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Sign in to subscribeMirogabalin Besilate Tablets
As of 13 November 2026, for Mirogabalin Besilate Tablets, 61 applications are listed as under review at China's CDE; 22 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 2 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Accepted: 13 applicationsTrial registration: 15 applicationsNo longer listed under review: 1 applicationNotification delivery: 2 applications
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 holders2View records ↓
Under-review filings61View records ↓
This year’s generic filers22View records ↓
NHSA approval numbers2View records ↓
API companies with A status5View records ↓
Chemical-drug catalogue
Loaded records: 2 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 2 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 |
|---|---|---|---|---|---|---|
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20264691 | 2026/06/10 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20263603 | 2026/03/17 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20264689 | 2026/06/10 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Easton Biopharmaceuticals Co.,Ltd. | Chengdu Easton Biopharmaceuticals Co.,Ltd. | 国药准字H20264690 | 2026/06/10 | 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: 2 distinct approval numbers and 1 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| DAIICHI SANKYO CO.,LTD. | 国药准字HJ20240066 | See source | Category B | XN02BFM187A001010179008 | NHSA |
| DAIICHI SANKYO CO.,LTD. | 国药准字HJ20240067 | See source | Category B | XN02BFM187A001020179008 | 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: 61 filings and 32 distinct first applicants.
Generic 58 · Supplement 3
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Shandong Lukang Pharmaceutical Co.,Ltd. | CYHS2601398 | Generic | 2026/06/12 | Not stated by source | CDE |
| Shandong Lukang Pharmaceutical Co.,Ltd. | CYHS2601397 | Generic | 2026/06/12 | Not stated by source | CDE |
| Qilu Pharmaceutical (Hainan) Co., Ltd | CYHS2404045 | Generic | 2024/11/25 | Not stated by source | CDE |
| Qilu Pharmaceutical (Hainan) Co., Ltd | CYHS2404044 | Generic | 2024/11/25 | Not stated by source | CDE |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2602305 | Generic | 2026/09/16 | Not stated by source | CDE |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2602304 | Generic | 2026/09/16 | Not stated by source | CDE |
| Guangdong Bo Zhuo Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | CYHS2601048 | Generic | 2026/05/08 | Not stated by source | CDE |
| Guangdong Bo Zhuo Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | CYHS2601047 | Generic | 2026/05/08 | Not stated by source | CDE |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | CYHS2600198 | Generic | 2026/01/16 | Not stated by source | CDE |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | CYHS2600196 | Generic | 2026/01/16 | Not stated by source | CDE |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | CYHS2600195 | Generic | 2026/01/16 | Not stated by source | CDE |
| Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized | CYHS2600111 | Generic | 2026/01/09 | Not stated by source | CDE |
| Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized | CYHS2600109 | Generic | 2026/01/09 | Not stated by source | CDE |
| Nanjing Wan Rong Jian Cheng Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Wan He Pharmaceutical Co., Ltd. romanized | CYHS2503023 | Generic | 2025/08/19 | Not stated by source | CDE |
| Fujian Dong Rui Pharmaceutical Co., Ltd. romanized | CYHS2602540 | Generic | 2026/10/14 | Not stated by source | CDE |
| Fujian Dong Rui Pharmaceutical Co., Ltd. romanized | CYHS2602539 | Generic | 2026/10/14 | Not stated by source | CDE |
| Beijing Foyou Pharma CO.,LTD | CYHS2602195 | Generic | 2026/09/03 | Not stated by source | CDE |
| Beijing Foyou Pharma CO.,LTD | CYHS2602194 | Generic | 2026/09/03 | Not stated by source | CDE |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | CYHS2602105 | Generic | 2026/08/24 | Not stated by source | CDE |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | CYHS2602104 | Generic | 2026/08/24 | Not stated by source | CDE |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | CYHS2601981 | Generic | 2026/08/12 | Not stated by source | CDE |
| Zhong Xi (Fujian) Pharma Co., Ltd. romanized; Yao Da Pharmaceutical Co., Ltd. romanized | CYHS2601912 | Generic | 2026/08/06 | Not stated by source | CDE |
| Zhong Xi (Fujian) Pharma Co., Ltd. romanized; Yao Da Pharmaceutical Co., Ltd. romanized | CYHS2601911 | Generic | 2026/08/06 | Not stated by source | CDE |
| Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized | CYHS2601844 | Generic | 2026/07/31 | Not stated by source | CDE |
| Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized | CYHS2601843 | Generic | 2026/07/31 | Not stated by source | CDE |
| Guangzhou Yu Dong Health Pharmaceutical Co., Ltd. romanized | CYHB2601449 | Supplement | 2026/07/28 | Not stated by source | CDE |
| Hunan Jiudian Pharmaceutical Co., Ltd | CYHS2601454 | Generic | 2026/06/18 | Not stated by source | CDE |
| Hunan Jiudian Pharmaceutical Co., Ltd | CYHS2601453 | Generic | 2026/06/18 | Not stated by source | CDE |
| Topfond Pharmaceutical Co., Ltd. | CYHS2601386 | Generic | 2026/06/11 | Not stated by source | CDE |
| Topfond Pharmaceutical Co., Ltd. | CYHS2601385 | Generic | 2026/06/11 | Not stated by source | CDE |
| Topfond Pharmaceutical Co., Ltd. | CYHS2601383 | Generic | 2026/06/11 | Not stated by source | CDE |
| Jiangxi Shan Xiang Pharma Co., Ltd. romanized | CYHS2601326 | Generic | 2026/06/08 | Not stated by source | CDE |
| Hunan Yi Ge Pharmaceutical Co., Ltd. romanized | CYHS2601235 | Generic | 2026/06/01 | Not stated by source | CDE |
| Hunan Yi Ge Pharmaceutical Co., Ltd. romanized | CYHS2601234 | Generic | 2026/06/01 | Not stated by source | CDE |
| Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. | CYHS2600759 | Generic | 2026/04/01 | Not stated by source | CDE |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | CYHS2600742 | Generic | 2026/03/28 | Not stated by source | CDE |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | CYHS2600741 | Generic | 2026/03/28 | Not stated by source | CDE |
| Jiangxi Shimei Pharmaceutical Co., Ltd | CYHS2600655 | Generic | 2026/03/13 | Not stated by source | CDE |
| Jiangxi Shimei Pharmaceutical Co., Ltd | CYHS2600654 | Generic | 2026/03/13 | Not stated by source | CDE |
| Chongqing Huapont Pharmaceutical Co., Ltd. | CYHS2600604 | Generic | 2026/02/28 | Not stated by source | CDE |
| Chongqing Huapont Pharmaceutical Co., Ltd. | CYHS2600603 | Generic | 2026/02/28 | Not stated by source | CDE |
| Zhuhai Tong Yuan Pharma Co., Ltd. romanized; Guangzhou Yu Dong Health Pharmaceutical Co., Ltd. romanized | CYHS2504364 | Generic | 2025/12/24 | Not stated by source | CDE |
| Sui Cheng Pharma Co., Ltd. romanized | CYHS2504287 | Generic | 2025/12/16 | Not stated by source | CDE |
| Sui Cheng Pharma Co., Ltd. romanized | CYHS2504286 | Generic | 2025/12/16 | Not stated by source | CDE |
| Sui Cheng Pharma Co., Ltd. romanized | CYHS2504285 | Generic | 2025/12/16 | Not stated by source | CDE |
| Sui Cheng Pharma Co., Ltd. romanized | CYHS2504284 | Generic | 2025/12/16 | Not stated by source | CDE |
| Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. | CYHS2504041 | Generic | 2025/11/22 | Not stated by source | CDE |
| DAIICHI SANKYO CO. LTD.; TAIYO Pharma Tech CO. LTD. Takatsuki Plant | JYHB2500524 | Supplement | 2025/10/14 | Not stated by source | CDE |
| DAIICHI SANKYO CO. LTD.; TAIYO Pharma Tech CO. LTD. Takatsuki Plant | JYHB2500523 | Supplement | 2025/10/14 | Not stated by source | CDE |
| Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | CYHS2503412 | Generic | 2025/09/16 | Not stated by source | CDE |
| Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | CYHS2503411 | Generic | 2025/09/16 | Not stated by source | CDE |
| Hangzhou He Kang Pharma Co., Ltd. romanized | CYHS2503060 | Generic | 2025/08/20 | Not stated by source | CDE |
| Hangzhou He Kang Pharma Co., Ltd. romanized | CYHS2503059 | Generic | 2025/08/20 | Not stated by source | CDE |
| NORTH CHINA PHARMACEUTICAL COMPANY.LTD | CYHS2502850 | Generic | 2025/08/06 | Not stated by source | CDE |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | CYHS2502650 | Generic | 2025/07/23 | Not stated by source | CDE |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | CYHS2502649 | Generic | 2025/07/23 | Not stated by source | CDE |
| Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CYHS2602663 | Generic | 2026/10/30 | Not stated by source | CDE |
| Shanghai Fu Dan Fu Hua Pharma Co., Ltd. romanized | CYHS2602710 | Generic | 2026/11/05 | Not stated by source | CDE |
| Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | CYHS2602742 | Generic | 2026/11/09 | Not stated by source | CDE |
| Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | CYHS2602741 | Generic | 2026/11/09 | Not stated by source | CDE |
| Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | CYHS2602740 | Generic | 2026/11/09 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 42 filings and 22 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Shandong Lukang Pharmaceutical Co.,Ltd. | CYHS2601398 | Generic | 2026/06/12 | Not stated by source | CDE |
| Shandong Lukang Pharmaceutical Co.,Ltd. | CYHS2601397 | Generic | 2026/06/12 | Not stated by source | CDE |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2602305 | Generic | 2026/09/16 | Not stated by source | CDE |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2602304 | Generic | 2026/09/16 | Not stated by source | CDE |
| Guangdong Bo Zhuo Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | CYHS2601048 | Generic | 2026/05/08 | Not stated by source | CDE |
| Guangdong Bo Zhuo Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | CYHS2601047 | Generic | 2026/05/08 | Not stated by source | CDE |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | CYHS2600198 | Generic | 2026/01/16 | Not stated by source | CDE |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | CYHS2600196 | Generic | 2026/01/16 | Not stated by source | CDE |
| Jiangsu Lianhuan Pharmaceutical Co.,Ltd. | CYHS2600195 | Generic | 2026/01/16 | Not stated by source | CDE |
| Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized | CYHS2600111 | Generic | 2026/01/09 | Not stated by source | CDE |
| Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized | CYHS2600109 | Generic | 2026/01/09 | Not stated by source | CDE |
| Fujian Dong Rui Pharmaceutical Co., Ltd. romanized | CYHS2602540 | Generic | 2026/10/14 | Not stated by source | CDE |
| Fujian Dong Rui Pharmaceutical Co., Ltd. romanized | CYHS2602539 | Generic | 2026/10/14 | Not stated by source | CDE |
| Beijing Foyou Pharma CO.,LTD | CYHS2602195 | Generic | 2026/09/03 | Not stated by source | CDE |
| Beijing Foyou Pharma CO.,LTD | CYHS2602194 | Generic | 2026/09/03 | Not stated by source | CDE |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | CYHS2602105 | Generic | 2026/08/24 | Not stated by source | CDE |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | CYHS2602104 | Generic | 2026/08/24 | Not stated by source | CDE |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | CYHS2601981 | Generic | 2026/08/12 | Not stated by source | CDE |
| Zhong Xi (Fujian) Pharma Co., Ltd. romanized; Yao Da Pharmaceutical Co., Ltd. romanized | CYHS2601912 | Generic | 2026/08/06 | Not stated by source | CDE |
| Zhong Xi (Fujian) Pharma Co., Ltd. romanized; Yao Da Pharmaceutical Co., Ltd. romanized | CYHS2601911 | Generic | 2026/08/06 | Not stated by source | CDE |
| Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized | CYHS2601844 | Generic | 2026/07/31 | Not stated by source | CDE |
| Shandong Dan Hong Pharmaceutical Co., Ltd. romanized; Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized | CYHS2601843 | Generic | 2026/07/31 | Not stated by source | CDE |
| Hunan Jiudian Pharmaceutical Co., Ltd | CYHS2601454 | Generic | 2026/06/18 | Not stated by source | CDE |
| Hunan Jiudian Pharmaceutical Co., Ltd | CYHS2601453 | Generic | 2026/06/18 | Not stated by source | CDE |
| Topfond Pharmaceutical Co., Ltd. | CYHS2601386 | Generic | 2026/06/11 | Not stated by source | CDE |
| Topfond Pharmaceutical Co., Ltd. | CYHS2601385 | Generic | 2026/06/11 | Not stated by source | CDE |
| Topfond Pharmaceutical Co., Ltd. | CYHS2601383 | Generic | 2026/06/11 | Not stated by source | CDE |
| Jiangxi Shan Xiang Pharma Co., Ltd. romanized | CYHS2601326 | Generic | 2026/06/08 | Not stated by source | CDE |
| Hunan Yi Ge Pharmaceutical Co., Ltd. romanized | CYHS2601235 | Generic | 2026/06/01 | Not stated by source | CDE |
| Hunan Yi Ge Pharmaceutical Co., Ltd. romanized | CYHS2601234 | Generic | 2026/06/01 | Not stated by source | CDE |
| Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. | CYHS2600759 | Generic | 2026/04/01 | Not stated by source | CDE |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | CYHS2600742 | Generic | 2026/03/28 | Not stated by source | CDE |
| Jewim Pharmaceutical (Shandong) Co., Ltd. | CYHS2600741 | Generic | 2026/03/28 | Not stated by source | CDE |
| Jiangxi Shimei Pharmaceutical Co., Ltd | CYHS2600655 | Generic | 2026/03/13 | Not stated by source | CDE |
| Jiangxi Shimei Pharmaceutical Co., Ltd | CYHS2600654 | Generic | 2026/03/13 | Not stated by source | CDE |
| Chongqing Huapont Pharmaceutical Co., Ltd. | CYHS2600604 | Generic | 2026/02/28 | Not stated by source | CDE |
| Chongqing Huapont Pharmaceutical Co., Ltd. | CYHS2600603 | Generic | 2026/02/28 | Not stated by source | CDE |
| Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CYHS2602663 | Generic | 2026/10/30 | Not stated by source | CDE |
| Shanghai Fu Dan Fu Hua Pharma Co., Ltd. romanized | CYHS2602710 | Generic | 2026/11/05 | Not stated by source | CDE |
| Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | CYHS2602742 | Generic | 2026/11/09 | Not stated by source | CDE |
| Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | CYHS2602741 | Generic | 2026/11/09 | Not stated by source | CDE |
| Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | CYHS2602740 | Generic | 2026/11/09 | Not stated by source | CDE |
API registrations
Non-component matches: 5 companies with A status and 19 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 |
|---|---|---|---|---|---|---|
| 苯磺酸美洛加巴林 · No verified English name | Zhejiang Zhu Zi Pharmaceutical Co., Ltd. romanized | Y20260000794 | I | Exact ingredient | 2026/10/16 | CDE |
| 苯磺酸美洛加巴林 · No verified English name | Zhuhai Hai Rui De Pharmaceutical Co., Ltd. romanized | Y20260000652 | I | Exact ingredient | 2026/07/30 | CDE |
| 苯磺酸美洛加巴林 · No verified English name | Zhejiang Che Tou Pharmaceutical Co., Ltd. romanized | Y20260000588 | I | Exact ingredient | 2026/07/22 | CDE |
| 苯磺酸美洛加巴林 · No verified English name | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20260000286 | I | Exact ingredient | 2026/04/22 | CDE |
| 苯磺酸美洛加巴林 · No verified English name | Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | Y20260000129 | I | Exact ingredient | 2026/03/23 | CDE |
| 苯磺酸美洛加巴林 · No verified English name | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | Y20240001488 | I | Exact ingredient | 2026/03/09 | CDE |
| 苯磺酸美洛加巴林 · No verified English name | Topfond Pharmaceutical Co., Ltd. | Y20260000097 | I | Exact ingredient | 2026/02/09 | CDE |
| 苯磺酸美洛加巴林 · No verified English name | Chongqing Sheng Kai Pharmaceutical Co., Ltd. romanized | Y20260000082 | I | Exact ingredient | 2026/02/03 | CDE |
| 苯磺酸美洛加巴林 · No verified English name | Zhejiang Hua Hai Jian Cheng Pharma Co., Ltd. romanized | Y20250001358 | I | Exact ingredient | 2025/12/17 | CDE |
| 苯磺酸美洛加巴林 · No verified English name | Shandong Long Chen Pharma Co., Ltd. romanized | Y20250001242 | I | Exact ingredient | 2025/12/11 | CDE |
| 苯磺酸美洛加巴林 · No verified English name | Han Rui Pharma (Jing Men) Co., Ltd. romanized | Y20250001290 | I | Exact ingredient | 2025/12/09 | CDE |
| 苯磺酸美洛加巴林 · No verified English name | Zhejiang Jing Sheng Pharma Co., Ltd. romanized | Y20250001280 | I | Exact ingredient | 2025/12/08 | CDE |
| 苯磺酸美洛加巴林 · No verified English name | Yan Tai Wan Run Pharma Co., Ltd. romanized | Y20250001223 | I | Exact ingredient | 2025/11/24 | CDE |
| 苯磺酸美洛加巴林 · No verified English name | Sichuan Kelun Pharmaceutical Co., Ltd. | Y20250000830 | I | Exact ingredient | 2025/09/19 | CDE |
| 苯磺酸美洛加巴林 · No verified English name | Anhui Yun Fan Pharma Co., Ltd. romanized | Y20250000204 | I | Exact ingredient | 2025/09/05 | CDE |
| 苯磺酸美洛加巴林 · No verified English name | Shandong Rui Shun Pharma Co., Ltd. romanized | Y20250000700 | I | Exact ingredient | 2025/07/17 | CDE |
| 苯磺酸美洛加巴林 · No verified English name | Hubei Tian Shu Pharma Co., Ltd. romanized | Y20250000629 | I | Exact ingredient | 2025/07/03 | CDE |
| 苯磺酸美洛加巴林 · No verified English name | Fujian Nan Fang Pharmaceutical Co., Ltd. romanized | Y20250000472 | I | Exact ingredient | 2025/05/29 | CDE |
| 苯磺酸美洛加巴林 · No verified English name | Suzhou Zheng Ji Pharma Co., Ltd. romanized | Y20250000388 | I | Exact ingredient | 2025/05/08 | CDE |
| 苯磺酸美洛加巴林 · No verified English name | Sichuan Qing Mu Pharmaceutical Co., Ltd. romanized | Y20240001363 | A | Exact ingredient | 2026/05/06 | CDE |
| 苯磺酸美洛加巴林 · No verified English name | Gansu Hao Tian Pharmaceuticals Technology Co., Ltd. romanized | Y20240000972 | A | Exact ingredient | 2026/06/24 | CDE |
| 苯磺酸美洛加巴林 · No verified English name | Shandong An Hong Pharmaceutical Co., Ltd. romanized | Y20240000736 | A | Exact ingredient | 2026/01/05 | CDE |
| 苯磺酸美洛加巴林 · No verified English name | Sichuan Ren An Pharma Co., Ltd. romanized | Y20240000721 | A | Exact ingredient | 2026/02/25 | CDE |
| 苯磺酸美洛加巴林 · No verified English name | Xuan Cheng Mei Nuo Hua Pharma Co., Ltd. romanized | Y20240000689 | A | Exact ingredient | 2026/03/25 | 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.
-
2026/11/10No longer listed under review
Hainan He Rui Pharmaceutical Co., Ltd. romanized
CYHS2502613
Fact date: 2026/11/10 · Site observation date: 2026/11/10
Accepted: 2025/07/19
not on the CDE under-review list in this snapshot; NMPA published notification delivery for this acceptance number on 2026/11/09; the notification contents are not public and the outcome remains unverified · NMPA source · row 2
NMPA · Table row 2 ↗ View source ↗ -
2026/11/09Notification delivery
Hainan He Rui Pharmaceutical Co., Ltd. romanized
CYHS2502614
Fact date: 2026/11/09 (Publication date) · Publication date: 2026/11/09 · Site observation date: 2026/11/09
Notification delivered; the specific outcome remains to be checked.
View source · Table row 3 ↗ -
2026/11/09Notification delivery
Hainan He Rui Pharmaceutical Co., Ltd. romanized
CYHS2502613
Fact date: 2026/11/09 (Publication date) · Publication date: 2026/11/09 · Site observation date: 2026/11/09
Notification delivered; the specific outcome remains to be checked.
View source · Table row 2 ↗ -
2026/11/09Accepted
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized
CYHS2602742
Fact date: 2026/11/09 · Site observation date: 2026/11/10
View source ↗ -
2026/11/09Accepted
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized
CYHS2602741
Fact date: 2026/11/09 · Site observation date: 2026/11/10
View source ↗ -
2026/11/09Accepted
Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized
CYHS2602740
Fact date: 2026/11/09 · Site observation date: 2026/11/10
View source ↗ -
2026/11/05Trial registration
HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.
CTR20264141
First-publication date: 2026/11/05 · Site observation date: 2026/11/12
Read by this site on 2026/11/12 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/11/05Accepted
Shanghai Fu Dan Fu Hua Pharma Co., Ltd. romanized
CYHS2602710
Fact date: 2026/11/05 · Site observation date: 2026/11/06
View source ↗ -
2026/11/04Trial registration
Anhui Wan Bang Pharmaceuticals Technology Co., Ltd. romanized
CTR20264088
First-publication date: 2026/11/04 · Site observation date: 2026/11/12
Read by this site on 2026/11/12 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/10/30Trial registration
Zhejiang Wei Kang Pharmaceutical Co., Ltd. romanized
CTR20264107
First-publication date: 2026/10/30 · Site observation date: 2026/11/12
Read by this site on 2026/11/12 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/10/30Trial registration
Yan Tai Wan Run Pharma Co., Ltd. romanized
CTR20264081
First-publication date: 2026/10/30 · Site observation date: 2026/11/12
Read by this site on 2026/11/12 as “Ongoing”
Registry classification: Unmapped source value · Registry phase: Other · BE
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/10/30Accepted
Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized
CYHS2602663
Fact date: 2026/10/30 · Site observation date: 2026/10/31
View source ↗ -
2026/10/23Trial registration
Shandong Cheng Chuang Lan Hai Pharmaceuticals Technology Co., Ltd. romanized
CTR20264030
First-publication date: 2026/10/23 · Site observation date: 2026/11/12
Read by this site on 2026/11/12 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/10/14Trial registration
Shanghai Shyndec Pharmaceutical Co., Ltd.
CTR20263763
First-publication date: 2026/10/14 · Site observation date: 2026/11/12
Read by this site on 2026/11/12 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/10/14Accepted
Fujian Dong Rui Pharmaceutical Co., Ltd. romanized
CYHS2602540
Fact date: 2026/10/14 · Site observation date: 2026/10/22
View source ↗ -
2026/10/14Accepted
Fujian Dong Rui Pharmaceutical Co., Ltd. romanized
CYHS2602539
Fact date: 2026/10/14 · Site observation date: 2026/10/22
View source ↗ -
2026/10/12Trial registration
Hebei Long Hai Pharma Co., Ltd. romanized
CTR20263798
First-publication date: 2026/10/12 · Site observation date: 2026/11/12
Read by this site on 2026/11/12 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/10/12Trial registration
Shanghai Shyndec Pharmaceutical Co., Ltd.
CTR20263762
First-publication date: 2026/10/12 · Site observation date: 2026/11/12
Read by this site on 2026/11/12 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/10/09Trial registration
Jiangsu En Hua Pharma Co., Ltd. romanized
CTR20263809
First-publication date: 2026/10/09 · Site observation date: 2026/11/12
Read by this site on 2026/11/12 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/09/22Trial registration
Jiangsu Deyuan Pharmaceutical Co.,Ltd.
CTR20263688
First-publication date: 2026/09/22 · Site observation date: 2026/11/12
Read by this site on 2026/11/12 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/09/20Trial registration
Jiangsu Vanguard Pharmaceutical Co., Ltd.
CTR20263634
First-publication date: 2026/09/20 · Site observation date: 2026/11/12
Read by this site on 2026/11/12 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/09/18Trial registration
Yangtze River Pharmaceutical Group Co., Ltd
CTR20263610
First-publication date: 2026/09/18 · Site observation date: 2026/11/12
Read by this site on 2026/11/12 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/09/16Accepted
Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
CYHS2602305
Fact date: 2026/09/16 · Site observation date: 2026/10/21
View source ↗ -
2026/09/16Accepted
Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
CYHS2602304
Fact date: 2026/09/16 · Site observation date: 2026/10/21
View source ↗ -
2026/09/07Trial registration
Hua Zhong Pharma Co., Ltd. romanized
CTR20263473
First-publication date: 2026/09/07 · Site observation date: 2026/11/12
Read by this site on 2026/11/12 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/09/03Accepted
Beijing Foyou Pharma CO.,LTD
CYHS2602195
Fact date: 2026/09/03 · Site observation date: 2026/10/22
View source ↗ -
2026/09/03Accepted
Beijing Foyou Pharma CO.,LTD
CYHS2602194
Fact date: 2026/09/03 · Site observation date: 2026/10/22
View source ↗ -
2026/08/26Trial registration
Shanghai Shyndec Pharmaceutical Co., Ltd.
CTR20263278
First-publication date: 2026/08/26 · Site observation date: 2026/11/12
Read by this site on 2026/11/12 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
View source ↗ -
2026/08/24Accepted
Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.
CYHS2602105
Fact date: 2026/08/24 · Site observation date: 2026/10/22
View source ↗ -
2026/08/24Accepted
Ningbo Menovo Tiankang Pharmaceutical Co., Ltd.
CYHS2602104
Fact date: 2026/08/24 · Site observation date: 2026/10/22
View source ↗ -
2026/08/19Trial registration
Jiangsu Vanguard Pharmaceutical Co., Ltd.
CTR20263122
First-publication date: 2026/08/19 · Site observation date: 2026/11/12
Read by this site on 2026/11/12 as “Ongoing”
Registry classification: Bioequivalence / bioavailability study · Registry phase: Other · See source
Historical registration backfill; not a current-period new event.
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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