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Public drug landscapesDrug landscape

Ezetimibe Tablets

As of 13 November 2026, for Ezetimibe Tablets, 4 applications are listed as under review at China's CDE; 3 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 21 holders.

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

Listed in the US FDA Orange Book as ZETIA (NDA 021445, ORGANON LLC A SUB OF ORGANON AND CO).

Last 90 days: Accepted: 2 applications

Current coverage may be incomplete

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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
ZETIA ORGANON LLC A SUB OF ORGANON AND CO NDA 021445 · Product no. 001 TABLET ORAL HUMAN PRESCRIPTION DRUG 2002/10/25

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: 21 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 19 in the new chemical-registration-classification generic category. Category counts may overlap.

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanizedHunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized国药准字H202655642026/08/0410mgGeneric approved under the new chemical-drug registration classificationCDE
Beijing Ya Bao Bio Pharma Co., Ltd. romanizedBeijing Ya Bao Bio Pharma Co., Ltd. romanized国药准字H202643962026/05/1910mgGeneric approved under the new chemical-drug registration classificationCDE
Hua Run Sai Ke Pharma Co., Ltd. romanizedHua Run Sai Ke Pharma Co., Ltd. romanized国药准字H202642372026/05/0710mgGeneric approved under the new chemical-drug registration classificationCDE
Hetero Labs LimitedHetero Labs Limited国药准字HJ202600342026/04/1410mgGeneric approved under the new chemical-drug registration classificationCDE
Jiangxi Shimei Pharmaceutical Co., LtdJiangxi Shimei Pharmaceutical Co., Ltd国药准字H202634592026/02/2510mgGeneric approved under the new chemical-drug registration classificationCDE
Ling Yao Bio Technology (Shanghai) Co., Ltd. romanizedJiangsu Fu Dan Fu Hua Pharma Co., Ltd. romanized国药准字H202561392025/12/0310mgGeneric approved under the new chemical-drug registration classificationCDE
Shandong Lukang Pharmaceutical Co.,Ltd.Shandong Lukang Pharmaceutical Co.,Ltd.国药准字H202531622025/01/1410mgGeneric approved under the new chemical-drug registration classificationCDE
Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanizedKunming Long Jin Pharma Co., Ltd. romanized国药准字H202498182024/12/2510mgNot stated by sourceCDE
Shandong Xin Shi Dai Pharma Co., Ltd. romanizedShandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H202497372024/12/1710mgGeneric approved under the new chemical-drug registration classificationCDE
Jiangsu Deyuan Pharmaceutical Co.,Ltd.Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H202494982024/12/0110mgGeneric approved under the new chemical-drug registration classificationCDE
Beijing Bai Ao Pharma Co., Ltd. romanizedWuxi Fu Qi Pharmaceutical Co., Ltd. romanized国药准字H202491712024/10/2210mgGeneric approved under the new chemical-drug registration classificationCDE
Changzhou Pharmaceutical Factory Co., Ltd. romanizedChangzhou Pharmaceutical Factory Co., Ltd. romanized国药准字H202440672024/06/1810mgGeneric approved under the new chemical-drug registration classificationCDE
Shandong Dan Hong Pharmaceutical Co., Ltd. romanizedShandong Bu Zhang Pharmaceutical Co., Ltd. romanized国药准字H202437622024/05/2110mgGeneric approved under the new chemical-drug registration classificationCDE
Zhejiang Nord Pharmaceutical Co., LtdZhejiang Nord Pharmaceutical Co., Ltd国药准字H202432532024/02/2310mgGeneric approved under the new chemical-drug registration classificationCDE
Nanjing Hai Jing Pharma Co., Ltd. romanizedHangzhou Minsheng Pharmaceutical Co., Ltd国药准字H202331642023/02/1410mgGeneric approved under the new chemical-drug registration classificationCDE
Suzhou Hua Jian Rui Da Pharmaceuticals Technology Co., Ltd. romanizedJiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized国药准字H202137602021/09/3010mgGeneric approved under the new chemical-drug registration classificationCDE
Beijing Foyou Pharma CO.,LTDBeijing Foyou Pharma CO.,LTD国药准字H202135842021/07/2010mgGeneric approved under the new chemical-drug registration classificationCDE
Chongqing Sheng Hua Xi Pharma Co., Ltd. romanizedChongqing Sheng Hua Xi Pharma Co., Ltd. romanized国药准字H202135852021/07/2010mgGeneric approved under the new chemical-drug registration classificationCDE
Sandoz Inc.Lek Pharmaceuticals d. d.国药准字HJ202100502021/06/2910mgGeneric approved under the new chemical-drug registration classificationCDE
Hunan Fang Sheng Pharmaceutical Co., Ltd. romanizedHunan Fang Sheng Pharmaceutical Co., Ltd. romanized国药准字H202034682020/09/0810mgGeneric approved under the new chemical-drug registration classificationCDE
MSD Pharma (Singapore) Pte. Ltd.MSD International GmbH (Singapore Branch)H201601812006/04/0610mgImported 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: 23 distinct approval numbers and 23 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Hua Run Sai Ke Pharma Co., Ltd. romanized国药准字H2026423710mgCategory BXC10AXY097A001010100111NHSA
Beijing Foyou Pharma CO.,LTD国药准字H2021358410mgCategory BXC10AXY097A001010100177NHSA
Changzhou Pharmaceutical Factory Co., Ltd. romanized国药准字H2024406710mgCategory BXC10AXY097A001010101397NHSA
Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized国药准字H2021376010mgCategory BXC10AXY097A001010101504NHSA
Shandong Xin Lu Pharmaceuticals Technology Co., Ltd. romanized国药准字H2023316410mgCategory BXC10AXY097A001010101564NHSA
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H2024973710mgCategory BXC10AXY097A001010104188NHSA
MSD Pharma(Singapore) Pte. Ltd.国药准字J2017102310mgCategory BXC10AXY097A001010104495NHSA
Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized国药准字H2020346810mgCategory BXC10AXY097A001010104920NHSA
Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized国药准字H2026556410mgCategory BXC10AXY097A001010104960NHSA
Jiangxi Shimei Pharmaceutical Co., Ltd国药准字H2026345910mgCategory BXC10AXY097A001010105356NHSA
Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H2024949810mgCategory BXC10AXY097A001010106632NHSA
Beijing Ya Bao Bio Pharma Co., Ltd. romanized国药准字H2026439610mgCategory BXC10AXY097A001010109542NHSA
Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized国药准字H2021358510mgCategory BXC10AXY097A001010109568NHSA
MSD International GmbH (Singapore Branch)H2016018110mgCategory BXC10AXY097A001010178893NHSA
Hetero Labs Limited国药准字HJ2026003410mgCategory BXC10AXY097A001010179426NHSA
Shandong Dan Hong Pharmaceutical Co., Ltd. romanized国药准字H2024376210mgCategory BXC10AXY097A001010180472NHSA
Beijing Bai Ao Pharma Co., Ltd. romanized国药准字H2024917110mgCategory BXC10AXY097A001010183058NHSA
Shandong Lukang Pharmaceutical Co.,Ltd.国药准字H2025316210mgCategory BXC10AXY097A001010183198NHSA
Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized国药准字H2025613910mgCategory BXC10AXY097A001010183356NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001010183521NHSA
Sandoz Inc.国药准字HJ2021005010mgCategory BXC10AXY097A001010183662NHSA
Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized国药准字H2024981810mgCategory BXC10AXY097A001010184548NHSA
Hua Run Sai Ke Pharma Co., Ltd. romanized国药准字H2026423710mgCategory BXC10AXY097A001010200111NHSA
Beijing Foyou Pharma CO.,LTD国药准字H2021358410mgCategory BXC10AXY097A001010200177NHSA
Changzhou Pharmaceutical Factory Co., Ltd. romanized国药准字H2024406710mgCategory BXC10AXY097A001010201397NHSA
Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized国药准字H2021376010mgCategory BXC10AXY097A001010201504NHSA
Shandong Xin Lu Pharmaceuticals Technology Co., Ltd. romanized国药准字H2023316410mgCategory BXC10AXY097A001010201564NHSA
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H2024973710mgCategory BXC10AXY097A001010204188NHSA
MSD Pharma(Singapore) Pte. Ltd.国药准字J2017102310mgCategory BXC10AXY097A001010204495NHSA
Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized国药准字H2020346810mgCategory BXC10AXY097A001010204920NHSA
Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H2024949810mgCategory BXC10AXY097A001010206632NHSA
Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized国药准字H2021358510mgCategory BXC10AXY097A001010209568NHSA
MSD International GmbH (Singapore Branch)H2016018110mgCategory BXC10AXY097A001010278893NHSA
Hetero Labs Limited国药准字HJ2026003410mgCategory BXC10AXY097A001010279426NHSA
Beijing Bai Ao Pharma Co., Ltd. romanized国药准字H2024917110mgCategory BXC10AXY097A001010283058NHSA
Shandong Lukang Pharmaceutical Co.,Ltd.国药准字H2025316210mgCategory BXC10AXY097A001010283198NHSA
Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized国药准字H2025613910mgCategory BXC10AXY097A001010283356NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001010283521NHSA
Sandoz Inc.国药准字HJ2021005010mgCategory BXC10AXY097A001010283662NHSA
Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized国药准字H2024981810mgCategory BXC10AXY097A001010284548NHSA
Hua Run Sai Ke Pharma Co., Ltd. romanized国药准字H2026423710mgCategory BXC10AXY097A001010300111NHSA
Beijing Foyou Pharma CO.,LTD国药准字H2021358410mgCategory BXC10AXY097A001010300177NHSA
Changzhou Pharmaceutical Factory Co., Ltd. romanized国药准字H2024406710mgCategory BXC10AXY097A001010301397NHSA
Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized国药准字H2021376010mgCategory BXC10AXY097A001010301504NHSA
Shandong Xin Lu Pharmaceuticals Technology Co., Ltd. romanized国药准字H2023316410mgCategory BXC10AXY097A001010301564NHSA
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H2024973710mgCategory BXC10AXY097A001010304188NHSA
MSD Pharma(Singapore) Pte. Ltd.国药准字J2017102310mgCategory BXC10AXY097A001010304495NHSA
Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized国药准字H2020346810mgCategory BXC10AXY097A001010304920NHSA
Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H2024949810mgCategory BXC10AXY097A001010306632NHSA
Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized国药准字H2021358510mgCategory BXC10AXY097A001010309568NHSA
ORGANON SINGAPORE PTE. LTD.国药准字HJ2016018110mgCategory BXC10AXY097A001010378893NHSA
Beijing Bai Ao Pharma Co., Ltd. romanized国药准字H2024917110mgCategory BXC10AXY097A001010383058NHSA
Shandong Lukang Pharmaceutical Co.,Ltd.国药准字H2025316210mgCategory BXC10AXY097A001010383198NHSA
Ling Yao Bio Technology (Shanghai) Co., Ltd. romanized国药准字H2025613910mgCategory BXC10AXY097A001010383356NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001010383521NHSA
Sandoz Inc.国药准字HJ2021005010mgCategory BXC10AXY097A001010383662NHSA
Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized国药准字H2024981810mgCategory BXC10AXY097A001010384548NHSA
Beijing Foyou Pharma CO.,LTD国药准字H2021358410mgCategory BXC10AXY097A001010400177NHSA
Changzhou Pharmaceutical Factory Co., Ltd. romanized国药准字H2024406710mgCategory BXC10AXY097A001010401397NHSA
Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized国药准字H2021376010mgCategory BXC10AXY097A001010401504NHSA
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H2024973710mgCategory BXC10AXY097A001010404188NHSA
Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized国药准字H2020346810mgCategory BXC10AXY097A001010404920NHSA
Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H2024949810mgCategory BXC10AXY097A001010406632NHSA
Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized国药准字H2021358510mgCategory BXC10AXY097A001010409568NHSA
Shandong Lukang Pharmaceutical Co.,Ltd.国药准字H2025316210mgCategory BXC10AXY097A001010483198NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001010483521NHSA
Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized国药准字H2024981810mgCategory BXC10AXY097A001010484548NHSA
Beijing Foyou Pharma CO.,LTD国药准字H2021358410mgCategory BXC10AXY097A001010500177NHSA
Changzhou Pharmaceutical Factory Co., Ltd. romanized国药准字H2024406710mgCategory BXC10AXY097A001010501397NHSA
Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized国药准字H2021376010mgCategory BXC10AXY097A001010501504NHSA
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H2024973710mgCategory BXC10AXY097A001010504188NHSA
Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized国药准字H2020346810mgCategory BXC10AXY097A001010504920NHSA
Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H2024949810mgCategory BXC10AXY097A001010506632NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001010583521NHSA
Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized国药准字H2024981810mgCategory BXC10AXY097A001010584548NHSA
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H2024973710mgCategory BXC10AXY097A001010604188NHSA
Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized国药准字H2020346810mgCategory BXC10AXY097A001010604920NHSA
Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H2024949810mgCategory BXC10AXY097A001010606632NHSA
ORGANON SINGAPORE PTE. LTD.国药准字HJ2016018110mgCategory BXC10AXY097A001010678893NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001010683521NHSA
Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized国药准字H2024981810mgCategory BXC10AXY097A001010684548NHSA
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H2024973710mgCategory BXC10AXY097A001010704188NHSA
Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized国药准字H2020346810mgCategory BXC10AXY097A001010704920NHSA
Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H2024949810mgCategory BXC10AXY097A001010706632NHSA
ORGANON SINGAPORE PTE. LTD.国药准字HJ2016018110mgCategory BXC10AXY097A001010778893NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001010783521NHSA
Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized国药准字H2024981810mgCategory BXC10AXY097A001010784548NHSA
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H2024973710mgCategory BXC10AXY097A001010804188NHSA
Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized国药准字H2020346810mgCategory BXC10AXY097A001010804920NHSA
Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H2024949810mgCategory BXC10AXY097A001010806632NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001010883521NHSA
Yunnan Long Jin Kang You Biopharmaceuticals Co., Ltd. romanized国药准字H2024981810mgCategory BXC10AXY097A001010884548NHSA
Shandong Xin Shi Dai Pharma Co., Ltd. romanized国药准字H2024973710mgCategory BXC10AXY097A001010904188NHSA
Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized国药准字H2020346810mgCategory BXC10AXY097A001010904920NHSA
Jiangsu Deyuan Pharmaceutical Co.,Ltd.国药准字H2024949810mgCategory BXC10AXY097A001010906632NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001010983521NHSA
Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized国药准字H2020346810mgCategory BXC10AXY097A001011004920NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001011083521NHSA
Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized国药准字H2020346810mgCategory BXC10AXY097A001011104920NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001011183521NHSA
Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized国药准字H2020346810mgCategory BXC10AXY097A001011204920NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001011283521NHSA
Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized国药准字H2020346810mgCategory BXC10AXY097A001011304920NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001011383521NHSA
Hunan Fang Sheng Pharmaceutical Co., Ltd. romanized国药准字H2020346810mgCategory BXC10AXY097A001011404920NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001011483521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001011583521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001011683521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001011783521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001011883521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001011983521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001012083521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001012183521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001012283521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001012383521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001012483521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001012583521NHSA
Zhejiang Nord Pharmaceutical Co., Ltd国药准字H2024325310mgCategory BXC10AXY097A001012683521NHSA

Approval numbers and companies are deduplicated separately; packaging records remain individually listed. An empty insurance class means it is unstated. NHSA codes supply no approval date and do not establish the outcome of an acceptance number.

Current under-review applications

Loaded records: 4 filings and 4 distinct first applicants.

Generic 4

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Nanjing Hai Jing Pharma Co., Ltd. romanizedCYHS2601395Generic2026/06/12Not stated by sourceCDE
Zhejiang Jiang Bei Pharma Co., Ltd. romanizedCYHS2602544Generic2026/10/14Not stated by sourceCDE
Hainan Sai Li Ke Pharma Co., Ltd. romanizedCYHS2504117Generic2025/12/02Not stated by sourceCDE
Guo Yao Group Zhi Jun (Shenzhen) Pharmaceutical Co., Ltd. romanized; Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanizedCYHS2602594Generic2026/10/22Not stated by sourceCDE
New generic filings in 2026

Loaded records: 3 filings and 3 distinct first applicants.

New generic filings in 2026
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Nanjing Hai Jing Pharma Co., Ltd. romanizedCYHS2601395Generic2026/06/12Not stated by sourceCDE
Zhejiang Jiang Bei Pharma Co., Ltd. romanizedCYHS2602544Generic2026/10/14Not stated by sourceCDE
Guo Yao Group Zhi Jun (Shenzhen) Pharmaceutical Co., Ltd. romanized; Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanizedCYHS2602594Generic2026/10/22Not stated by sourceCDE
API registrations

Non-component matches: 20 companies with A status and 6 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
依折麦布 · No verified English nameJiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanizedY20260000100IExact ingredient2026/02/11CDE
依折麦布 · No verified English nameZhejiang Tian Yu Pharma Co., Ltd. romanizedY20250000915IExact ingredient2025/10/30CDE
依折麦布 · No verified English nameYun Peng Pharmaceuticals Group Co., Ltd. romanizedY20250000047AExact ingredient2026/07/20CDE
依折麦布 · No verified English nameTopfond Pharmaceutical Co., Ltd.Y20240001567AExact ingredient2026/07/14CDE
依折麦布 · No verified English nameSaptagir Laboratories Pvt. Ltd.Y20240000581IExact ingredient2026/04/03CDE
依折麦布 · No verified English nameZhejiang Jing Sheng Pharma Co., Ltd. romanizedY20230001252AExact ingredient2025/07/11CDE
依折麦布 · No verified English nameJiangsu Deyuan Pharmaceutical Co.,Ltd.Y20230000515AExact ingredient2024/09/02CDE
依折麦布 · No verified English nameApitoria Pharma Private LimitedY20230000079AExact ingredient2025/01/06CDE
依折麦布 · No verified English nameHetero Labs LimitedY20220000766AExact ingredient2026/03/19CDE
依折麦布 · No verified English nameYa Bao Pharma Group Co., Ltd. romanizedY20220000666AExact ingredient2026/02/10CDE
依折麦布 · No verified English nameNan Tong Chang You Pharma Technology Co., Ltd. romanizedY20210000966AExact ingredient2023/08/29CDE
依折麦布 · No verified English nameHanmi Fine Chemical Co., Ltd.Y20200001433AExact ingredient2024/10/24CDE
依折麦布 · No verified English nameShandong Xin Shi Dai Pharma Co., Ltd. romanizedY20210000182AExact ingredient2022/11/02CDE
依折麦布 · No verified English nameNanjing You Ke Pharmaceutical Co., Ltd. romanizedY20210000199AExact ingredient2023/02/21CDE
依折麦布 · No verified English nameLUPIN LIMITEDY20210000140AExact ingredient2025/05/17CDE
依折麦布 · No verified English nameShandong Bo Yuan Pharma Co., Ltd. romanizedY20200001270AExact ingredient2024/02/27CDE
依折麦布 · No verified English nameSynthimed Labs Private LimitedY20200001218AExact ingredient2026/07/17CDE
依折麦布 · No verified English nameNeuland Laboratories LtdY20200000801IExact ingredient2020/12/22CDE
依折麦布 · No verified English nameWuxi Fu Qi Pharmaceutical Co., Ltd. romanizedY20200000290AExact ingredient2022/10/27CDE
依折麦布 · No verified English nameZhejiang Tian Yu Pharma Co., Ltd. romanizedY20190000721AExact ingredient2026/01/06CDE
依折麦布 · No verified English nameChongqing Sheng Hua Xi Pharma Co., Ltd. romanizedY20190000874AExact ingredient2026/04/30CDE
依折麦布 · No verified English nameTEVA API INDIA PRIVATE LIMITEDY20190000329AExact ingredient2026/07/15CDE
依折麦布 · No verified English nameAurobindo Pharma LimitedY20180001595IExact ingredient2019/03/20CDE
依折麦布 · No verified English nameHunan Fang Sheng Pharmaceutical Co., Ltd. romanizedY20190000024AExact ingredient2025/09/16CDE
依折麦布 · No verified English nameMSN Laboratories Private Limited Yi De Pharma (Shanghai) Co., Ltd. romanizedY20180001083AExact ingredient2025/07/30CDE
依折麦布 · No verified English nameShandong Lang Nuo Pharmaceutical Co., Ltd. romanizedY20180001036IExact ingredient2018/08/30CDE

A/I are source statuses. Matching uses exact ingredients, salt-normalized names and maintained combination components, without fuzzy matching. A-status companies are deduplicated by the first registered company. Components are excluded from headline counts; the register does not identify the associated formulation.

What changed recently?

Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately.

Trial registration does not mean an application will follow.

This product is outside the trial-registration backfill scope. New registrations after daily collection started remain in scope. Historical rows may also be found by another product search; neither implies complete historical coverage for this product.

NHSA edition maintained to 2026-10-23; latest successful catalogue check: 2026/11/13 06:39. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.

This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.

  1. 2026/10/22Accepted
  2. 2026/10/14Accepted

    Zhejiang Jiang Bei Pharma Co., Ltd. romanized

    CYHS2602544

    Fact date: 2026/10/14 · 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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