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As of 13 November 2026, for Mupirocin Ointment, 30 applications are listed as under review at China's CDE; 16 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: Marketing application approved: 4 applicationsAccepted: 10 applicationsNo longer listed under review: 3 applicationsSupplement delivery: 1 application
Current coverage may be incomplete
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: Ointment. 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 name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| BACTROBAN | GLAXOSMITHKLINE | NDA 050591 · Product no. 001 | OINTMENT | TOPICAL | DISCONTINUED | 1987/12/31 |
| CENTANY | PADAGIS US LLC | NDA 050788 · Product no. 001 | OINTMENT | TOPICAL | DISCONTINUED | 2002/12/04 |
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.
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 holders0View records ↓
Under-review filings30View records ↓
This year’s generic filers16View records ↓
NHSA approval numbers33View records ↓
API companies with A status9View records ↓
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 holder | Manufacturer | Approval number | Approved | Strength / specification | Catalogue 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: 33 distinct approval numbers and 31 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H20264191 | 2%(10g:0.2g) | Category B | XD06AXM119F001010100014 | NHSA |
| Beijing Xie He Pharmaceutical Factory romanized | 国药准字H20183302 | 2% | Category B | XD06AXM119F001010100190 | NHSA |
| Guangdong Heng Jian Pharmaceutical Co., Ltd. romanized | 国药准字H20183294 | 2% | Category B | XD06AXM119F001010100443 | NHSA |
| Zhuhai Lian Bang Pharmaceutical Co., Ltd. Zhong Shan Branch romanized | 国药准字H20249649 | 2%(5g:0.1g) | Category B | XD06AXM119F001010100600 | NHSA |
| Zhong Mei Tianjin Shi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H10930064 | 2% | Category B | XD06AXM119F001010100969 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20244094 | 2%(15g:0.3g) | Category B | XD06AXM119F001010101503 | NHSA |
| Suzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanized | 国药准字H20265328 | 2%(10g:0.2g) | Category B | XD06AXM119F001010101669 | NHSA |
| Hebei Xin Zhang Yao Co., Ltd. romanized | 国药准字H20263038 | 2%(15g:0.3g) | Category B | XD06AXM119F001010102673 | NHSA |
| Henan Ling Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20249203 | 2%(15g:0.3g) | Category B | XD06AXM119F001010103050 | NHSA |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | 国药准字H20243332 | 2%(15g:0.3g) | Category B | XD06AXM119F001010104121 | NHSA |
| Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized | 国药准字H20173389 | 2% | Category B | XD06AXM119F001010104522 | NHSA |
| Hunan Ming Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20263942 | 2%(15g:0.3g) | Category B | XD06AXM119F001010105001 | NHSA |
| Jiangxi Shimei Pharmaceutical Co., Ltd | 国药准字H20255675 | 2%(15g:0.3g) | Category B | XD06AXM119F001010105356 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20193036 | 2%(5g:0.1g) | Category B | XD06AXM119F001010105765 | NHSA |
| Hainan Hai Shen Tong Zhou Pharmaceutical Co., Ltd. romanized | 国药准字H20264018 | 2%(15g:0.3g) | Category B | XD06AXM119F001010105777 | NHSA |
| Li Cai Gansu Xi Feng Pharmaceutical Co., Ltd. romanized | 国药准字H20253043 | 2%(15g:0.3g) | Category B | XD06AXM119F001010109579 | NHSA |
| Hubei Cheng Tian Pharma Co., Ltd. romanized | 国药准字H20133067 | 2% | Category B | XD06AXM119F001010109664 | NHSA |
| Ao Mei Pharmaceutical Factory Co., Ltd. romanized | 国药准字HC20160015 | 2% | Category B | XD06AXM119F001010179136 | NHSA |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H20213852 | 2% | Category B | XD06AXM119F001010180651 | NHSA |
| Hubei Shu Huo Pharma Co., Ltd. romanized | 国药准字H20263313 | 2%(15g:0.3g) | Category B | XD06AXM119F001010181004 | NHSA |
| Jiangsu Ziyond Pharmaceutical Co., Ltd. | 国药准字H20249432 | 2%(15g:0.3g) | Category B | XD06AXM119F001010181475 | NHSA |
| Wuhan Jiang Cheng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20244211 | See source | Category B | XD06AXM119F001010181917 | NHSA |
| Beijing Jing Feng Pharmaceutical (Hebei) Co., Ltd. romanized | 国药准字H20183001 | 2%(5g: 0.1g) | Category B | XD06AXM119F001010182204 | NHSA |
| Beijing Bao Nian Tang (He Ze) Pharma Co., Ltd. romanized | 国药准字H20263390 | 2%(15g:0.3g) | Category B | XD06AXM119F001010183549 | NHSA |
| Hainan Zi Cheng Zhong Tou Bio Technology Co., Ltd. romanized | 国药准字H20254083 | 2%(15g:0.3g) | Category B | XD06AXM119F001010184112 | NHSA |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254639 | See source | Category B | XD06AXM119F001010184221 | NHSA |
| Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20255889 | 2%(10g:0.2g) | Category B | XD06AXM119F001010184225 | NHSA |
| Suzhou Gao Mai Pharma Co., Ltd. romanized | 国药准字H20265065 | See source | Category B | XD06AXM119F001010184410 | NHSA |
| Shenzhen Shi Tai Li Biopharmaceuticals Co., Ltd. romanized | 国药准字H20255125 | 2%(15g:0.3g) | Category B | XD06AXM119F001010184696 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253011 | 2%(15g:0.3g) | Category B | XD06AXM119F001010185032 | NHSA |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | 国药准字H20243332 | 2%(15g:0.3g) | Category B | XD06AXM119F001010204121 | NHSA |
| Ao Mei Pharmaceutical Factory Co., Ltd. romanized | 国药准字HC20160015 | 2% | Category B | XD06AXM119F001010279136 | NHSA |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H20213852 | 2% | Category B | XD06AXM119F001010280651 | NHSA |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254639 | See source | Category B | XD06AXM119F001010284221 | NHSA |
| Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254639 | See source | Category B | XD06AXM119F001010384221 | NHSA |
| Guangdong Heng Jian Pharmaceutical Co., Ltd. romanized | 国药准字H20183294 | 2% | Category B | XD06AXM119F001020100443 | NHSA |
| Zhong Mei Tianjin Shi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H10930064 | 2% | Category B | XD06AXM119F001020100969 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20269201 | 2%(10g:0.2g) | Category B | XD06AXM119F001020101503 | NHSA |
| Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized | 国药准字H20173389 | 2% | Category B | XD06AXM119F001020104522 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20193036 | 2%(5g:0.1g) | Category B | XD06AXM119F001020105765 | NHSA |
| Hubei Cheng Tian Pharma Co., Ltd. romanized | 国药准字H20133067 | 2% | Category B | XD06AXM119F001020109664 | NHSA |
| Ao Mei Pharmaceutical Factory Co., Ltd. romanized | 国药准字HC20160015 | 2% | Category B | XD06AXM119F001020179136 | NHSA |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H20213852 | 2% | Category B | XD06AXM119F001020180651 | NHSA |
| Hubei Shu Huo Pharma Co., Ltd. romanized | 国药准字H20263313 | 2%(15g:0.3g) | Category B | XD06AXM119F001020181004 | NHSA |
| Beijing Jing Feng Pharmaceutical (Hebei) Co., Ltd. romanized | 国药准字H20183001 | 2%(5g: 0.1g) | Category B | XD06AXM119F001020182204 | NHSA |
| Shenzhen Shi Tai Li Biopharmaceuticals Co., Ltd. romanized | 国药准字H20255125 | 2%(15g:0.3g) | Category B | XD06AXM119F001020184696 | NHSA |
| Guangdong Heng Jian Pharmaceutical Co., Ltd. romanized | 国药准字H20183294 | 2% | Category B | XD06AXM119F001030100443 | NHSA |
| Zhong Mei Tianjin Shi Ke Pharmaceutical Co., Ltd. romanized | 国药准字H10930064 | 2% | Category B | XD06AXM119F001030100969 | NHSA |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20269202 | 2%(5g:0.1g) | Category B | XD06AXM119F001030101503 | NHSA |
| Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized | 国药准字H20173389 | 2% | Category B | XD06AXM119F001030104522 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20193036 | 2%(5g:0.1g) | Category B | XD06AXM119F001030105765 | NHSA |
| Hubei Cheng Tian Pharma Co., Ltd. romanized | 国药准字H20133067 | 2% | Category B | XD06AXM119F001030109664 | NHSA |
| Ao Mei Pharmaceutical Factory Co., Ltd. romanized | 国药准字HC20160015 | 2% | Category B | XD06AXM119F001030179136 | NHSA |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H20213852 | 2% | Category B | XD06AXM119F001030180651 | NHSA |
| Beijing Jing Feng Pharmaceutical (Hebei) Co., Ltd. romanized | 国药准字H20183001 | 2%(5g: 0.1g) | Category B | XD06AXM119F001030182204 | NHSA |
| Shenzhen Shi Tai Li Biopharmaceuticals Co., Ltd. romanized | 国药准字H20255125 | 2%(15g:0.3g) | Category B | XD06AXM119F001030184696 | NHSA |
| Ao Mei Pharmaceutical Factory Co., Ltd. romanized | 国药准字HC20160015 | 2% | Category B | XD06AXM119F001030279136 | NHSA |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H20213852 | 2% | Category B | XD06AXM119F001030280651 | NHSA |
| Guangdong Heng Jian Pharmaceutical Co., Ltd. romanized | 国药准字H20183294 | 2% | Category B | XD06AXM119F001040100443 | NHSA |
| Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized | 国药准字H20173389 | 2% | Category B | XD06AXM119F001040104522 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20193036 | 2%(5g:0.1g) | Category B | XD06AXM119F001040105765 | NHSA |
| Hubei Cheng Tian Pharma Co., Ltd. romanized | 国药准字H20133067 | 2% | Category B | XD06AXM119F001040109664 | NHSA |
| Ao Mei Pharmaceutical Factory Co., Ltd. romanized | 国药准字HC20160015 | 2% | Category B | XD06AXM119F001040179136 | NHSA |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H20213852 | 2% | Category B | XD06AXM119F001040180651 | NHSA |
| Beijing Jing Feng Pharmaceutical (Hebei) Co., Ltd. romanized | 国药准字H20183001 | 2%(5g: 0.1g) | Category B | XD06AXM119F001040182204 | NHSA |
| Guangdong Heng Jian Pharmaceutical Co., Ltd. romanized | 国药准字H20183294 | 2% | Category B | XD06AXM119F001050100443 | NHSA |
| Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized | 国药准字H20173389 | 2% | Category B | XD06AXM119F001050104522 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20193036 | 2%(5g:0.1g) | Category B | XD06AXM119F001050105765 | NHSA |
| Hubei Cheng Tian Pharma Co., Ltd. romanized | 国药准字H20133067 | 2% | Category B | XD06AXM119F001050109664 | NHSA |
| Fu Yuan Pharma Co., Ltd. romanized | 国药准字H20213852 | 2% | Category B | XD06AXM119F001050180651 | NHSA |
| Beijing Jing Feng Pharmaceutical (Hebei) Co., Ltd. romanized | 国药准字H20183001 | 2%(5g: 0.1g) | Category B | XD06AXM119F001050182204 | NHSA |
| Hubei Cheng Tian Pharma Co., Ltd. romanized | 国药准字H20133067 | 2% | Category B | XD06AXM119F001050209664 | NHSA |
| Guangdong Heng Jian Pharmaceutical Co., Ltd. romanized | 国药准字H20183294 | 2% | Category B | XD06AXM119F001060100443 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20193036 | 2%(5g:0.1g) | Category B | XD06AXM119F001060105765 | NHSA |
| Hubei Cheng Tian Pharma Co., Ltd. romanized | 国药准字H20133067 | 2% | Category B | XD06AXM119F001060109664 | NHSA |
| Beijing Jing Feng Pharmaceutical (Hebei) Co., Ltd. romanized | 国药准字H20183001 | 2%(5g: 0.1g) | Category B | XD06AXM119F001060182204 | NHSA |
| Guangdong Heng Jian Pharmaceutical Co., Ltd. romanized | 国药准字H20183294 | 2% | Category B | XD06AXM119F001070100443 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20193036 | 2%(5g:0.1g) | Category B | XD06AXM119F001070105765 | NHSA |
| Hubei Cheng Tian Pharma Co., Ltd. romanized | 国药准字H20133067 | 2% | Category B | XD06AXM119F001070109664 | NHSA |
| Beijing Jing Feng Pharmaceutical (Hebei) Co., Ltd. romanized | 国药准字H20183001 | 2%(5g: 0.1g) | Category B | XD06AXM119F001070182204 | NHSA |
| Hubei Cheng Tian Pharma Co., Ltd. romanized | 国药准字H20133067 | 2% | Category B | XD06AXM119F001070209664 | NHSA |
| Guangdong Heng Jian Pharmaceutical Co., Ltd. romanized | 国药准字H20183294 | 2% | Category B | XD06AXM119F001080100443 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20193036 | 2%(5g:0.1g) | Category B | XD06AXM119F001080105765 | NHSA |
| Hubei Cheng Tian Pharma Co., Ltd. romanized | 国药准字H20133067 | 2% | Category B | XD06AXM119F001080109664 | NHSA |
| Beijing Jing Feng Pharmaceutical (Hebei) Co., Ltd. romanized | 国药准字H20183001 | 2%(5g: 0.1g) | Category B | XD06AXM119F001080182204 | NHSA |
| Beijing Jing Feng Pharmaceutical (Hebei) Co., Ltd. romanized | 国药准字H20183001 | 2%(5g: 0.1g) | Category B | XD06AXM119F001090182204 | NHSA |
| Beijing Jing Feng Pharmaceutical (Hebei) Co., Ltd. romanized | 国药准字H20183001 | 2%(5g: 0.1g) | Category B | XD06AXM119F001100182204 | NHSA |
| Guizhou Lian Sheng Pharma Co., Ltd. romanized | 国药准字H20253638 | 2%(15g:0.3g) | Category B | XD06AXM119F001010185280 | 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: 30 filings and 25 distinct first applicants.
Generic 26 · Supplement 4
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| TC Pharmaceuticals (Jiangsu) Co., Ltd | CYHS2600951 | Generic | 2026/04/23 | Not stated by source | CDE |
| Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Nanjing Chen Gong Pharmaceutical Co., Ltd. romanized | CYHS2601044 | Generic | 2026/05/08 | Not stated by source | CDE |
| Suzhou Di Si Pharmaceutical Factory Co., Ltd. romanized | CYHS2501859 | Generic | 2025/05/23 | Not stated by source | CDE |
| Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized | CYHS2602477 | Generic | 2026/10/10 | Not stated by source | CDE |
| Henan Da Xin Pharma Co., Ltd. romanized | CYHS2602452 | Generic | 2026/10/09 | Not stated by source | CDE |
| Zhejiang De En De Pharmaceutical Co., Ltd. romanized | CYHS2602338 | Generic | 2026/09/18 | Not stated by source | CDE |
| Zhejiang De En De Pharmaceutical Co., Ltd. romanized | CYHS2602337 | Generic | 2026/09/18 | Not stated by source | CDE |
| Zhejiang De En De Pharmaceutical Co., Ltd. romanized | CYHS2602336 | Generic | 2026/09/18 | Not stated by source | CDE |
| Hubei Ke Yi Pharma Co., Ltd. romanized | CYHS2602173 | Generic | 2026/09/01 | Not stated by source | CDE |
| Hangzhou Wan Bang Tian Cheng Pharma Co., Ltd. romanized | CYHS2602132 | Generic | 2026/08/26 | Not stated by source | CDE |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | CYHS2602010 | Generic | 2026/08/13 | Not stated by source | CDE |
| Shanghai Xiao Fang Pharmaceutical Co., Ltd. romanized | CYHS2601931 | Generic | 2026/08/07 | Not stated by source | CDE |
| Shenzhen Shi Tai Li Biopharmaceuticals Co., Ltd. romanized; Shenzhen Shi Xin Yang Wei Kang Technology Co., Ltd. romanized | CYHB2601461 | Supplement | 2026/07/30 | Not stated by source | CDE |
| Shenzhen Shi Tai Li Biopharmaceuticals Co., Ltd. romanized; Shenzhen Shi Xin Yang Wei Kang Technology Co., Ltd. romanized | CYHB2601460 | Supplement | 2026/07/30 | Not stated by source | CDE |
| Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized | CYHS2601655 | Generic | 2026/07/10 | Not stated by source | CDE |
| Chengdu Ya Tu Bio Technology Co., Ltd. romanized; Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | CYHS2601422 | Generic | 2026/06/16 | Not stated by source | CDE |
| Jiangxi Shimei Pharmaceutical Co., Ltd | CYHB2601110 | Supplement | 2026/06/12 | Not stated by source | CDE |
| Jiangxi Shimei Pharmaceutical Co., Ltd | CYHB2601109 | Supplement | 2026/06/12 | Not stated by source | CDE |
| Jiangxi Pu Li Er Pharma Co., Ltd. romanized | CYHS2601302 | Generic | 2026/06/04 | Not stated by source | CDE |
| Heilongjiang Tian Chen Pharma Co., Ltd. romanized | CYHS2600720 | Generic | 2026/03/26 | Not stated by source | CDE |
| Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized | CYHS2600154 | Generic | 2026/01/13 | Not stated by source | CDE |
| Jiangxi Ji An San Li Pharmaceutical Co., Ltd. romanized | CYHS2600053 | Generic | 2026/01/06 | Not stated by source | CDE |
| Hunan Jiudian Pharmaceutical Co., Ltd | CYHS2600010 | Generic | 2026/01/05 | Not stated by source | CDE |
| Tang Shan Hong Xing Pharma Co., Ltd. romanized | CYHS2504158 | Generic | 2025/12/03 | Not stated by source | CDE |
| Fujian Tai Ping Yang Pharmaceutical Co., Ltd. romanized | CYHS2504119 | Generic | 2025/12/02 | Not stated by source | CDE |
| Zhejiang Kang Run Pharmaceutical Co., Ltd. romanized; Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized | CYHS2503180 | Generic | 2025/08/30 | Not stated by source | CDE |
| Sui Cheng Pharma Co., Ltd. romanized | CYHS2503134 | Generic | 2025/08/27 | Not stated by source | CDE |
| Hubei Chang Jiang Rui Yi Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CYHS2503063 | Generic | 2025/08/20 | Not stated by source | CDE |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | CYHS2502835 | Generic | 2025/08/06 | Not stated by source | CDE |
| Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized | CYHS2502834 | Generic | 2025/08/06 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 18 filings and 16 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| TC Pharmaceuticals (Jiangsu) Co., Ltd | CYHS2600951 | Generic | 2026/04/23 | Not stated by source | CDE |
| Hainan Feng Kai Si Pharmaceutical Co., Ltd. romanized; Nanjing Chen Gong Pharmaceutical Co., Ltd. romanized | CYHS2601044 | Generic | 2026/05/08 | Not stated by source | CDE |
| Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized | CYHS2602477 | Generic | 2026/10/10 | Not stated by source | CDE |
| Henan Da Xin Pharma Co., Ltd. romanized | CYHS2602452 | Generic | 2026/10/09 | Not stated by source | CDE |
| Zhejiang De En De Pharmaceutical Co., Ltd. romanized | CYHS2602338 | Generic | 2026/09/18 | Not stated by source | CDE |
| Zhejiang De En De Pharmaceutical Co., Ltd. romanized | CYHS2602337 | Generic | 2026/09/18 | Not stated by source | CDE |
| Zhejiang De En De Pharmaceutical Co., Ltd. romanized | CYHS2602336 | Generic | 2026/09/18 | Not stated by source | CDE |
| Hubei Ke Yi Pharma Co., Ltd. romanized | CYHS2602173 | Generic | 2026/09/01 | Not stated by source | CDE |
| Hangzhou Wan Bang Tian Cheng Pharma Co., Ltd. romanized | CYHS2602132 | Generic | 2026/08/26 | Not stated by source | CDE |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | CYHS2602010 | Generic | 2026/08/13 | Not stated by source | CDE |
| Shanghai Xiao Fang Pharmaceutical Co., Ltd. romanized | CYHS2601931 | Generic | 2026/08/07 | Not stated by source | CDE |
| Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized | CYHS2601655 | Generic | 2026/07/10 | Not stated by source | CDE |
| Chengdu Ya Tu Bio Technology Co., Ltd. romanized; Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | CYHS2601422 | Generic | 2026/06/16 | Not stated by source | CDE |
| Jiangxi Pu Li Er Pharma Co., Ltd. romanized | CYHS2601302 | Generic | 2026/06/04 | Not stated by source | CDE |
| Heilongjiang Tian Chen Pharma Co., Ltd. romanized | CYHS2600720 | Generic | 2026/03/26 | Not stated by source | CDE |
| Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized | CYHS2600154 | Generic | 2026/01/13 | Not stated by source | CDE |
| Jiangxi Ji An San Li Pharmaceutical Co., Ltd. romanized | CYHS2600053 | Generic | 2026/01/06 | Not stated by source | CDE |
| Hunan Jiudian Pharmaceutical Co., Ltd | CYHS2600010 | Generic | 2026/01/05 | Not stated by source | CDE |
API registrations
Non-component matches: 9 companies with A status and 2 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 |
|---|---|---|---|---|---|---|
| 莫匹罗星 · No verified English name | Topfond Pharmaceutical Co., Ltd. | Y20250000248 | I | Exact ingredient | 2025/04/02 | CDE |
| 莫匹罗星 · No verified English name | Zhejiang Rui Bang Pharma Co., Ltd. romanized | Y20240001329 | A | Exact ingredient | 2026/08/25 | CDE |
| 莫匹罗星 · No verified English name | Sheng Zhan Bio Technology Co., Ltd. romanized | Y20230001100 | A | Exact ingredient | 2026/04/21 | CDE |
| 莫匹罗星 · No verified English name | Fujian Kang Hong Bio Technology Co., Ltd. romanized | Y20240000479 | A | Exact ingredient | 2025/11/21 | CDE |
| 莫匹罗星 · No verified English name | Sichuan Nuo Yi Sheng Pharma Co., Ltd. romanized | Y20240000116 | A | Exact ingredient | 2025/11/01 | CDE |
| 莫匹罗星 · No verified English name | Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized | Y20210000384 | A | Exact ingredient | 2024/11/07 | CDE |
| 莫匹罗星 · No verified English name | Concord Biotech Limited | Y20200001497 | A | Exact ingredient | 2025/11/03 | CDE |
| 莫匹罗星 · No verified English name | Bill Biotech Pvt，Ltd. | Y20210000048 | I | Exact ingredient | 2021/03/15 | CDE |
| 莫匹罗星 · No verified English name | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | Y20190009554 | A | Exact ingredient | — | CDE |
| 莫匹罗星 · No verified English name | TAPI Hungary Industries Ltd. | Y20190009298 | A | Exact ingredient | 2025/05/01 | CDE |
| 莫匹罗星 · No verified English name | SmithKline Beecham Limited | Y20190009171 | A | Exact ingredient | — | CDE |
| 莫匹罗星 · No verified English name | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | Y20190000308 | A | Exact ingredient | 2025/04/04 | 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.
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.
-
2026/11/13No longer listed under review
Jia Ying Pharmaceutical (Hunan) Co., Ltd. romanized; Chi Feng Sai Lin Tai Pharma Co., Ltd. romanized
CYHB2601951
Fact date: 2026/11/13 · Site observation date: 2026/11/13
Accepted: 2026/10/23
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/11/03Marketing application approved
Hubei Wu Shi Pharma Co., Ltd. romanized
CYHS2501140 · 国药准字H20266428
Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06
The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.
View source · Table row 44 ↗ -
2026/11/03Marketing application approved
Hubei Wu Shi Pharma Co., Ltd. romanized
CYHS2501138 · 国药准字H20266461
Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06
The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.
View source · Table row 43 ↗ -
2026/11/03Marketing application approved
Hubei Wu Shi Pharma Co., Ltd. romanized
CYHS2501137 · 国药准字H20266446
Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06
The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.
View source · Table row 42 ↗ -
2026/11/03Marketing application approved
Hubei Ke Tian Pharma Co., Ltd. romanized
CYHS2500926 · 国药准字H20266459
Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06
The loaded NHSA codes and chemical-drug catalogue contain no evidence confirming an earlier same-name approval for this company. This does not establish the absence of an earlier approval.
View source · Table row 34 ↗ -
2026/10/29No longer listed under review
Suzhou Tian Ma Pharmaceuticals Group Tian Ji Biopharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
CYHS2501705
Fact date: 2026/10/29 · Site observation date: 2026/10/29
Accepted: 2025/05/11
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/10/28No longer listed under review
Bao Long Pharma Co., Ltd. romanized
CYHS2403956
Fact date: 2026/10/28 · Site observation date: 2026/10/28
Accepted: 2024/11/18
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/10/23Accepted
Jia Ying Pharmaceutical (Hunan) Co., Ltd. romanized; Chi Feng Sai Lin Tai Pharma Co., Ltd. romanized
CYHB2601951
Fact date: 2026/10/23 · Site observation date: 2026/10/24
View source ↗ -
2026/10/16Supplement delivery
Guizhou Lian Sheng Pharma Co., Ltd. romanized
CYHB2601713
Fact date: 2026/10/16 · Publication date: 2026/10/19 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 8 ↗ -
2026/10/10Accepted
Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized
CYHS2602477
Fact date: 2026/10/10 · Site observation date: 2026/10/22
View source ↗ -
2026/10/09Accepted
Henan Da Xin Pharma Co., Ltd. romanized
CYHS2602452
Fact date: 2026/10/09 · Site observation date: 2026/10/22
View source ↗ -
2026/09/18Accepted
Zhejiang De En De Pharmaceutical Co., Ltd. romanized
CYHS2602338
Fact date: 2026/09/18 · Site observation date: 2026/10/22
View source ↗ -
2026/09/18Accepted
Zhejiang De En De Pharmaceutical Co., Ltd. romanized
CYHS2602337
Fact date: 2026/09/18 · Site observation date: 2026/10/22
View source ↗ -
2026/09/18Accepted
Zhejiang De En De Pharmaceutical Co., Ltd. romanized
CYHS2602336
Fact date: 2026/09/18 · Site observation date: 2026/10/22
View source ↗ -
2026/09/10Accepted
Guizhou Lian Sheng Pharma Co., Ltd. romanized; Yao Yuan Bio Technology (Qi Dong) Co., Ltd. romanized
CYHB2601713
Fact date: 2026/09/10 · Site observation date: 2026/10/21
View source ↗ -
2026/09/01Accepted
Hubei Ke Yi Pharma Co., Ltd. romanized
CYHS2602173
Fact date: 2026/09/01 · Site observation date: 2026/10/22
View source ↗ -
2026/08/26Accepted
Hangzhou Wan Bang Tian Cheng Pharma Co., Ltd. romanized
CYHS2602132
Fact date: 2026/08/26 · Site observation date: 2026/10/22
View source ↗ -
2026/08/20Accepted
Beijing Bao Nian Tang (He Ze) Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
CYHB2601573
Fact date: 2026/08/20 · Site observation date: 2026/10/22
View source ↗
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/13 06:42
- Chemical-drug catalogue
- Last successful update: 2026/11/13 06:39
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
- Full API register
- Last successful update: 2026/11/13 06:41
- NHSA drug codes
- Last successful update: 2026/11/05 06:45
The fully loaded edition was maintained to 2026-10-23. Publication lags maintenance: the verified 2026-10-16 edition was published on 10-28, a 12-day gap. This is not a fixed lag for every edition.
- NMPA drug delivery notices
- Last successful update: 2026/11/12 18:32 · Current coverage may be incomplete
First index-page publication dates: 2026-10-29 to 2026-11-13; 2 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/13 08:09 · Current coverage may be incomplete
Daily collection reads new registrations. Backfill covers registration numbers from 2025 onward (CTR2025/CTR2026), not first-publication years. States are dated observations; revisions are not tracked.
Public-product searches scanned: 7/30; discovered pending details: 13. Record counts in unscanned portions remain unknown.
Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.
Fact dates are approval dates, acceptance dates, trial first-publication dates or complete-snapshot observation dates, as applicable. Publication and site-observation dates are separate. Historical backfills are not current-period new events. Exit records cover currently inactive applications with an identifiable complete snapshot, not a full review history.
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