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20190002063 | A | Exact ingredient | 2025/01/11 | CDE |
| 吗替麦考酚酯 · No verified English name | Jiangsu Jiu Yang Biopharmaceutical Co., Ltd. romanized | Y20190001419 | A | Exact ingredient | 2026/10/29 | CDE |
| 吗替麦考酚酯 · No verified English name | Chongqing Xin Da Xin Pharma Co., Ltd. romanized | Y20190001329 | A | Exact ingredient | 2026/05/20 | CDE |
| 吗替麦考酚酯 · No verified English name | Hua Run San Jiu (Tang Shan) Pharma Co., Ltd. romanized | Y20190001226 | A | Exact ingredient | 2024/04/11 | CDE |
| 吗替麦考酚酯 · No verified English name | Hai Zheng Pharma (Hangzhou) Co., Ltd. romanized | Y20180000985 | A | Exact ingredient | 2024/12/07 | CDE |
| 吗替麦考酚酯 · No verified English name | Roche Pharma (Schweiz) Ltd. | Y20170002082 | A | Exact ingredient | — | CDE |
| 吗替麦考酚酯 · No verified English name | Shanghai Luo Shi Pharmaceutical Co., Ltd. romanized | Y20170001961 | A | Exact ingredient | 2019/01/14 | CDE |
| 吗替麦考酚酯 · No verified English name | Guo Yao Group Chuan Kang Pharmaceutical Co., Ltd. romanized | Y20170001960 | A | Exact ingredient | 2022/11/08 | 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.
CYHB2602033
Fact date: 2026/11/09 · Site observation date: 2026/11/10
View source ↗CYHB2601769
Fact date: 2026/09/20 · 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.
Free follow
Up to 3 drugs per email address, in one weekly digest. Starts after email confirmation; unsubscribe at any time.
Subscriptions
US$200
Billed every month
Sign in to subscribeUS$540
Billed every three months
US$180 per month
Sign in to subscribeUS$1,920
Billed every year
US$160 per month
Sign in to subscribeSeparate one-time purchase
Full table and CSV export for 12 months from payment, with monthly data updates. No automatic renewal.
Subscriptions and comparison-table access are purchased separately. Neither includes the other.
Billed by Creem, our merchant of record · Terms · Refund policy