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Public drug landscapesDrug landscape

Finerenone Tablets

As 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).

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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
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

Other dosage forms of the same ingredient

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.

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: 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 holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Jiangsu Deyuan Pharmaceutical Co.,Ltd.Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H202642022026/04/2920mgGeneric approved under the new chemical-drug registration classificationCDE
Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanizedShandong Lang Nuo Pharmaceutical Co., Ltd. romanized国药准字H202638132026/03/3110mgGeneric approved under the new chemical-drug registration classificationCDE
Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanizedShandong Lang Nuo Pharmaceutical Co., Ltd. romanized国药准字H202638142026/03/3120mgGeneric approved under the new chemical-drug registration classificationCDE
Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanizedHunan Jiudian Pharmaceutical Co., Ltd国药准字H202636962026/03/2510mgGeneric approved under the new chemical-drug registration classificationCDE
Hunan Ming Rui Pharmaceutical Co., Ltd. romanizedHunan Ming Rui Pharmaceutical Co., Ltd. romanized国药准字H202560742025/11/2510mgGeneric approved under the new chemical-drug registration classificationCDE
Bayer AGBayer AG国药准字HJ202200572022/06/2810mgImported originator drugCDE
Bayer AGBayer AG国药准字HJ202200582022/06/2820mgImported 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: 7 distinct approval numbers and 5 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Hunan Ming Rui Pharmaceutical Co., Ltd. romanized国药准字H2025607410mgCategory BXC03DAF731A001010105001NHSA
Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized国药准字H2026381310mgCategory BXC03DAF731A001010105332NHSA
Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H2026420220mgCategory BXC03DAF731A001010106632NHSA
Bayer AG国药准字HJ2022005710mgCategory BXC03DAF731A001010178262NHSA
Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized国药准字H2026369610mgCategory BXC03DAF731A001010183916NHSA
Hunan Ming Rui Pharmaceutical Co., Ltd. romanized国药准字H2025607410mgCategory BXC03DAF731A001010205001NHSA
Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H2026420220mgCategory BXC03DAF731A001010206632NHSA
Bayer AG国药准字HJ2022005710mgCategory BXC03DAF731A001010278262NHSA
Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized国药准字H2026369610mgCategory BXC03DAF731A001010283916NHSA
Hunan Ming Rui Pharmaceutical Co., Ltd. romanized国药准字H2025607410mgCategory BXC03DAF731A001010305001NHSA
Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H2026420220mgCategory BXC03DAF731A001010306632NHSA
Bayer AG国药准字HJ2022005710mgCategory BXC03DAF731A001010378262NHSA
Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized国药准字H2026369610mgCategory BXC03DAF731A001010383916NHSA
Hunan Ming Rui Pharmaceutical Co., Ltd. romanized国药准字H2025607410mgCategory BXC03DAF731A001010405001NHSA
Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H2026420220mgCategory BXC03DAF731A001010406632NHSA
Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized国药准字H2026369610mgCategory BXC03DAF731A001010483916NHSA
Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H2026420220mgCategory BXC03DAF731A001010506632NHSA
Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized国药准字H2026369610mgCategory BXC03DAF731A001010583916NHSA
Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H2026420220mgCategory BXC03DAF731A001010606632NHSA
Hunan Hui Ze Biopharmaceuticals Technology Co., Ltd. romanized国药准字H2026369610mgCategory BXC03DAF731A001010683916NHSA
Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H2026420220mgCategory BXC03DAF731A001010706632NHSA
Jiangxi Pu Zheng Pharmaceutical Co., Ltd. romanized国药准字H2026381420mgCategory BXC03DAF731A001020105332NHSA
Bayer AG国药准字HJ2022005820mgCategory BXC03DAF731A001020178262NHSA
Bayer AG国药准字HJ2022005820mgCategory BXC03DAF731A001020278262NHSA
Bayer AG国药准字HJ2022005820mgCategory BXC03DAF731A001020378262NHSA

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: 69 filings and 45 distinct first applicants.

Generic 62 · Supplement 3 · Import 2 · Import re-registration 2

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Zhejiang Nord Pharmaceutical Co., LtdCYHS2601070Generic2026/05/12Not stated by sourceCDE
Shandong Lukang Pharmaceutical Co.,Ltd.CYHS2502708Generic2025/07/28Not stated by sourceCDE
Shandong Lukang Pharmaceutical Co.,Ltd.CYHS2502707Generic2025/07/28Not stated by sourceCDE
Nanjing Hai Na Pharmaceutical Co., Ltd. romanizedCYHS2503393Generic2025/09/13Not stated by sourceCDE
Wuxi Kai Fu Pharmaceutical Co., Ltd. romanized; Jiangsu Cheng Kang Pharma Co., Ltd. romanizedCYHS2503826Generic2025/10/29Not stated by sourceCDE
Wuxi Kai Fu Pharmaceutical Co., Ltd. romanized; Jiangsu Cheng Kang Pharma Co., Ltd. romanizedCYHS2503825Generic2025/10/29Not stated by sourceCDE
Jiangsu Cheng Kang Pharma Co., Ltd. romanizedCYHS2501400Generic2025/04/11Not stated by sourceCDE
Jiangsu Cheng Kang Pharma Co., Ltd. romanizedCYHS2501399Generic2025/04/11Not stated by sourceCDE
Changzhou Pharmaceutical Factory Co., Ltd. romanizedCYHS2600107Generic2026/01/09Not stated by sourceCDE
Changzhou Pharmaceutical Factory Co., Ltd. romanizedCYHS2600106Generic2026/01/09Not stated by sourceCDE
Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanizedCYHS2502822Generic2025/08/05Not stated by sourceCDE
Nan Tong Lian Ya Pharma Co., Ltd. romanizedCYHS2504451Generic2025/12/26Not stated by sourceCDE
Changzhou Shi Yang Guang Pharma Co., Ltd. romanizedCYHS2504310Generic2025/12/18Not stated by sourceCDE
Changzhou Shi Yang Guang Pharma Co., Ltd. romanizedCYHS2504309Generic2025/12/18Not stated by sourceCDE
Henan Zhong Jie Pharma Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanizedCYHB2601557Supplement2026/08/17Not stated by sourceCDE
Bayer AG; Bayer Healthcare Company Ltd.JXHS2600089Import2026/08/13Not stated by sourceCDE
Bayer AG; Bayer Healthcare Company Ltd.JXHS2600088Import2026/08/13Not stated by sourceCDE
Bayer AG; Bayer Healthcare Company Ltd.JYHZ2600161Import re-registration2026/07/06Not stated by sourceCDE
Bayer AG; Bayer Healthcare Company Ltd.JYHZ2600160Import re-registration2026/07/06Not stated by sourceCDE
Fujian Dong Rui Pharmaceutical Co., Ltd. romanizedCYHS2600843Generic2026/04/11Not stated by sourceCDE
Yun Peng Pharmaceuticals Group Co., Ltd. romanized; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanizedCYHB2600609Supplement2026/03/27Not stated by sourceCDE
Yun Peng Pharmaceuticals Group Co., Ltd. romanized; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanizedCYHB2600608Supplement2026/03/27Not stated by sourceCDE
Hebei Tian Cheng Pharma Co., Ltd. romanizedCYHS2600656Generic2026/03/13Not stated by sourceCDE
TIANJIN LISHENG PHARMACEUTICAL CO., LTDCYHS2600608Generic2026/03/04Not stated by sourceCDE
TIANJIN LISHENG PHARMACEUTICAL CO., LTDCYHS2600607Generic2026/03/04Not stated by sourceCDE
Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanizedCYHS2600567Generic2026/02/27Not stated by sourceCDE
Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCYHS2600466Generic2026/02/13Not stated by sourceCDE
Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCYHS2600464Generic2026/02/13Not stated by sourceCDE
Shaanxi Jun Ke Li Pharmaceuticals Technology Co., Ltd. romanized; Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanizedCYHS2600289Generic2026/01/28Not stated by sourceCDE
Shaanxi Jun Ke Li Pharmaceuticals Technology Co., Ltd. romanized; Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanizedCYHS2600288Generic2026/01/28Not stated by sourceCDE
Gan Li Pharma Shandong Co., Ltd. romanizedCYHS2600222Generic2026/01/20Not stated by sourceCDE
Zhejiang Wei Kang Pharmaceutical Co., Ltd. romanizedCYHS2600091Generic2026/01/08Not stated by sourceCDE
Shandong Ze Yu Bio Co., Ltd. romanizedCYHS2600018Generic2026/01/05Not stated by sourceCDE
Sichuan Yi Sheng Zhi Tong Pharmaceuticals Bio Technology Development Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanizedCYHS2504482Generic2025/12/30Not stated by sourceCDE
Zhejiang Hai Zheng Pharma Co., Ltd. romanizedCYHS2504299Generic2025/12/17Not stated by sourceCDE
Shanghai Shyndec Pharmaceutical Co., Ltd.CYHS2504224Generic2025/12/09Not stated by sourceCDE
Tian Da Pharma (Zhuhai) Co., Ltd. romanizedCYHS2504216Generic2025/12/09Not stated by sourceCDE
Tian Da Pharma (Zhuhai) Co., Ltd. romanizedCYHS2504214Generic2025/12/09Not stated by sourceCDE
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanizedCYHS2504169Generic2025/12/04Not stated by sourceCDE
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanizedCYHS2504168Generic2025/12/04Not stated by sourceCDE
Jiangxi Ke Rui Pharma Co., Ltd. romanizedCYHS2503911Generic2025/11/08Not stated by sourceCDE
Sui Cheng Pharma Co., Ltd. romanizedCYHS2503909Generic2025/11/08Not stated by sourceCDE
Sui Cheng Pharma Co., Ltd. romanizedCYHS2503908Generic2025/11/08Not stated by sourceCDE
Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanizedCYHS2503802Generic2025/10/28Not stated by sourceCDE
Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanizedCYHS2503801Generic2025/10/28Not stated by sourceCDE
Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanizedCYHS2503781Generic2025/10/24Not stated by sourceCDE
Su Zhou Yi Fan Pharma Co., Ltd. romanizedCYHS2503668Generic2025/10/14Not stated by sourceCDE
Su Zhou Yi Fan Pharma Co., Ltd. romanizedCYHS2503667Generic2025/10/14Not stated by sourceCDE
Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.CYHS2503333Generic2025/09/09Not stated by sourceCDE
Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.CYHS2503332Generic2025/09/09Not stated by sourceCDE
Anhui Wan Bang Pharmaceuticals Technology Co., Ltd. romanized; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanizedCYHS2503245Generic2025/09/03Not stated by sourceCDE
Anhui Wan Bang Pharmaceuticals Technology Co., Ltd. romanized; Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanizedCYHS2503244Generic2025/09/03Not stated by sourceCDE
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanizedCYHS2503019Generic2025/08/19Not stated by sourceCDE
Chongqing Lai Mei Pharma Co., Ltd. romanizedCYHS2502931Generic2025/08/12Not stated by sourceCDE
Zhejiang Bei De Pharma Co., Ltd. romanizedCYHS2502889Generic2025/08/09Not stated by sourceCDE
Zhejiang Bei De Pharma Co., Ltd. romanizedCYHS2502888Generic2025/08/09Not stated by sourceCDE
Jiangxi Ke Lun Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.CYHS2502783Generic2025/08/02Not stated by sourceCDE
Jiangxi Ke Lun Pharma Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd.CYHS2502781Generic2025/08/02Not stated by sourceCDE
Zhongshan Wanhan Pharmaceuticals Co., Ltd.CYHS2502654Generic2025/07/23Not stated by sourceCDE
Zhongshan Wanhan Pharmaceuticals Co., Ltd.CYHS2502653Generic2025/07/23Not stated by sourceCDE
Shijiazhuang No.4 Pharmaceutical Co., Ltd.CYHS2502407Generic2025/07/08Not stated by sourceCDE
Guangzhou Da Guang Pharmaceutical Co., Ltd. romanizedCYHS2501561Generic2025/04/25Not stated by sourceCDE
Guangzhou Da Guang Pharmaceutical Co., Ltd. romanizedCYHS2501559Generic2025/04/25Not stated by sourceCDE
Tianjin Han Rui Pharma Co., Ltd. romanizedCYHS2501396Generic2025/04/11Not stated by sourceCDE
Yang Ling Ke Sen Biopharmaceutical Co., Ltd. romanizedCYHS2501256Generic2025/04/03Not stated by sourceCDE
NORTH CHINA PHARMACEUTICAL COMPANY.LTDCYHS2500751Generic2025/02/17Not stated by sourceCDE
Chongqing Huapont Pharmaceutical Co., Ltd.CYHS2500538Generic2025/01/27Not stated by sourceCDE
Chongqing Huapont Pharmaceutical Co., Ltd.CYHS2500537Generic2025/01/27Not stated by sourceCDE
Tian Di Heng Yi Pharmaceutical Co., Ltd. romanizedCYHS2404406Generic2024/12/19Not stated by sourceCDE
New generic filings in 2026

Loaded records: 17 filings and 11 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Zhejiang Nord Pharmaceutical Co., LtdCYHS2601070Generic2026/05/12Not stated by sourceCDE
Changzhou Pharmaceutical Factory Co., Ltd. romanizedCYHS2600107Generic2026/01/09Not stated by sourceCDE
Changzhou Pharmaceutical Factory Co., Ltd. romanizedCYHS2600106Generic2026/01/09Not stated by sourceCDE
Fujian Dong Rui Pharmaceutical Co., Ltd. romanizedCYHS2600843Generic2026/04/11Not stated by sourceCDE
Hebei Tian Cheng Pharma Co., Ltd. romanizedCYHS2600656Generic2026/03/13Not stated by sourceCDE
TIANJIN LISHENG PHARMACEUTICAL CO., LTDCYHS2600608Generic2026/03/04Not stated by sourceCDE
TIANJIN LISHENG PHARMACEUTICAL CO., LTDCYHS2600607Generic2026/03/04Not stated by sourceCDE
Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanizedCYHS2600567Generic2026/02/27Not stated by sourceCDE
Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCYHS2600466Generic2026/02/13Not stated by sourceCDE
Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., LtdCYHS2600464Generic2026/02/13Not stated by sourceCDE
Shaanxi Jun Ke Li Pharmaceuticals Technology Co., Ltd. romanized; Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanizedCYHS2600289Generic2026/01/28Not stated by sourceCDE
Shaanxi Jun Ke Li Pharmaceuticals Technology Co., Ltd. romanized; Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanizedCYHS2600288Generic2026/01/28Not stated by sourceCDE
Gan Li Pharma Shandong Co., Ltd. romanizedCYHS2600222Generic2026/01/20Not stated by sourceCDE
Zhejiang Wei Kang Pharmaceutical Co., Ltd. romanizedCYHS2600091Generic2026/01/08Not stated by sourceCDE
TIANJIN LISHENG PHARMACEUTICAL CO., LTDCYHS2600086Generic2026/01/08Not stated by sourceCDE
TIANJIN LISHENG PHARMACEUTICAL CO., LTDCYHS2600085Generic2026/01/08Not stated by sourceCDE
Shandong Ze Yu Bio Co., Ltd. romanizedCYHS2600018Generic2026/01/05Not stated by sourceCDE
API registrations

Non-component matches: 16 companies with A status and 34 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
非奈利酮 · No verified English nameNei Menggu Ge Lin Te Pharmaceutical Co., Ltd. romanizedY20260000839IExact ingredient2026/10/09CDE
非奈利酮 · No verified English nameShandong Chen Long Pharma Co., Ltd. romanizedY20260000689IExact ingredient2026/08/07CDE
非奈利酮 · No verified English nameSichuan Guang An Tian Xing Pharmaceutical Co., Ltd. romanizedY20260000655IExact ingredient2026/07/30CDE
非奈利酮 · No verified English nameZhejiang Shen Zhou Pharma Co., Ltd. romanizedY20260000530IExact ingredient2026/07/10CDE
非奈利酮 · No verified English nameShandong An Xin Pharmaceutical Co., Ltd. romanizedY20260000440IExact ingredient2026/06/04CDE
非奈利酮 · No verified English nameZhong Shan Bai Sheng Bio Technology Co., Ltd. romanizedY20260000333IExact ingredient2026/04/30CDE
非奈利酮 · No verified English nameZhejiang Mei Nuo Hua Drug Chemical Co., Ltd. romanizedY20260000194IExact ingredient2026/04/28CDE
非奈利酮 · No verified English nameSui Cheng Pharma Co., Ltd. romanizedY20260000288IExact ingredient2026/04/13CDE
非奈利酮 · No verified English nameHunan Fu Rui Biopharmaceuticals Technology Co., Ltd. romanizedY20260000102IExact ingredient2026/02/27CDE
非奈利酮 · No verified English nameHefei Li Fang Pharmaceutical Co., Ltd. romanizedY20260000042IExact ingredient2026/02/09CDE
非奈利酮 · No verified English nameYi Chang Dong Yang Guang Pharmaceutical Co., Ltd. romanizedY20260000085IExact ingredient2026/02/09CDE
非奈利酮 · No verified English nameYang Zi Jiang Pharma Group Jiangsu Hai Ci Bio Pharma Co., Ltd. romanizedY20250001159IExact ingredient2026/01/21CDE
非奈利酮 · No verified English nameLiaoning Bei Feng Pharma Co., Ltd. romanizedY20250001485IExact ingredient2026/01/20CDE
非奈利酮 · No verified English nameGan Li Pharma Shandong Co., Ltd. romanizedY20250001128IExact ingredient2026/01/09CDE
非奈利酮 · No verified English nameHunan Fang Sheng Pharmaceutical Co., Ltd. romanizedY20250001366IExact ingredient2026/01/09CDE
非奈利酮 · No verified English nameChangzhou Shi Yang Guang Pharma Co., Ltd. romanizedY20250001089IExact ingredient2025/11/18CDE
非奈利酮 · No verified English nameShandong Rui Shun Pharma Co., Ltd. romanizedY20250001131IExact ingredient2025/11/12CDE
非奈利酮 · No verified English nameJiangsu Run An Pharmaceutical Co., Ltd. romanizedY20250001189IExact ingredient2025/11/11CDE
非奈利酮 · No verified English nameShandong Jin Cheng Kun Lun Pharma Co., Ltd. romanizedY20250000433IExact ingredient2025/10/15CDE
非奈利酮 · No verified English nameZhejiang Hua Hai Jian Cheng Pharma Co., Ltd. romanizedY20250000980IExact ingredient2025/10/11CDE
非奈利酮 · No verified English nameShandong Cheng Hui Shuang Da Pharma Co., Ltd. romanizedY20250000977IExact ingredient2025/09/17CDE
非奈利酮 · No verified English nameJiangxi Ke Rui Pharma Co., Ltd. romanizedY20250000942IExact ingredient2025/09/08CDE
非奈利酮 · No verified English nameShijiazhuang Long Ze Pharmaceutical Co., Ltd. romanizedY20250000909IExact ingredient2025/09/05CDE
非奈利酮 · No verified English nameYi Chang Tian Ren Pharma Co., Ltd. romanizedY20250000755IExact ingredient2025/08/22CDE
非奈利酮 · No verified English nameZhejiang Jing Sheng Pharma Co., Ltd. romanizedY20250000767IExact ingredient2025/07/31CDE
非奈利酮 · No verified English nameCang Zhou Wei Zhi Da Mei Pharmaceutical Co., Ltd. romanizedY20250000737IExact ingredient2025/07/31CDE
非奈利酮 · No verified English nameShandong Ke Chao Biopharmaceutical Co., Ltd. romanizedY20250000511IExact ingredient2025/07/08CDE
非奈利酮 · No verified English nameAnhui Ai Li De Pharmaceutical Co., Ltd. romanizedY20250000609IExact ingredient2025/07/03CDE
非奈利酮 · No verified English nameWu Yi Ci Hang Pharma Co., Ltd. romanizedY20250000558IExact ingredient2025/06/09CDE
非奈利酮 · No verified English nameJiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanizedY20250000512IExact ingredient2025/06/04CDE
非奈利酮 · No verified English nameXin Xiang Shuang Lu Pharma Co., Ltd. romanizedY20250000434IExact ingredient2025/05/27CDE
非奈利酮 · No verified English nameTopfond Pharmaceutical Co., Ltd.Y20250000457IExact ingredient2025/05/27CDE
非奈利酮 · No verified English nameShanghai Di Sai Nuo Chemical Pharmaceutical Co., Ltd. romanizedY20250000403IExact ingredient2025/05/12CDE
非奈利酮 · No verified English nameSichuan Kelun Pharmaceutical Co., Ltd.Y20250000371AExact ingredient2026/09/16CDE
非奈利酮 · No verified English nameShandong Lukang Pharmaceutical Co.,Ltd.Y20250000245IExact ingredient2025/04/15CDE
非奈利酮 · No verified English nameAo Rui Te Pharma Co., Ltd. romanizedY20250000120AExact ingredient2026/07/21CDE
非奈利酮 · No verified English nameZhejiang Le Pu Pharma Co., Ltd. romanizedY20250000132AExact ingredient2026/09/13CDE
非奈利酮 · No verified English nameChongqing Sheng Kai Pharmaceutical Co., Ltd. romanizedY20240001451AExact ingredient2026/07/21CDE
非奈利酮 · No verified English nameHubei Tian Shu Pharma Co., Ltd. romanizedY20240001505AExact ingredient2026/09/21CDE
非奈利酮 · No verified English nameChongqing Lai Mei Long Yu Pharma Co., Ltd. romanizedY20240001478AExact ingredient2026/09/10CDE
非奈利酮 · No verified English nameXu Zhou Wan Bang Jin Qiao Pharmaceutical Co., Ltd. romanizedY20240001497AExact ingredient2026/06/17CDE
非奈利酮 · No verified English nameLan Xi Ha San Lian Pharmaceutical Co., Ltd. romanizedY20240001327AExact ingredient2026/07/14CDE
非奈利酮 · No verified English nameZhejiang Hai Zheng Pharma Co., Ltd. romanizedY20240001229AExact ingredient2026/09/17CDE
非奈利酮 · No verified English nameWan Yang Heng Shui Pharmaceutical Co., Ltd. romanizedY20240001148AExact ingredient2026/03/13CDE
非奈利酮 · No verified English nameChongqing Kai Lin Pharmaceutical Co., Ltd. romanizedY20240000712AExact ingredient2026/06/01CDE
非奈利酮 · No verified English nameTian Di Heng Yi Pharmaceutical Co., Ltd. romanizedY20240000913AExact ingredient2026/03/26CDE
非奈利酮 · No verified English nameNan Tong Chang You Pharma Technology Co., Ltd. romanizedY20240000768AExact ingredient2026/02/09CDE
非奈利酮 · No verified English nameHebei Guo Long Pharmaceutical Co., Ltd. romanizedY20240000862AExact ingredient2026/07/15CDE
非奈利酮 · No verified English nameSuzhou Zheng Ji Pharma Co., Ltd. romanizedY20240000782AExact ingredient2026/04/14CDE
非奈利酮 · No verified English nameHunan Ming Rui Pharmaceutical Co., Ltd. romanizedY20230001187AExact ingredient2025/09/16CDE

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.

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. 2026/11/13No longer listed under review

    Bayer HealthCare Manufacturing S.r.l.; Bayer AG; Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized

    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 ↗
  2. 2026/11/13No longer listed under review

    Bayer HealthCare Manufacturing S.r.l.; Bayer AG; Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized

    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 ↗
  3. 2026/10/23No longer listed under review

    MSN Laboratories Private Limited Formulation Division Unit-04; Mai Si An Pharma (Shanghai) Co., Ltd. romanized

    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 ↗
  4. 2026/10/23No longer listed under review

    MSN Laboratories Private Limited Formulation Division Unit-04; Mai Si An Pharma (Shanghai) Co., Ltd. romanized

    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 ↗
  5. 2026/10/23Accepted

    Bayer HealthCare Manufacturing S.r.l.; Bayer AG; Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized

    JTH2600221

    Fact date: 2026/10/23 · Site observation date: 2026/10/24

    View source ↗
  6. 2026/10/23Accepted

    Bayer HealthCare Manufacturing S.r.l.; Bayer AG; Bai Er Pharmaceuticals Healthcare Co., Ltd. romanized

    JTH2600220

    Fact date: 2026/10/23 · Site observation date: 2026/10/24

    View source ↗
  7. 2026/10/21Approval-document delivery record

    Mai Si An Pharma (Shanghai) Co., Ltd. romanized

    JTH2600200

    Fact date: 2026/10/21 · Publication date: 2026/10/23 · Site observation date: 2026/11/03

    View source · Table row 157 ↗
  8. 2026/10/21Approval-document delivery record

    Mai Si An Pharma (Shanghai) Co., Ltd. romanized

    JTH2600199

    Fact date: 2026/10/21 · Publication date: 2026/10/23 · Site observation date: 2026/11/03

    View source · Table row 156 ↗
  9. 2026/09/22Accepted

    MSN Laboratories Private Limited Formulation Division Unit-04; Mai Si An Pharma (Shanghai) Co., Ltd. romanized

    JTH2600200

    Fact date: 2026/09/22 · Site observation date: 2026/10/22

    View source ↗
  10. 2026/09/22Accepted

    MSN Laboratories Private Limited Formulation Division Unit-04; Mai Si An Pharma (Shanghai) Co., Ltd. romanized

    JTH2600199

    Fact date: 2026/09/22 · Site observation date: 2026/10/22

    View source ↗
  11. 2026/08/17Accepted

    Henan Zhong Jie Pharma Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized

    CYHB2601557

    Fact date: 2026/08/17 · 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.

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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