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As of 13 November 2026, for Sildenafil Citrate Oral Disintegrating Tablets, 8 applications are listed as under review at China's CDE; 5 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 33 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 1 applicationNo longer listed under review: 1 applicationSupplement delivery: 1 application
Current coverage may be incomplete
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.
Catalogue holders33View records ↓
Under-review filings8View records ↓
This year’s generic filers5View records ↓
NHSA approval numbers24View records ↓
API companies with A status28View records ↓
Chemical-drug catalogue
Loaded records: 33 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 32 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 |
|---|---|---|---|---|---|---|
| Xi Shi Lan (Nan Yang) Pharma Co., Ltd. romanized | Xi Shi Lan (Nan Yang) Pharma Co., Ltd. romanized | 国药准字H20266234 | 2026/10/13 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shanghai Huan Hua Pharmaceutical Co., Ltd. romanized | Shanghai Huan Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20265516 | 2026/08/04 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Henan Jun Shan Bio Technology Co., Ltd. romanized | Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20265252 | 2026/07/21 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing Kang Chuan Ji Pharmaceuticals Technology Co., Ltd. romanized | Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized | 国药准字H20264919 | 2026/06/23 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Dong Guan Song Shan Hu Mei Jian Bio Technology Co., Ltd. romanized | Dong Guan Shi Jin Mei Ji Pharma Co., Ltd. romanized | 国药准字H20264850 | 2026/06/17 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized | Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized | 国药准字H20264351 | 2026/05/19 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangxi Jin Shi Kang Pharma Co., Ltd. romanized | Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20264026 | 2026/04/14 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20263909 | 2026/04/07 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Sheng Tong Yuan Pharmaceutical Group Co., Ltd. romanized | Sichuan Sheng Xu Hui Pharmaceutical Co., Ltd. romanized | 国药准字H20263292 | 2026/02/02 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Bei Lu Pharma Co., Ltd. romanized | Beijing Bei Lu Pharma Co., Ltd. romanized | 国药准字H20256390 | 2025/12/22 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized | Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized | 国药准字H20255794 | 2025/10/28 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20254863 | 2025/07/15 | See source | Not stated by source | CDE |
| Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized | Zhejiang Si Wei Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254619 | 2025/06/24 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized | Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized | 国药准字H20254049 | 2025/04/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jin Hong Pharma Co., Ltd. romanized | Jin Hong Pharma Co., Ltd. romanized | 国药准字H20249739 | 2024/12/17 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Sheng Da Chemical Pharmaceutical Co., Ltd. romanized | Sheng Da Chemical Pharmaceutical Co., Ltd. romanized | 国药准字HC20240009 | 2024/11/15 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | Kunming Long Jin Pharma Co., Ltd. romanized | 国药准字H20249294 | 2024/11/05 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20244673 | 2024/08/20 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Anhui Pioneer Pharmaceutical Co., Ltd | Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20244579 | 2024/07/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Fuzhou Hai Wang Fu Yao Pharmaceutical Co., Ltd. romanized | Fuzhou Hai Wang Fu Yao Pharmaceutical Co., Ltd. romanized | 国药准字H20244332 | 2024/06/28 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing Zhang Ao Pharmaceutical Co., Ltd. romanized | Nanjing Zhang Ao Pharmaceutical Co., Ltd. romanized | 国药准字H20243930 | 2024/06/04 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Ren He Yi Kang Group Co., Ltd. romanized | Hebei Ren He Yi Kang Pharma Co., Ltd. romanized | 国药准字H20243684 | 2024/05/15 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20243695 | 2024/05/15 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. | 国药准字H20234459 | 2023/10/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Bai Ao Pharmaceuticals Technology Co., Ltd. romanized | Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20234444 | 2023/10/27 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shanghai Jin Cheng Su Zhi Pharma Co., Ltd. romanized | Shanxi Tong Da Pharma Co., Ltd. romanized | 国药准字H20234297 | 2023/10/18 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20234296 | 2023/10/18 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jing Shi (Hangzhou) Pharma Co., Ltd. romanized | ZHEJIANG JINGXIN PHARMACEUTICAL CO.，LTD. | 国药准字H20234251 | 2023/09/28 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangxi Shimei Pharmaceutical Co., Ltd | Jiangxi Shimei Pharmaceutical Co., Ltd | 国药准字H20233803 | 2023/06/27 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Zhong Run Pharma Co., Ltd. romanized | Huayi Pharmaceuticals (Anhui) Co., Ltd. | 国药准字H20233669 | 2023/06/07 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Kelun Pharmaceutical Co., Ltd. | Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20223255 | 2022/04/27 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Xin Hua Pharmaceutical (Gao Mi) Co., Ltd. romanized | 国药准字H20255352 | 2025/09/09 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20234567 | 2023/11/28 | See source | Generic approved under the new chemical-drug registration classification | 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.
NHSA drug codes
Loaded records: 24 distinct approval numbers and 24 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Beijing Bei Lu Pharma Co., Ltd. romanized | 国药准字H20256390 | See source | Not stated by source | XG04BEX006A022010100014 | NHSA |
| Jin Hong Pharma Co., Ltd. romanized | 国药准字H20249739 | See source | Not stated by source | XG04BEX006A022010100591 | NHSA |
| Nanjing Zhang Ao Pharmaceutical Co., Ltd. romanized | 国药准字H20243930 | See source | Not stated by source | XG04BEX006A022010101555 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20223255 | See source | Not stated by source | XG04BEX006A022010102180 | NHSA |
| Sichuan Sheng Tong Yuan Pharmaceutical Group Co., Ltd. romanized | 国药准字H20263292 | See source | Not stated by source | XG04BEX006A022010102237 | NHSA |
| Hebei Long Hai Pharma Co., Ltd. romanized | 国药准字H20233877 | See source | Not stated by source | XG04BEX006A022010102766 | NHSA |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H20234459 | See source | Not stated by source | XG04BEX006A022010104021 | NHSA |
| Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized | 国药准字H20234296 | See source | Not stated by source | XG04BEX006A022010104043 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20255352 | See source | Not stated by source | XG04BEX006A022010104187 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20244579 | See source | Not stated by source | XG04BEX006A022010104339 | NHSA |
| Zhejiang Bai Ao Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20234444 | See source | Not stated by source | XG04BEX006A022010104610 | NHSA |
| Jing Shi (Hangzhou) Pharma Co., Ltd. romanized | 国药准字H20234251 | See source | Not stated by source | XG04BEX006A022010104658 | NHSA |
| Jiangxi Shimei Pharmaceutical Co., Ltd | 国药准字H20233803 | See source | Not stated by source | XG04BEX006A022010105356 | NHSA |
| Jiangxi Hui Ren Pharma Co., Ltd. romanized | 国药准字H20244673 | See source | Not stated by source | XG04BEX006A022010110323 | NHSA |
| Upjohn EESV | H20190071 | See source | Not stated by source | XG04BEX006A022010178724 | NHSA |
| Hubei Fu Rui Long Pharma Co., Ltd. romanized | 国药准字H20234567 | See source | Not stated by source | XG04BEX006A022010180086 | NHSA |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H20243684 | See source | Not stated by source | XG04BEX006A022010183033 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022010183034 | NHSA |
| Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized | 国药准字H20254049 | See source | Not stated by source | XG04BEX006A022010183569 | NHSA |
| Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized | 国药准字H20255794 | See source | Not stated by source | XG04BEX006A022010184005 | NHSA |
| Zhejiang Jiu Zhou Biopharmaceuticals Co., Ltd. romanized | 国药准字H20254619 | See source | Not stated by source | XG04BEX006A022010184212 | NHSA |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H20249294 | See source | Not stated by source | XG04BEX006A022010184548 | NHSA |
| Zhong Run Pharma Co., Ltd. romanized | 国药准字H20233669 | See source | Not stated by source | XG04BEX006A022010184795 | NHSA |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20254863 | See source | Not stated by source | XG04BEX006A022010185352 | NHSA |
| Jin Hong Pharma Co., Ltd. romanized | 国药准字H20249739 | See source | Not stated by source | XG04BEX006A022010200591 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20223255 | See source | Not stated by source | XG04BEX006A022010202180 | NHSA |
| Hebei Long Hai Pharma Co., Ltd. romanized | 国药准字H20233877 | See source | Not stated by source | XG04BEX006A022010202766 | NHSA |
| Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized | 国药准字H20234296 | See source | Not stated by source | XG04BEX006A022010204043 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20255352 | See source | Not stated by source | XG04BEX006A022010204187 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20244579 | See source | Not stated by source | XG04BEX006A022010204339 | NHSA |
| Jing Shi (Hangzhou) Pharma Co., Ltd. romanized | 国药准字H20234251 | See source | Not stated by source | XG04BEX006A022010204658 | NHSA |
| Jiangxi Shimei Pharmaceutical Co., Ltd | 国药准字H20233803 | See source | Not stated by source | XG04BEX006A022010205356 | NHSA |
| Jiangxi Hui Ren Pharma Co., Ltd. romanized | 国药准字H20244673 | See source | Not stated by source | XG04BEX006A022010210323 | NHSA |
| Upjohn EESV | H20190071 | See source | Not stated by source | XG04BEX006A022010278724 | NHSA |
| Hubei Fu Rui Long Pharma Co., Ltd. romanized | 国药准字H20234567 | See source | Not stated by source | XG04BEX006A022010280086 | NHSA |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H20243684 | See source | Not stated by source | XG04BEX006A022010283033 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022010283034 | NHSA |
| Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized | 国药准字H20254049 | See source | Not stated by source | XG04BEX006A022010283569 | NHSA |
| Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized | 国药准字H20255794 | See source | Not stated by source | XG04BEX006A022010284005 | NHSA |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H20249294 | See source | Not stated by source | XG04BEX006A022010284548 | NHSA |
| Zhong Run Pharma Co., Ltd. romanized | 国药准字H20233669 | See source | Not stated by source | XG04BEX006A022010284795 | NHSA |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20254863 | See source | Not stated by source | XG04BEX006A022010285352 | NHSA |
| Jin Hong Pharma Co., Ltd. romanized | 国药准字H20249739 | See source | Not stated by source | XG04BEX006A022010300591 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20223255 | See source | Not stated by source | XG04BEX006A022010302180 | NHSA |
| Hebei Long Hai Pharma Co., Ltd. romanized | 国药准字H20233877 | See source | Not stated by source | XG04BEX006A022010302766 | NHSA |
| Qingdao Huang Hai Pharmaceutical Co., Ltd. romanized | 国药准字H20234296 | See source | Not stated by source | XG04BEX006A022010304043 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20244579 | See source | Not stated by source | XG04BEX006A022010304339 | NHSA |
| Jiangxi Shimei Pharmaceutical Co., Ltd | 国药准字H20233803 | See source | Not stated by source | XG04BEX006A022010305356 | NHSA |
| Jiangxi Hui Ren Pharma Co., Ltd. romanized | 国药准字H20244673 | See source | Not stated by source | XG04BEX006A022010310323 | NHSA |
| Upjohn EESV | H20190071 | See source | Not stated by source | XG04BEX006A022010378724 | NHSA |
| Hubei Fu Rui Long Pharma Co., Ltd. romanized | 国药准字H20234567 | See source | Not stated by source | XG04BEX006A022010380086 | NHSA |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H20243684 | See source | Not stated by source | XG04BEX006A022010383033 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022010383034 | NHSA |
| Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized | 国药准字H20254049 | See source | Not stated by source | XG04BEX006A022010383569 | NHSA |
| Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized | 国药准字H20255794 | See source | Not stated by source | XG04BEX006A022010384005 | NHSA |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H20249294 | See source | Not stated by source | XG04BEX006A022010384548 | NHSA |
| Zhong Run Pharma Co., Ltd. romanized | 国药准字H20233669 | See source | Not stated by source | XG04BEX006A022010384795 | NHSA |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20254863 | See source | Not stated by source | XG04BEX006A022010385352 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20223255 | See source | Not stated by source | XG04BEX006A022010402180 | NHSA |
| Hebei Long Hai Pharma Co., Ltd. romanized | 国药准字H20233877 | See source | Not stated by source | XG04BEX006A022010402766 | NHSA |
| Anhui Pioneer Pharmaceutical Co., Ltd | 国药准字H20244579 | See source | Not stated by source | XG04BEX006A022010404339 | NHSA |
| Jiangxi Shimei Pharmaceutical Co., Ltd | 国药准字H20233803 | See source | Not stated by source | XG04BEX006A022010405356 | NHSA |
| Jiangxi Hui Ren Pharma Co., Ltd. romanized | 国药准字H20244673 | See source | Not stated by source | XG04BEX006A022010410323 | NHSA |
| Upjohn EESV | H20190071 | See source | Not stated by source | XG04BEX006A022010478724 | NHSA |
| Hubei Fu Rui Long Pharma Co., Ltd. romanized | 国药准字H20234567 | See source | Not stated by source | XG04BEX006A022010480086 | NHSA |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H20243684 | See source | Not stated by source | XG04BEX006A022010483033 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022010483034 | NHSA |
| Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized | 国药准字H20254049 | See source | Not stated by source | XG04BEX006A022010483569 | NHSA |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H20249294 | See source | Not stated by source | XG04BEX006A022010484548 | NHSA |
| Zhong Run Pharma Co., Ltd. romanized | 国药准字H20233669 | See source | Not stated by source | XG04BEX006A022010484795 | NHSA |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20254863 | See source | Not stated by source | XG04BEX006A022010485352 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20223255 | See source | Not stated by source | XG04BEX006A022010502180 | NHSA |
| Hebei Long Hai Pharma Co., Ltd. romanized | 国药准字H20233877 | See source | Not stated by source | XG04BEX006A022010502766 | NHSA |
| Jiangxi Shimei Pharmaceutical Co., Ltd | 国药准字H20233803 | See source | Not stated by source | XG04BEX006A022010505356 | NHSA |
| Jiangxi Hui Ren Pharma Co., Ltd. romanized | 国药准字H20244673 | See source | Not stated by source | XG04BEX006A022010510323 | NHSA |
| Hubei Fu Rui Long Pharma Co., Ltd. romanized | 国药准字H20234567 | See source | Not stated by source | XG04BEX006A022010580086 | NHSA |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H20243684 | See source | Not stated by source | XG04BEX006A022010583033 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022010583034 | NHSA |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H20249294 | See source | Not stated by source | XG04BEX006A022010584548 | NHSA |
| Zhong Run Pharma Co., Ltd. romanized | 国药准字H20233669 | See source | Not stated by source | XG04BEX006A022010584795 | NHSA |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20254863 | See source | Not stated by source | XG04BEX006A022010585352 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20223255 | See source | Not stated by source | XG04BEX006A022010602180 | NHSA |
| Hebei Long Hai Pharma Co., Ltd. romanized | 国药准字H20233877 | See source | Not stated by source | XG04BEX006A022010602766 | NHSA |
| Jiangxi Shimei Pharmaceutical Co., Ltd | 国药准字H20233803 | See source | Not stated by source | XG04BEX006A022010605356 | NHSA |
| Jiangxi Hui Ren Pharma Co., Ltd. romanized | 国药准字H20244673 | See source | Not stated by source | XG04BEX006A022010610323 | NHSA |
| Hubei Fu Rui Long Pharma Co., Ltd. romanized | 国药准字H20234567 | See source | Not stated by source | XG04BEX006A022010680086 | NHSA |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H20243684 | See source | Not stated by source | XG04BEX006A022010683033 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022010683034 | NHSA |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H20249294 | See source | Not stated by source | XG04BEX006A022010684548 | NHSA |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20254863 | See source | Not stated by source | XG04BEX006A022010685352 | NHSA |
| Hebei Long Hai Pharma Co., Ltd. romanized | 国药准字H20233877 | See source | Not stated by source | XG04BEX006A022010702766 | NHSA |
| Jiangxi Shimei Pharmaceutical Co., Ltd | 国药准字H20233803 | See source | Not stated by source | XG04BEX006A022010705356 | NHSA |
| Jiangxi Hui Ren Pharma Co., Ltd. romanized | 国药准字H20244673 | See source | Not stated by source | XG04BEX006A022010710323 | NHSA |
| Hubei Fu Rui Long Pharma Co., Ltd. romanized | 国药准字H20234567 | See source | Not stated by source | XG04BEX006A022010780086 | NHSA |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H20243684 | See source | Not stated by source | XG04BEX006A022010783033 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022010783034 | NHSA |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H20249294 | See source | Not stated by source | XG04BEX006A022010784548 | NHSA |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20254863 | See source | Not stated by source | XG04BEX006A022010785352 | NHSA |
| Hebei Long Hai Pharma Co., Ltd. romanized | 国药准字H20233877 | See source | Not stated by source | XG04BEX006A022010802766 | NHSA |
| Hubei Fu Rui Long Pharma Co., Ltd. romanized | 国药准字H20234567 | See source | Not stated by source | XG04BEX006A022010880086 | NHSA |
| Ren He Yi Kang Group Co., Ltd. romanized | 国药准字H20243684 | See source | Not stated by source | XG04BEX006A022010883033 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022010883034 | NHSA |
| Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized | 国药准字H20249294 | See source | Not stated by source | XG04BEX006A022010884548 | NHSA |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20254863 | See source | Not stated by source | XG04BEX006A022010885352 | NHSA |
| Hebei Long Hai Pharma Co., Ltd. romanized | 国药准字H20233877 | See source | Not stated by source | XG04BEX006A022010902766 | NHSA |
| Hubei Fu Rui Long Pharma Co., Ltd. romanized | 国药准字H20234567 | See source | Not stated by source | XG04BEX006A022010980086 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022010983034 | NHSA |
| Hebei Long Hai Pharma Co., Ltd. romanized | 国药准字H20233877 | See source | Not stated by source | XG04BEX006A022011002766 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022011083034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022011183034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022011283034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022011383034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022011483034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022011583034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022011683034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022011783034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022011883034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022011983034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022012083034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022012183034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022012283034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022012383034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022012483034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022012583034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022012683034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022012783034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022012883034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022012983034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022013083034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022013183034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022013283034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022013383034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022013483034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022013583034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022013683034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022013783034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022013883034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022013983034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022014083034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022014183034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022014283034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20243695 | See source | Not stated by source | XG04BEX006A022014383034 | NHSA |
| Jin Hong Pharma Co., Ltd. romanized | 国药准字H20249739 | See source | Not stated by source | XG04BEX006A022020100591 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20223255 | See source | Not stated by source | XG04BEX006A022020102180 | NHSA |
| Zhejiang Bai Ao Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20234444 | See source | Not stated by source | XG04BEX006A022020104610 | NHSA |
| Jiangxi Shimei Pharmaceutical Co., Ltd | 国药准字H20233803 | See source | Not stated by source | XG04BEX006A022020105356 | NHSA |
| Hubei Fu Rui Long Pharma Co., Ltd. romanized | 国药准字H20234567 | See source | Not stated by source | XG04BEX006A022020180086 | NHSA |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20254863 | See source | Not stated by source | XG04BEX006A022020185352 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20223255 | See source | Not stated by source | XG04BEX006A022020202180 | NHSA |
| Zhejiang Bai Ao Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20234444 | See source | Not stated by source | XG04BEX006A022020204610 | NHSA |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20254863 | See source | Not stated by source | XG04BEX006A022020285352 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20223255 | See source | Not stated by source | XG04BEX006A022020302180 | NHSA |
| Zhejiang Bai Ao Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20234444 | See source | Not stated by source | XG04BEX006A022020304610 | NHSA |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20254863 | See source | Not stated by source | XG04BEX006A022020385352 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20223255 | See source | Not stated by source | XG04BEX006A022020402180 | NHSA |
| Zhejiang Bai Ao Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20234444 | See source | Not stated by source | XG04BEX006A022020404610 | NHSA |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20254863 | See source | Not stated by source | XG04BEX006A022020485352 | NHSA |
| Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20223255 | See source | Not stated by source | XG04BEX006A022020502180 | NHSA |
| Zhejiang Bai Ao Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20234444 | See source | Not stated by source | XG04BEX006A022020504610 | NHSA |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20254863 | See source | Not stated by source | XG04BEX006A022020585352 | NHSA |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20254863 | See source | Not stated by source | XG04BEX006A022020685352 | NHSA |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20254863 | See source | Not stated by source | XG04BEX006A022020785352 | NHSA |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20254863 | See source | Not stated by source | XG04BEX006A022020885352 | NHSA |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20254863 | See source | Not stated by source | XG04BEX006A022020985352 | NHSA |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20254863 | See source | Not stated by source | XG04BEX006A022021085352 | NHSA |
| Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 国药准字H20254863 | See source | Not stated by source | XG04BEX006A022021185352 | NHSA |
| Hubei Fu Rui Long Pharma Co., Ltd. romanized | 国药准字H20234567 | See source | Not stated by source | XG04BEX006A022030180086 | NHSA |
| Hubei Fu Rui Long Pharma Co., Ltd. romanized | 国药准字H20234567 | See source | Not stated by source | XG04BEX006A022040180086 | 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.
Current under-review applications
Loaded records: 8 filings and 8 distinct first applicants.
Generic 8
New generic filings in 2026
Loaded records: 5 filings and 5 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Hua Tai Min Kang (Shenyang) Technology Co., Ltd. romanized; Suzhou Te Rui Pharma Co., Ltd. romanized | CYHS2600476 | Generic | 2026/02/14 | Not stated by source | CDE |
| Guangzhou Hu Rui Pharmaceuticals Technology Development Co., Ltd. romanized; Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized | CYHS2602376 | Generic | 2026/09/21 | Not stated by source | CDE |
| Hubei Fei Rui Bio Pharma Co., Ltd. romanized | CYHS2601149 | Generic | 2026/05/14 | Not stated by source | CDE |
| Shandong Innovation Drug Research and Development Co., Ltd. romanized; Jiangxi Shimei Pharmaceutical Co., Ltd | CYHS2600883 | Generic | 2026/04/17 | Not stated by source | CDE |
| Hubei Wu Shi Pharma Co., Ltd. romanized | CYHS2600283 | Generic | 2026/01/27 | Not stated by source | CDE |
API registrations
Non-component matches: 28 companies with A status and 9 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 |
|---|---|---|---|---|---|---|
| 枸橼酸西地那非 · No verified English name | Upjohn EESV | Y20260000283 | I | Exact ingredient | 2026/07/16 | CDE |
| 枸橼酸西地那非 · No verified English name | Smilax Laboratories Limited | Y20250000574 | I | Exact ingredient | 2025/09/17 | CDE |
| 枸橼酸西地那非 · No verified English name | Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized | Y20240000285 | A | Exact ingredient | 2025/07/31 | CDE |
| 枸橼酸西地那非 · No verified English name | Haleos Labs Limited, Unit 1 | Y20230000237 | A | Exact ingredient | 2026/05/20 | CDE |
| 枸橼酸西地那非 · No verified English name | SMS Pharmaceuticals Limited | Y20220000208 | A | Exact ingredient | 2026/10/31 | CDE |
| 枸橼酸西地那非 · No verified English name | Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Chemical Pharmaceutical Factory romanized | Y20220000281 | A | Exact ingredient | 2025/02/25 | CDE |
| 枸橼酸西地那非 · No verified English name | Sui Cheng Pharma Co., Ltd. romanized | Y20220000424 | A | Exact ingredient | 2024/12/31 | CDE |
| 枸橼酸西地那非 · No verified English name | Hebei An Jian Cheng Yi Pharmaceuticals Technology Co., Ltd. romanized | Y20220000007 | A | Exact ingredient | 2024/03/19 | CDE |
| 枸橼酸西地那非 · No verified English name | Upjohn EESV | Y20210000693 | I | Exact ingredient | 2024/07/23 | CDE |
| 枸橼酸西地那非 · No verified English name | Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanized | Y20210000463 | A | Exact ingredient | 2023/08/29 | CDE |
| 枸橼酸西地那非 · No verified English name | Raks Pharma Pvt. Ltd. | Y20210000303 | I | Exact ingredient | 2021/07/07 | CDE |
| 枸橼酸西地那非 · No verified English name | Xin Xiang Pharmaceutical Co., Ltd. romanized | Y20210000286 | A | Exact ingredient | 2026/03/10 | CDE |
| 枸橼酸西地那非 · No verified English name | Apitoria Pharma Private Limited | Y20200001254 | A | Exact ingredient | 2026/02/14 | CDE |
| 枸橼酸西地那非 · No verified English name | Di Jia Pharma Group Co., Ltd. romanized | Y20200001215 | A | Exact ingredient | 2026/09/27 | CDE |
| 枸橼酸西地那非 · No verified English name | Azico Biophore India Pvt.Ltd. | Y20200001203 | A | Exact ingredient | 2025/06/15 | CDE |
| 枸橼酸西地那非 · No verified English name | Sichuan Kelun Pharmaceutical Co., Ltd. | Y20190021415 | A | Exact ingredient | 2024/01/26 | CDE |
| 枸橼酸西地那非 · No verified English name | Hetero Drugs Limited | Y20190000581 | A | Exact ingredient | 2025/12/06 | CDE |
| 枸橼酸西地那非 · No verified English name | Pfizer Inc. | Y20190009929 | A | Exact ingredient | 2023/03/24 | CDE |
| 枸橼酸西地那非 · No verified English name | Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Chemical Pharmaceutical Factory romanized | Y20190009908 | A | Exact ingredient | 2024/07/11 | CDE |
| 枸橼酸西地那非 · No verified English name | Hebei Chang Shan Sheng Hua Pharma Co., Ltd. romanized | Y20190009794 | A | Exact ingredient | — | CDE |
| 枸橼酸西地那非 · No verified English name | Changzhou Ya Bang Pharmaceutical Co., Ltd. romanized | Y20190009373 | A | Exact ingredient | 2024/10/23 | CDE |
| 枸橼酸西地那非 · No verified English name | Sichuan Yuan Ji Pharmaceutical Co., Ltd. romanized | Y20190008890 | A | Exact ingredient | 2023/03/24 | CDE |
| 枸橼酸西地那非 · No verified English name | Qilu Pharmaceutical Co., Ltd. | Y20190006703 | A | Exact ingredient | 2026/07/24 | CDE |
| 枸橼酸西地那非 · No verified English name | Changzhou Ya Bang Pharmaceutical Co., Ltd. romanized | Y20180001257 | I | Exact ingredient | 2023/03/24 | CDE |
| 枸橼酸西地那非 · No verified English name | MSN Organics Private Limited | Y20180001023 | A | Exact ingredient | 2026/06/09 | CDE |
| 枸橼酸西地那非 · No verified English name | Hebei Chang Shan Sheng Hua Pharma Co., Ltd. romanized | Y20180001559 | A | Exact ingredient | 2026/05/20 | CDE |
| 枸橼酸西地那非 · No verified English name | Guangzhou Bai Yun Shan Pharmaceuticals Group Co., Ltd. Bai Yun Shan Chemical Pharmaceutical Factory romanized | Y20180001073 | I | Exact ingredient | 2018/09/29 | CDE |
| 枸橼酸西地那非 · No verified English name | Upjohn EESV | Y20170002198 | A | Exact ingredient | 2025/08/01 | CDE |
| 枸橼酸西地那非 · No verified English name | Jilin Jin Heng Pharmaceutical Co., Ltd. romanized | Y20170002066 | A | Exact ingredient | 2025/01/04 | CDE |
| 枸橼酸西地那非 · No verified English name | Upjohn EESV | Y20170001942 | A | Exact ingredient | 2025/08/01 | CDE |
| 枸橼酸西地那非 · No verified English name | Zhejiang Jiu Zhou Drug Technology Co., Ltd. romanized | Y20170001329 | A | Exact ingredient | 2024/09/27 | CDE |
| 枸橼酸西地那非 · No verified English name | Fujian Guang Sheng Tang Pharma Co., Ltd. romanized | Y20170001223 | A | Exact ingredient | 2022/09/30 | CDE |
| 枸橼酸西地那非 · No verified English name | Jinan Ming Xin Pharmaceutical Co., Ltd. romanized | Y20170001189 | A | Exact ingredient | 2024/04/16 | CDE |
| 枸橼酸西地那非 · No verified English name | — | Y20170000881 | I | Exact ingredient | — | CDE |
| 枸橼酸西地那非 · No verified English name | Rui Yang Pharmaceutical Co., Ltd. romanized | Y20170000859 | A | Exact ingredient | 2024/03/01 | CDE |
| 枸橼酸西地那非 · No verified English name | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized | Y20170000777 | A | Exact ingredient | 2024/08/07 | CDE |
| 枸橼酸西地那非 · No verified English name | Le Pu Pharma Co., Ltd. romanized | Y20170000614 | I | Exact ingredient | — | CDE |
| 枸橼酸西地那非 · No verified English name | Pharmaceutical Works Polpharma S.A. | Y20170000462 | A | Exact ingredient | 2025/10/24 | CDE |
| 枸橼酸西地那非 · No verified English name | Assia Chemical Industries Ltd. | Y20170000393 | A | Exact ingredient | 2025/05/29 | CDE |
| 枸橼酸西地那非 · No verified English name | Shandong Luo Xin Pharma Group Co., Ltd. romanized | Y20170000357 | I | Exact ingredient | — | 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.
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.
-
2026/10/23No longer listed under review
Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized; Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized
CYHB2601448
Fact date: 2026/10/23 · Site observation date: 2026/10/23
Accepted: 2026/07/28
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); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 18
NMPA · Table row 18 ↗ View source ↗ -
2026/10/21Supplement delivery
Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized
CYHB2601448
Fact date: 2026/10/21 · Publication date: 2026/10/23 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 18 ↗ -
2026/09/21Accepted
Guangzhou Hu Rui Pharmaceuticals Technology Development Co., Ltd. romanized; Zhuhai Run Dou Pharmaceutical Co., Ltd. romanized
CYHS2602376
Fact date: 2026/09/21 · 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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