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Sign in to subscribeAs of 13 November 2026, for Finerenone Tablets, 69 applications are listed as under review at China's CDE; 11 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 5 holders.
Companies, stages and changes, with each record available on this page.
Listed in the US FDA Orange Book as KERENDIA (NDA 215341, BAYER HEALTHCARE PHARMACEUTICALS INC).
Last 90 days: Accepted: 5 applicationsNo longer listed under review: 4 applicationsApproval-document delivery record: 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 |
|---|---|---|---|---|---|---|
| KERENDIA | BAYER HEALTHCARE PHARMACEUTICALS INC | NDA 215341 · Product no. 001, 002 | TABLET | ORAL | HUMAN PRESCRIPTION DRUG | 2021/07/09 |
| KERENDIA | BAYER HEALTHCARE PHARMACEUTICALS INC | NDA 215341 · Product no. 003 | TABLET | ORAL | HUMAN PRESCRIPTION DRUG | 2025/07/11 |
No listings in this group among the displayed brand names.
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: 5 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 4 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 |
|---|---|---|---|---|---|---|
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20264202 | 2026/04/29 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20263813 | 2026/03/31 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20263814 | 2026/03/31 | 20mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized | Hunan Jiudian Pharmaceutical Co., Ltd | 国药准字H20263696 | 2026/03/25 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20256074 | 2025/11/25 | 10mg | Generic approved under the new chemical-drug registration classification | CDE |
| Bayer AG | Bayer AG | 国药准字HJ20220057 | 2022/06/28 | 10mg | Imported originator drug | CDE |
| Bayer AG | Bayer AG | 国药准字HJ20220058 | 2022/06/28 | 20mg | 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: 7 distinct approval numbers and 5 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20256074 | 10mg | Category B | XC03DAF731A001010105001 | NHSA |
| Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized | 国药准字H20263813 | 10mg | Category B | XC03DAF731A001010105332 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20264202 | 20mg | Category B | XC03DAF731A001010106632 | NHSA |
| Bayer AG | 国药准字HJ20220057 | 10mg | Category B | XC03DAF731A001010178262 | NHSA |
| Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263696 | 10mg | Category B | XC03DAF731A001010183916 | NHSA |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20256074 | 10mg | Category B | XC03DAF731A001010205001 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20264202 | 20mg | Category B | XC03DAF731A001010206632 | NHSA |
| Bayer AG | 国药准字HJ20220057 | 10mg | Category B | XC03DAF731A001010278262 | NHSA |
| Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263696 | 10mg | Category B | XC03DAF731A001010283916 | NHSA |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20256074 | 10mg | Category B | XC03DAF731A001010305001 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20264202 | 20mg | Category B | XC03DAF731A001010306632 | NHSA |
| Bayer AG | 国药准字HJ20220057 | 10mg | Category B | XC03DAF731A001010378262 | NHSA |
| Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263696 | 10mg | Category B | XC03DAF731A001010383916 | NHSA |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20256074 | 10mg | Category B | XC03DAF731A001010405001 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20264202 | 20mg | Category B | XC03DAF731A001010406632 | NHSA |
| Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263696 | 10mg | Category B | XC03DAF731A001010483916 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20264202 | 20mg | Category B | XC03DAF731A001010506632 | NHSA |
| Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263696 | 10mg | Category B | XC03DAF731A001010583916 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20264202 | 20mg | Category B | XC03DAF731A001010606632 | NHSA |
| Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263696 | 10mg | Category B | XC03DAF731A001010683916 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20264202 | 20mg | Category B | XC03DAF731A001010706632 | NHSA |
| Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized | 国药准字H20263814 | 20mg | Category B | XC03DAF731A001020105332 | NHSA |
| Bayer AG | 国药准字HJ20220058 | 20mg | Category B | XC03DAF731A001020178262 | NHSA |
| Bayer AG | 国药准字HJ20220058 | 20mg | Category B | XC03DAF731A001020278262 | NHSA |
| Bayer AG | 国药准字HJ20220058 | 20mg | Category B | XC03DAF731A001020378262 | 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: 69 filings and 45 distinct first applicants.
Generic 62 · Supplement 3 · Import 2 · Import re-registration 2
Loaded records: 17 filings and 11 distinct first applicants.
Non-component matches: 16 companies with A status and 34 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 |
|---|---|---|---|---|---|---|
| 非奈利酮 · No verified English name | Nei Menggu Ge Lin Te Pharmaceutical Co., Ltd. romanized | Y20260000839 | I | Exact ingredient | 2026/10/09 | CDE |
| 非奈利酮 · No verified English name | Shandong Chen Long Pharma Co., Ltd. romanized | Y20260000689 | I | Exact ingredient | 2026/08/07 | CDE |
| 非奈利酮 · No verified English name | Sichuan Guang An Tian Xing Pharmaceutical Co., Ltd. romanized | Y20260000655 | I | Exact ingredient | 2026/07/30 | CDE |
| 非奈利酮 · No verified English name | Zhejiang Shen Zhou Pharma Co., Ltd. romanized | Y20260000530 | I | Exact ingredient | 2026/07/10 | CDE |
| 非奈利酮 · No verified English name | Shandong An Xin Pharmaceutical Co., Ltd. romanized | Y20260000440 | I | Exact ingredient | 2026/06/04 | CDE |
| 非奈利酮 · No verified English name | Zhong Shan Bai Sheng Bio Technology Co., Ltd. romanized | Y20260000333 | I | Exact ingredient | 2026/04/30 | CDE |
| 非奈利酮 · No verified English name | Zhejiang Mei Nuo Hua Drug Chemical Co., Ltd. romanized | Y20260000194 | I | Exact ingredient | 2026/04/28 | CDE |
| 非奈利酮 · No verified English name | Sui Cheng Pharma Co., Ltd. romanized | Y20260000288 | I | Exact ingredient | 2026/04/13 | CDE |
| 非奈利酮 · No verified English name | Hunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanized | Y20260000102 | I | Exact ingredient | 2026/02/27 | CDE |
| 非奈利酮 · No verified English name | Hefei Li Fang Pharmaceutical Co., Ltd. romanized | Y20260000042 | I | Exact ingredient | 2026/02/09 | CDE |
| 非奈利酮 · No verified English name | Yi Chang Dong Yang Guang Pharmaceutical Co., Ltd. romanized | Y20260000085 | I | Exact ingredient | 2026/02/09 | CDE |
| 非奈利酮 · No verified English name | Yang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanized | Y20250001159 | I | Exact ingredient | 2026/01/21 | CDE |
| 非奈利酮 · No verified English name | Liaoning Bei Feng Pharma Co., Ltd. romanized | Y20250001485 | I | Exact ingredient | 2026/01/20 | CDE |
| 非奈利酮 · No verified English name | Gan Li Pharma Shandong Co., Ltd. romanized | Y20250001128 | I | Exact ingredient | 2026/01/09 | CDE |
| 非奈利酮 · No verified English name | Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized | Y20250001366 | I | Exact ingredient | 2026/01/09 | CDE |
| 非奈利酮 · No verified English name | Changzhou Shi Yang Guang Pharma Co., Ltd. romanized | Y20250001089 | I | Exact ingredient | 2025/11/18 | CDE |
| 非奈利酮 · No verified English name | Shandong Rui Shun Pharma Co., Ltd. romanized | Y20250001131 | I | Exact ingredient | 2025/11/12 | CDE |
| 非奈利酮 · No verified English name | Jiangsu Run An Pharmaceutical Co., Ltd. romanized | Y20250001189 | I | Exact ingredient | 2025/11/11 | CDE |
| 非奈利酮 · No verified English name | Shandong Jin Cheng Kun Lun Pharma Co., Ltd. romanized | Y20250000433 | I | Exact ingredient | 2025/10/15 | CDE |
| 非奈利酮 · No verified English name | Zhejiang Hua Hai Jian Cheng Pharma Co., Ltd. romanized | Y20250000980 | I | Exact ingredient | 2025/10/11 | CDE |
| 非奈利酮 · No verified English name | Shandong Cheng Hui Shuang Da Pharma Co., Ltd. romanized | Y20250000977 | I | Exact ingredient | 2025/09/17 | CDE |
| 非奈利酮 · No verified English name | Jiangxi Ke Rui Pharma Co., Ltd. romanized | Y20250000942 | I | Exact ingredient | 2025/09/08 | CDE |
| 非奈利酮 · No verified English name | Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | Y20250000909 | I | Exact ingredient | 2025/09/05 | CDE |
| 非奈利酮 · No verified English name | Yi Chang Tian Ren Pharma Co., Ltd. romanized | Y20250000755 | I | Exact ingredient | 2025/08/22 | CDE |
| 非奈利酮 · No verified English name | Zhejiang Jing Sheng Pharma Co., Ltd. romanized | Y20250000767 | I | Exact ingredient | 2025/07/31 | CDE |
| 非奈利酮 · No verified English name | Cang Zhou Wei Zhi Da Mei Pharmaceutical Co., Ltd. romanized | Y20250000737 | I | Exact ingredient | 2025/07/31 | CDE |
| 非奈利酮 · No verified English name | Shandong Ke Chao Biopharmaceutical Co., Ltd. romanized | Y20250000511 | I | Exact ingredient | 2025/07/08 | CDE |
| 非奈利酮 · No verified English name | Anhui Ai Li De Pharmaceutical Co., Ltd. romanized | Y20250000609 | I | Exact ingredient | 2025/07/03 | CDE |
| 非奈利酮 · No verified English name | Wu Yi Ci Hang Pharma Co., Ltd. romanized | Y20250000558 | I | Exact ingredient | 2025/06/09 | CDE |
| 非奈利酮 · No verified English name | Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized | Y20250000512 | I | Exact ingredient | 2025/06/04 | CDE |
| 非奈利酮 · No verified English name | Xin Xiang Shuang Lu Pharma Co., Ltd. romanized | Y20250000434 | I | Exact ingredient | 2025/05/27 | CDE |
| 非奈利酮 · No verified English name | Topfond Pharmaceutical Co., Ltd. | Y20250000457 | I | Exact ingredient | 2025/05/27 | CDE |
| 非奈利酮 · No verified English name | Shanghai Di Sai Nuo Chemical Pharmaceutical Co., Ltd. romanized | Y20250000403 | I | Exact ingredient | 2025/05/12 | CDE |
| 非奈利酮 · No verified English name | Sichuan Kelun Pharmaceutical Co., Ltd. | Y20250000371 | A | Exact ingredient | 2026/09/16 | CDE |
| 非奈利酮 · No verified English name | Shandong Lukang Pharmaceutical Co.,Ltd. | Y20250000245 | I | Exact ingredient | 2025/04/15 | CDE |
| 非奈利酮 · No verified English name | Ao Rui Te Pharma Co., Ltd. romanized | Y20250000120 | A | Exact ingredient | 2026/07/21 | CDE |
| 非奈利酮 · No verified English name | Zhejiang Le Pu Pharma Co., Ltd. romanized | Y20250000132 | A | Exact ingredient | 2026/09/13 | CDE |
| 非奈利酮 · No verified English name | Chongqing Sheng Kai Pharmaceutical Co., Ltd. romanized | Y20240001451 | A | Exact ingredient | 2026/07/21 | CDE |
| 非奈利酮 · No verified English name | Hubei Tian Shu Pharma Co., Ltd. romanized | Y20240001505 | A | Exact ingredient | 2026/09/21 | CDE |
| 非奈利酮 · No verified English name | Chongqing Lai Mei Long Yu Pharma Co., Ltd. romanized | Y20240001478 | A | Exact ingredient | 2026/09/10 | CDE |
| 非奈利酮 · No verified English name | Xu Zhou Wan Bang Jin Qiao Pharmaceutical Co., Ltd. romanized | Y20240001497 | A | Exact ingredient | 2026/06/17 | CDE |
| 非奈利酮 · No verified English name | Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | Y20240001327 | A | Exact ingredient | 2026/07/14 | CDE |
| 非奈利酮 · No verified English name | Zhejiang Hai Zheng Pharma Co., Ltd. romanized | Y20240001229 | A | Exact ingredient | 2026/09/17 | CDE |
| 非奈利酮 · No verified English name | Wan Yang Heng Shui Pharmaceutical Co., Ltd. romanized | Y20240001148 | A | Exact ingredient | 2026/03/13 | CDE |
| 非奈利酮 · No verified English name | Chongqing Kai Lin Pharmaceutical Co., Ltd. romanized | Y20240000712 | A | Exact ingredient | 2026/06/01 | CDE |
| 非奈利酮 · No verified English name | Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | Y20240000913 | A | Exact ingredient | 2026/03/26 | CDE |
| 非奈利酮 · No verified English name | Nan Tong Chang You Pharma Technology Co., Ltd. romanized | Y20240000768 | A | Exact ingredient | 2026/02/09 | CDE |
| 非奈利酮 · No verified English name | Hebei Guo Long Pharmaceutical Co., Ltd. romanized | Y20240000862 | A | Exact ingredient | 2026/07/15 | CDE |
| 非奈利酮 · No verified English name | Suzhou Zheng Ji Pharma Co., Ltd. romanized | Y20240000782 | A | Exact ingredient | 2026/04/14 | CDE |
| 非奈利酮 · No verified English name | Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | Y20230001187 | A | Exact ingredient | 2025/09/16 | 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.
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.
JTH2600221
Fact date: 2026/11/13 · Site observation date: 2026/11/13
Accepted: 2026/10/23
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗JTH2600220
Fact date: 2026/11/13 · Site observation date: 2026/11/13
Accepted: 2026/10/23
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗JTH2600200
Fact date: 2026/10/23 · Site observation date: 2026/10/23
Accepted: 2026/09/22
not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/10/23 (approval no.: —; approval date: 2026/10/21) · NMPA source · row 157
NMPA · Table row 157 ↗ View source ↗JTH2600199
Fact date: 2026/10/23 · Site observation date: 2026/10/23
Accepted: 2026/09/22
not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/10/23 (approval no.: —; approval date: 2026/10/21) · NMPA source · row 156
NMPA · Table row 156 ↗ View source ↗JTH2600221
Fact date: 2026/10/23 · Site observation date: 2026/10/24
View source ↗JTH2600220
Fact date: 2026/10/23 · Site observation date: 2026/10/24
View source ↗JTH2600200
Fact date: 2026/10/21 · Publication date: 2026/10/23 · Site observation date: 2026/11/03
View source · Table row 157 ↗JTH2600199
Fact date: 2026/10/21 · Publication date: 2026/10/23 · Site observation date: 2026/11/03
View source · Table row 156 ↗JTH2600200
Fact date: 2026/09/22 · Site observation date: 2026/10/22
View source ↗JTH2600199
Fact date: 2026/09/22 · Site observation date: 2026/10/22
View source ↗CYHB2601557
Fact date: 2026/08/17 · 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.
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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