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Public drug landscapesDrug landscape

Lidocaine and Prilocaine Cream

As of 13 November 2026, for Lidocaine and Prilocaine Cream, 24 applications are listed as under review at China's CDE; 3 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 0 holders.

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

Last 90 days: Accepted: 9 applicationsNo longer listed under review: 1 application

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 2 of 2 distinct brand names.

A brand with different source forms or statuses can appear on multiple rows and in both groups. Distinct brand names are counted once globally, with a limit of five.

Verified official English dosage form: Cream. 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

No listings in this group among the displayed brand names.

Other dosage forms of the same ingredient

Brand nameApplicant (source text)Application numberDosage form (source text)Route (source text)Marketing status (source text)Approval date
ORAQIX DENTSPLY PHARMACEUTICAL INC NDA 021451 · Product no. 001 GEL PERIODONTAL HUMAN PRESCRIPTION DRUG 2003/12/19
EMLA TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC NDA 019941 · Product no. 001 CREAM TOPICAL DISCONTINUED 1992/12/30
EMLA ASTRAZENECA LP NDA 020962 · Product no. 001 DISC TOPICAL DISCONTINUED 1998/02/04

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

Marketing authorization holderManufacturerApproval numberApprovedStrength / specificationCatalogue category (source text)View source
No matching records were found in the currently loaded source data; coverage dates are listed below.

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: 41 distinct approval numbers and 35 companies.

Company / applicantApproval numberStrength / specificationNHSA classNHSA drug codeView source
Guo Yao Group Zhi Jun (Shenzhen) Ping Shan Pharmaceutical Co., Ltd. romanized国药准字H20254428See sourceNot stated by sourceXN01BBL053F002010100430NHSA
Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized国药准字H20265664See sourceNot stated by sourceXN01BBL053F002010101504NHSA
Suzhou Erye Pharmaceutical Co., Ltd国药准字H20253227See sourceNot stated by sourceXN01BBL053F002010101651NHSA
De Quan Medicines (Jiangsu) Co., Ltd. romanized国药准字H20253274See sourceNot stated by sourceXN01BBL053F002010101751NHSA
Hebei Xin Zhang Yao Co., Ltd. romanized国药准字H20249681See sourceNot stated by sourceXN01BBL053F002010102673NHSA
Guangdong Ke Hong Pharma Co., Ltd. romanized国药准字H20253151See sourceNot stated by sourceXN01BBL053F002010103063NHSA
Shandong Ming Ren Fu Rui Da Pharmaceutical Co., Ltd. romanized国药准字H20253865See sourceNot stated by sourceXN01BBL053F002010104144NHSA
SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED国药准字H20255987See sourceNot stated by sourceXN01BBL053F002010104187NHSA
Zhejiang AngLiKang Pharmaceutical CO.,LTD.国药准字H20253006See sourceNot stated by sourceXN01BBL053F002010104606NHSA
Hunan Jiudian Pharmaceutical Co., Ltd国药准字H20249104See sourceNot stated by sourceXN01BBL053F002010104942NHSA
Jiangxi Shimei Pharmaceutical Co., Ltd国药准字H20253044See sourceNot stated by sourceXN01BBL053F002010105356NHSA
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized国药准字H20249736See sourceNot stated by sourceXN01BBL053F002010105775NHSA
Hunan Zhuang Yuan Pharmaceutical Co., Ltd. romanized国药准字H20254771See sourceNot stated by sourceXN01BBL053F002010105788NHSA
Shanghai Zhao Hui Pharma Co., Ltd. romanized国药准字H20255207See sourceNot stated by sourceXN01BBL053F002010106917NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20253362See sourceNot stated by sourceXN01BBL053F002010107360NHSA
Beijing Zhong Tai Bang Pharmaceuticals Technology Co., Ltd. romanized国药准字H20254628See sourceNot stated by sourceXN01BBL053F002010110137NHSA
Aspen Pharmacare Australia Pty LtdH20100154See sourceNot stated by sourceXN01BBL053F002010179096NHSA
Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized国药准字H20233544See sourceNot stated by sourceXN01BBL053F002010179282NHSA
Fu Yuan Pharma Co., Ltd. romanized国药准字H20254749See sourceNot stated by sourceXN01BBL053F002010180651NHSA
Hubei Cheng Tian Pharma Co., Ltd. romanized国药准字H20255211See sourceNot stated by sourceXN01BBL053F002010180999NHSA
Hua Run Shuang He Pharma Co., Ltd. romanized国药准字H20255085See sourceNot stated by sourceXN01BBL053F002010181661NHSA
Zhejiang Pu Li Pharma Co., Ltd. romanized国药准字H20265498See sourceNot stated by sourceXN01BBL053F002010182922NHSA
Jilin Sheng Jin Pai Ge Pharma Co., Ltd. romanized国药准字H20233629See sourceNot stated by sourceXN01BBL053F002010183354NHSA
Nanjing Rui Jie Pharmaceuticals Technology Co., Ltd. romanized国药准字H20265342See sourceNot stated by sourceXN01BBL053F002010183421NHSA
Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized国药准字H20264611See sourceNot stated by sourceXN01BBL053F002010183595NHSA
Jing Shi (Hangzhou) Pharma Co., Ltd. romanized国药准字H20253898See sourceNot stated by sourceXN01BBL053F002010183975NHSA
Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized国药准字H20249685See sourceNot stated by sourceXN01BBL053F002010184112NHSA
Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized国药准字H20253877See sourceNot stated by sourceXN01BBL053F002010184221NHSA
Ningbo Mei Shu Pharma Co., Ltd. romanized国药准字H20256240See sourceNot stated by sourceXN01BBL053F002010184223NHSA
Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized国药准字H20253758See sourceNot stated by sourceXN01BBL053F002010184235NHSA
Zhejiang Huan Ling Pharmaceuticals Technology Co., Ltd. romanized国药准字H20263664See sourceNot stated by sourceXN01BBL053F002010184239NHSA
Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized国药准字H20253517See sourceNot stated by sourceXN01BBL053F002010184759NHSA
Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized国药准字H20249680See sourceNot stated by sourceXN01BBL053F002010184874NHSA
Hainan He Rui Da Pharma Co., Ltd. romanized国药准字H20249103See sourceNot stated by sourceXN01BBL053F002010185053NHSA
Name not romanized国药准字H20249822See sourceNot stated by sourceXN01BBL053F002010185219NHSA
Hebei Xin Zhang Yao Co., Ltd. romanized国药准字H20249681See sourceNot stated by sourceXN01BBL053F002010202673NHSA
Zhejiang AngLiKang Pharmaceutical CO.,LTD.国药准字H20253006See sourceNot stated by sourceXN01BBL053F002010204606NHSA
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized国药准字H20249736See sourceNot stated by sourceXN01BBL053F002010205775NHSA
Shanghai Zhao Hui Pharma Co., Ltd. romanized国药准字H20255207See sourceNot stated by sourceXN01BBL053F002010206917NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20253362See sourceNot stated by sourceXN01BBL053F002010207360NHSA
Fu Yuan Pharma Co., Ltd. romanized国药准字H20254749See sourceNot stated by sourceXN01BBL053F002010280651NHSA
Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized国药准字H20253877See sourceNot stated by sourceXN01BBL053F002010284221NHSA
Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized国药准字H20253758See sourceNot stated by sourceXN01BBL053F002010284235NHSA
Zhejiang Huan Ling Pharmaceuticals Technology Co., Ltd. romanized国药准字H20263664See sourceNot stated by sourceXN01BBL053F002010284239NHSA
Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized国药准字H20249680See sourceNot stated by sourceXN01BBL053F002010284874NHSA
Zhejiang AngLiKang Pharmaceutical CO.,LTD.国药准字H20253006See sourceNot stated by sourceXN01BBL053F002010304606NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20253362See sourceNot stated by sourceXN01BBL053F002010307360NHSA
Fu Yuan Pharma Co., Ltd. romanized国药准字H20254749See sourceNot stated by sourceXN01BBL053F002010380651NHSA
Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized国药准字H20253877See sourceNot stated by sourceXN01BBL053F002010384221NHSA
Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized国药准字H20253758See sourceNot stated by sourceXN01BBL053F002010384235NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20253362See sourceNot stated by sourceXN01BBL053F002010407360NHSA
Fu Yuan Pharma Co., Ltd. romanized国药准字H20254749See sourceNot stated by sourceXN01BBL053F002010480651NHSA
Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized国药准字H20253877See sourceNot stated by sourceXN01BBL053F002010484221NHSA
Zhejiang Feng Hua Pharmaceuticals Technology Co., Ltd. romanized国药准字H20253758See sourceNot stated by sourceXN01BBL053F002010484235NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20253362See sourceNot stated by sourceXN01BBL053F002010507360NHSA
Fu Yuan Pharma Co., Ltd. romanized国药准字H20254749See sourceNot stated by sourceXN01BBL053F002010580651NHSA
Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized国药准字H20253877See sourceNot stated by sourceXN01BBL053F002010584221NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20253362See sourceNot stated by sourceXN01BBL053F002010607360NHSA
Fu Yuan Pharma Co., Ltd. romanized国药准字H20254749See sourceNot stated by sourceXN01BBL053F002010680651NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20253362See sourceNot stated by sourceXN01BBL053F002010707360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20253362See sourceNot stated by sourceXN01BBL053F002010807360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20253362See sourceNot stated by sourceXN01BBL053F002010907360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20253362See sourceNot stated by sourceXN01BBL053F002011007360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20253362See sourceNot stated by sourceXN01BBL053F002011107360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20253362See sourceNot stated by sourceXN01BBL053F002011207360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20253362See sourceNot stated by sourceXN01BBL053F002011307360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20253362See sourceNot stated by sourceXN01BBL053F002011407360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20253362See sourceNot stated by sourceXN01BBL053F002011507360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20253362See sourceNot stated by sourceXN01BBL053F002011607360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20253362See sourceNot stated by sourceXN01BBL053F002011707360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20253362See sourceNot stated by sourceXN01BBL053F002011807360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20253362See sourceNot stated by sourceXN01BBL053F002011907360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20253362See sourceNot stated by sourceXN01BBL053F002012007360NHSA
Hebei Xin Zhang Yao Co., Ltd. romanized国药准字H20269044See sourceNot stated by sourceXN01BBL053F002020102673NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269015See sourceNot stated by sourceXN01BBL053F002020107360NHSA
Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized国药准字H20233544See sourceNot stated by sourceXN01BBL053F002020179282NHSA
Jilin Sheng Jin Pai Ge Pharma Co., Ltd. romanized国药准字H20233629See sourceNot stated by sourceXN01BBL053F002020183354NHSA
Jing Shi (Hangzhou) Pharma Co., Ltd. romanized国药准字H20258294See sourceNot stated by sourceXN01BBL053F002020183975NHSA
Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized国药准字H20269191See sourceNot stated by sourceXN01BBL053F002020184759NHSA
Hainan He Rui Da Pharma Co., Ltd. romanized国药准字H20249103See sourceNot stated by sourceXN01BBL053F002020185053NHSA
Name not romanized国药准字H20269008See sourceNot stated by sourceXN01BBL053F002020185219NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269015See sourceNot stated by sourceXN01BBL053F002020207360NHSA
Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized国药准字H20269191See sourceNot stated by sourceXN01BBL053F002020284759NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269015See sourceNot stated by sourceXN01BBL053F002020307360NHSA
Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized国药准字H20269191See sourceNot stated by sourceXN01BBL053F002020384759NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269015See sourceNot stated by sourceXN01BBL053F002020407360NHSA
Chengdu Tian Zhi Yi Shang Pin Pharmaceuticals Technology Co., Ltd. romanized国药准字H20269191See sourceNot stated by sourceXN01BBL053F002020484759NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269015See sourceNot stated by sourceXN01BBL053F002020507360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269015See sourceNot stated by sourceXN01BBL053F002020607360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269015See sourceNot stated by sourceXN01BBL053F002020707360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269015See sourceNot stated by sourceXN01BBL053F002020807360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269015See sourceNot stated by sourceXN01BBL053F002020907360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269015See sourceNot stated by sourceXN01BBL053F002021007360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269015See sourceNot stated by sourceXN01BBL053F002021107360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269015See sourceNot stated by sourceXN01BBL053F002021207360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269015See sourceNot stated by sourceXN01BBL053F002021307360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269015See sourceNot stated by sourceXN01BBL053F002021407360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269015See sourceNot stated by sourceXN01BBL053F002021507360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269015See sourceNot stated by sourceXN01BBL053F002021607360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269015See sourceNot stated by sourceXN01BBL053F002021707360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269015See sourceNot stated by sourceXN01BBL053F002021807360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269015See sourceNot stated by sourceXN01BBL053F002021907360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269015See sourceNot stated by sourceXN01BBL053F002022007360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269016See sourceNot stated by sourceXN01BBL053F002030107360NHSA
Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized国药准字H20233544See sourceNot stated by sourceXN01BBL053F002030179282NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269016See sourceNot stated by sourceXN01BBL053F002030207360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269016See sourceNot stated by sourceXN01BBL053F002030307360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269016See sourceNot stated by sourceXN01BBL053F002030407360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269016See sourceNot stated by sourceXN01BBL053F002030507360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269016See sourceNot stated by sourceXN01BBL053F002030607360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269016See sourceNot stated by sourceXN01BBL053F002030707360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269016See sourceNot stated by sourceXN01BBL053F002030807360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269016See sourceNot stated by sourceXN01BBL053F002030907360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269016See sourceNot stated by sourceXN01BBL053F002031007360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269016See sourceNot stated by sourceXN01BBL053F002031107360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269016See sourceNot stated by sourceXN01BBL053F002031207360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269016See sourceNot stated by sourceXN01BBL053F002031307360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269016See sourceNot stated by sourceXN01BBL053F002031407360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269016See sourceNot stated by sourceXN01BBL053F002031507360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269016See sourceNot stated by sourceXN01BBL053F002031607360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269016See sourceNot stated by sourceXN01BBL053F002031707360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269016See sourceNot stated by sourceXN01BBL053F002031807360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269016See sourceNot stated by sourceXN01BBL053F002031907360NHSA
Guangzhou Lang Sheng Pharma Co., Ltd. romanized国药准字H20269016See sourceNot stated by sourceXN01BBL053F002032007360NHSA
Sichuan Hai Si Ke Pharmaceutical Co., Ltd. romanized国药准字H20233544See sourceNot stated by sourceXN01BBL053F002040179282NHSA

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: 24 filings and 15 distinct first applicants.

Generic 10 · Supplement 14

Current under-review applications
Company / applicantAcceptance numberApplication typeAcceptedStrength / specificationView source
Jilin Sheng Qi Jian Bio Technology Co., Ltd. romanized; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanizedCYHS2502722Generic2025/07/30Not stated by sourceCDE
Beijing Zhong Tai Bang Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanizedCYHB2601490Supplement2026/08/04Not stated by sourceCDE
Jiangsu Ying Ke Biopharmaceutical Co., Ltd. romanizedCYHB2501640Supplement2025/08/19Not stated by sourceCDE
TC Pharmaceuticals (Jiangsu) Co., LtdCYHB2601334Supplement2026/07/14Not stated by sourceCDE
TC Pharmaceuticals (Jiangsu) Co., LtdCYHB2501935Supplement2025/09/29Not stated by sourceCDE
Zhejiang AngLiKang Pharmaceutical CO.,LTD.CYHB2601917Supplement2026/10/21Not stated by sourceCDE
Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanizedCYHB2601716Supplement2026/09/10Not stated by sourceCDE
Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanizedCYHB2601715Supplement2026/09/10Not stated by sourceCDE
Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanizedCYHB2601714Supplement2026/09/10Not stated by sourceCDE
Hainan He Rui Da Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanizedCYHB2601198Supplement2026/06/26Not stated by sourceCDE
Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanized; Shandong Nuo He Kang Pharma Co., Ltd. romanizedCYHS2601330Generic2026/06/08Not stated by sourceCDE
Hunan Jiudian Pharmaceutical Co., LtdCYHB2601048Supplement2026/06/04Not stated by sourceCDE
Hunan Jiudian Pharmaceutical Co., LtdCYHB2601047Supplement2026/06/04Not stated by sourceCDE
Guo Da (Jilin) Pharmaceutical Group Co., Ltd. romanized; Nanchang Li Jian Pharma Co., Ltd. romanizedCYHS2600718Generic2026/03/26Not stated by sourceCDE
Shenzhen Shi Yu Jian Biopharmaceuticals Co., Ltd. romanized; Shenzhen Shi Xin Yang Wei Kang Technology Co., Ltd. romanizedCYHS2504321Generic2025/12/19Not stated by sourceCDE
Shenzhen Shi Yu Jian Biopharmaceuticals Co., Ltd. romanized; Shenzhen Shi Xin Yang Wei Kang Technology Co., Ltd. romanizedCYHS2504320Generic2025/12/19Not stated by sourceCDE
Shenzhen Shi Yu Jian Biopharmaceuticals Co., Ltd. romanized; Shenzhen Shi Xin Yang Wei Kang Technology Co., Ltd. romanizedCYHS2504319Generic2025/12/19Not stated by sourceCDE
Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanizedCYHS2504234Generic2025/12/10Not stated by sourceCDE
Hebei Hua Chen Pharma Group Co., Ltd. romanizedCYHS2502695Generic2025/07/25Not stated by sourceCDE
Hebei Hua Chen Pharma Group Co., Ltd. romanizedCYHS2502694Generic2025/07/25Not stated by sourceCDE
Ha Yao Group Bio Gong Cheng Co., Ltd. romanizedCYHS2602610Generic2026/10/23Not stated by sourceCDE
Guangzhou Lang Sheng Pharma Co., Ltd. romanizedCYHB2601983Supplement2026/10/29Not stated by sourceCDE
Guangzhou Lang Sheng Pharma Co., Ltd. romanizedCYHB2601982Supplement2026/10/29Not stated by sourceCDE
Guangzhou Lang Sheng Pharma Co., Ltd. romanizedCYHB2601981Supplement2026/10/29Not 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
Chongqing Kang Ke Er Pharmaceutical Co., Ltd. romanized; Shandong Nuo He Kang Pharma Co., Ltd. romanizedCYHS2601330Generic2026/06/08Not stated by sourceCDE
Guo Da (Jilin) Pharmaceutical Group Co., Ltd. romanized; Nanchang Li Jian Pharma Co., Ltd. romanizedCYHS2600718Generic2026/03/26Not stated by sourceCDE
Ha Yao Group Bio Gong Cheng Co., Ltd. romanizedCYHS2602610Generic2026/10/23Not stated by sourceCDE
API registrations

Non-component matches: 0 companies with A status and 0 I-status records. Component matches are listed separately and excluded from these counts.

NameCompany / applicantRegistration numberStatusName matchSource update dateView source
No matching records were found in the currently loaded source data; coverage dates are listed below.

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. 2026/11/12No longer listed under review

    Guangdong Tai En Kang Pharmaceutical Factory Co., Ltd. romanized

    CYHS2501621

    Fact date: 2026/11/12 · Site observation date: 2026/11/12

    Accepted: 2025/04/30

    not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

    View source ↗
  2. 2026/10/29Accepted

    Guangzhou Lang Sheng Pharma Co., Ltd. romanized

    CYHB2601983

    Fact date: 2026/10/29 · Site observation date: 2026/10/30

    View source ↗
  3. 2026/10/29Accepted

    Guangzhou Lang Sheng Pharma Co., Ltd. romanized

    CYHB2601982

    Fact date: 2026/10/29 · Site observation date: 2026/10/30

    View source ↗
  4. 2026/10/29Accepted

    Guangzhou Lang Sheng Pharma Co., Ltd. romanized

    CYHB2601981

    Fact date: 2026/10/29 · Site observation date: 2026/10/30

    View source ↗
  5. 2026/10/23Accepted

    Ha Yao Group Bio Gong Cheng Co., Ltd. romanized

    CYHS2602610

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

    View source ↗
  6. 2026/10/21Accepted

    Zhejiang AngLiKang Pharmaceutical CO.,LTD.

    CYHB2601917

    Fact date: 2026/10/21 · Site observation date: 2026/10/22

    View source ↗
  7. 2026/09/11Accepted

    Le Fu Si Health Industry Shareholding Company romanized; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanized

    CYHB2601728

    Fact date: 2026/09/11 · Site observation date: 2026/10/21

    View source ↗
  8. 2026/09/10Accepted

    Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized

    CYHB2601716

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

    View source ↗
  9. 2026/09/10Accepted

    Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized

    CYHB2601715

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

    View source ↗
  10. 2026/09/10Accepted

    Hangzhou Ling Ye Pharmaceuticals Technology Co., Ltd. romanized

    CYHB2601714

    Fact date: 2026/09/10 · 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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