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Sign in to subscribeAs of 13 November 2026, for Baricitinib Tablets, 32 applications are listed as under review at China's CDE; 15 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 9 holders.
Companies, stages and changes, with each record available on this page.
Listed in the US FDA Orange Book as OLUMIANT (NDA 207924, ELI LILLY AND CO).
Last 90 days: Marketing application approved: 2 applicationsAccepted: 4 applications
Current coverage may be incomplete
The brand names come from the US FDA Orange Book and describe US listing records for this active ingredient. They do not indicate that products under these brand names are approved or sold in China, or that Chinese applicants are affiliated with US holders.
Orange Book source export date: 2026/11/06. Version: 2026-11-06.
Showing 1 of 1 distinct brand names.
A brand with different source forms or statuses can appear on multiple rows and in both groups. Distinct brand names are counted once globally, with a limit of five.
Verified official English dosage form: Tablets. Listings are grouped by the source dosage form and route; records without a clear correspondence are listed in the other group. Grouping does not establish product equivalence.
| Brand name | Applicant (source text) | Application number | Dosage form (source text) | Route (source text) | Marketing status (source text) | Approval date |
|---|---|---|---|---|---|---|
| OLUMIANT | ELI LILLY AND CO | NDA 207924 · Product no. 001 | TABLET | ORAL | HUMAN PRESCRIPTION DRUG | 2018/05/31 |
| OLUMIANT | ELI LILLY AND CO | NDA 207924 · Product no. 002 | TABLET | ORAL | HUMAN PRESCRIPTION DRUG | 2019/10/08 |
| OLUMIANT | ELI LILLY AND CO | NDA 207924 · Product no. 003 | TABLET | ORAL | HUMAN PRESCRIPTION DRUG | 2022/05/10 |
No listings in this group among the displayed brand names.
Same-form/route listings come first, followed by other forms/routes. Within each group, source prescription/OTC listings precede discontinued listings; unknown statuses are last. Each status bucket is ordered by earliest approval date, ascending: pre-1982 records first, missing dates last; ties by brand name, application number and product number. The first five distinct brands in this order are selected globally. All retained source facts for those brands are shown in their own groups; a brand spanning both groups counts once.
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.
Loaded records: 9 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 9 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 |
|---|---|---|---|---|---|---|
| Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized | 国药准字H20264889 | 2026/06/17 | 2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized | 国药准字H20264888 | 2026/06/17 | 4mg | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20264245 | 2026/05/07 | 2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized | 国药准字H20256432 | 2025/12/30 | 4mg | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | Hangzhou Zhu Yang Xin Pharma Co., Ltd. romanized | 国药准字H20256433 | 2025/12/30 | 2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20256318 | 2025/12/16 | 2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20256317 | 2025/12/16 | 4mg | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20256060 | 2025/11/25 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | 国药准字H20255895 | 2025/11/12 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hangzhou Minsheng Pharmaceutical Co., Ltd | Hangzhou Minsheng Pharmaceutical Co., Ltd | 国药准字H20255470 | 2025/09/09 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing Li Bo Wei Pharmaceutical Co., Ltd. romanized | Nanjing You Ke Pharmaceutical Co., Ltd. romanized | 国药准字H20234188 | 2023/09/28 | 2mg | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Wan Hui Shuang He Pharma Co., Ltd. romanized | Hua Run Shuang He Pharma Co., Ltd. romanized | 国药准字H20266244 | 2026/10/13 | 2mg | 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.
Loaded records: 13 distinct approval numbers and 9 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized | 国药准字H20264888 | 4mg | Category B | XL04AAB233A001010100475 | NHSA |
| Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20256317 | 4mg | Category B | XL04AAB233A001010101729 | NHSA |
| Hangzhou Minsheng Pharmaceutical Co., Ltd | 国药准字H20255470 | See source | Category B | XL04AAB233A001010104494 | NHSA |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H20256433 | 2mg | Category B | XL04AAB233A001010104960 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20264245 | 2mg | Category B | XL04AAB233A001010106632 | NHSA |
| Eli Lilly Nederland B.V. | 国药准字HJ20190039 | See source | Category B | XL04AAB233A001010178403 | NHSA |
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | 国药准字H20255895 | See source | Category B | XL04AAB233A001010180537 | NHSA |
| Nanjing Li Bo Wei Pharmaceutical Co., Ltd. romanized | 国药准字H20234188 | 2mg | Category B | XL04AAB233A001010180542 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20256060 | See source | Category B | XL04AAB233A001010183034 | NHSA |
| Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20256317 | 4mg | Category B | XL04AAB233A001010201729 | NHSA |
| Hangzhou Minsheng Pharmaceutical Co., Ltd | 国药准字H20255470 | See source | Category B | XL04AAB233A001010204494 | NHSA |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H20256433 | 2mg | Category B | XL04AAB233A001010204960 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20264245 | 2mg | Category B | XL04AAB233A001010206632 | NHSA |
| Eli Lilly Nederland B.V. | 国药准字HJ20190039 | See source | Category B | XL04AAB233A001010278403 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20256060 | See source | Category B | XL04AAB233A001010283034 | NHSA |
| Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20256317 | 4mg | Category B | XL04AAB233A001010301729 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20264245 | 2mg | Category B | XL04AAB233A001010306632 | NHSA |
| Eli Lilly Nederland B.V. | 国药准字HJ20190039 | See source | Category B | XL04AAB233A001010378403 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20256060 | See source | Category B | XL04AAB233A001010383034 | NHSA |
| Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20256317 | 4mg | Category B | XL04AAB233A001010401729 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20264245 | 2mg | Category B | XL04AAB233A001010406632 | NHSA |
| Eli Lilly Nederland B.V. | 国药准字HJ20190039 | See source | Category B | XL04AAB233A001010478403 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20256060 | See source | Category B | XL04AAB233A001010483034 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20264245 | 2mg | Category B | XL04AAB233A001010506632 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20256060 | See source | Category B | XL04AAB233A001010583034 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20264245 | 2mg | Category B | XL04AAB233A001010606632 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20256060 | See source | Category B | XL04AAB233A001010683034 | NHSA |
| Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | 国药准字H20256060 | See source | Category B | XL04AAB233A001010783034 | NHSA |
| Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized | 国药准字H20264889 | 2mg | Category B | XL04AAB233A001020100475 | NHSA |
| Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20256318 | 2mg | Category B | XL04AAB233A001020101729 | NHSA |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H20256432 | 4mg | Category B | XL04AAB233A001020104960 | NHSA |
| Eli Lilly Nederland B.V. | 国药准字HJ20215001 | See source | Category B | XL04AAB233A001020178403 | NHSA |
| Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20256318 | 2mg | Category B | XL04AAB233A001020201729 | NHSA |
| Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 国药准字H20256432 | 4mg | Category B | XL04AAB233A001020204960 | NHSA |
| Eli Lilly Nederland B.V. | 国药准字HJ20215001 | See source | Category B | XL04AAB233A001020278403 | NHSA |
| Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20256318 | 2mg | Category B | XL04AAB233A001020301729 | NHSA |
| Eli Lilly Nederland B.V. | 国药准字HJ20215001 | See source | Category B | XL04AAB233A001020378403 | NHSA |
| Fu Xing Wan Bang (Jiangsu) Pharmaceuticals Group Co., Ltd. romanized | 国药准字H20256318 | 2mg | Category B | XL04AAB233A001020401729 | NHSA |
| Eli Lilly Nederland B.V. | 国药准字HJ20215001 | See source | Category B | XL04AAB233A001020478403 | 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.
Loaded records: 32 filings and 23 distinct first applicants.
Generic 30 · Import 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | CYHS2502940 | Generic | 2025/08/13 | Not stated by source | CDE |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | CYHS2502939 | Generic | 2025/08/13 | Not stated by source | CDE |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | CYHS2502558 | Generic | 2025/07/16 | Not stated by source | CDE |
| Hubei Min Kang Pharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2602396 | Generic | 2026/09/23 | Not stated by source | CDE |
| Hubei Min Kang Pharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2602395 | Generic | 2026/09/23 | Not stated by source | CDE |
| NANJING ZENKOM PHARMACEUTICAL CO.,LTD. | CYHS2504312 | Generic | 2025/12/19 | Not stated by source | CDE |
| Jiangsu Shen Hua Pharma Co., Ltd. romanized | CYHS2601782 | Generic | 2026/07/24 | Not stated by source | CDE |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | CYHS2602588 | Generic | 2026/10/21 | Not stated by source | CDE |
| Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized | CYHS2602386 | Generic | 2026/09/22 | Not stated by source | CDE |
| Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized | CYHS2602021 | Generic | 2026/08/14 | Not stated by source | CDE |
| Anhui Bei Ke Biopharmaceutical Co., Ltd. romanized | CYHS2601730 | Generic | 2026/07/20 | Not stated by source | CDE |
| Anhui Bei Ke Biopharmaceutical Co., Ltd. romanized | CYHS2601729 | Generic | 2026/07/20 | Not stated by source | CDE |
| CISEN PHARMACEUTICAL CO., LTD. | CYHS2601701 | Generic | 2026/07/16 | Not stated by source | CDE |
| CISEN PHARMACEUTICAL CO., LTD. | CYHS2601700 | Generic | 2026/07/16 | Not stated by source | CDE |
| Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | CYHS2601466 | Generic | 2026/06/23 | Not stated by source | CDE |
| Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Dong Wu Pharmaceutical (Shandong) Co., Ltd. romanized | CYHS2601102 | Generic | 2026/05/13 | Not stated by source | CDE |
| Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Dong Wu Pharmaceutical (Shandong) Co., Ltd. romanized | CYHS2601101 | Generic | 2026/05/13 | Not stated by source | CDE |
| Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CYHS2600935 | Generic | 2026/04/23 | Not stated by source | CDE |
| Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | CYHS2600723 | Generic | 2026/03/26 | Not stated by source | CDE |
| Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | CYHS2600722 | Generic | 2026/03/26 | Not stated by source | CDE |
| MSN LABORATORIES PRIVATE LIMITED | JYHS2600005 | Import | 2026/03/02 | Not stated by source | CDE |
| MSN LABORATORIES PRIVATE LIMITED | JYHS2600004 | Import | 2026/03/02 | Not stated by source | CDE |
| Jiangxi Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized | CYHS2600566 | Generic | 2026/02/27 | Not stated by source | CDE |
| Zhejiang Dong Ya Pharma Co., Ltd. romanized | CYHS2600397 | Generic | 2026/02/06 | Not stated by source | CDE |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | CYHS2600139 | Generic | 2026/01/10 | Not stated by source | CDE |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | CYHS2600138 | Generic | 2026/01/10 | Not stated by source | CDE |
| Beijing Foyou Pharma CO.,LTD | CYHS2600012 | Generic | 2026/01/05 | Not stated by source | CDE |
| Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | CYHS2504339 | Generic | 2025/12/22 | Not stated by source | CDE |
| Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized | CYHS2504338 | Generic | 2025/12/22 | Not stated by source | CDE |
| Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | CYHS2503843 | Generic | 2025/10/31 | Not stated by source | CDE |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | CYHS2502962 | Generic | 2025/08/13 | Not stated by source | CDE |
| Hai Hua Sheng Ming (Xiamen) Technology Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized | CYHS2502477 | Generic | 2025/07/11 | Not stated by source | CDE |
Loaded records: 21 filings and 15 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Hubei Min Kang Pharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2602396 | Generic | 2026/09/23 | Not stated by source | CDE |
| Hubei Min Kang Pharmaceutical Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2602395 | Generic | 2026/09/23 | Not stated by source | CDE |
| Jiangsu Shen Hua Pharma Co., Ltd. romanized | CYHS2601782 | Generic | 2026/07/24 | Not stated by source | CDE |
| Shandong Liang Fu Pharmaceutical Co., Ltd. romanized | CYHS2602588 | Generic | 2026/10/21 | Not stated by source | CDE |
| Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized | CYHS2602386 | Generic | 2026/09/22 | Not stated by source | CDE |
| Shanghai Shang Yao Zhong Xi Pharmaceutical Co., Ltd. romanized | CYHS2602021 | Generic | 2026/08/14 | Not stated by source | CDE |
| Anhui Bei Ke Biopharmaceutical Co., Ltd. romanized | CYHS2601730 | Generic | 2026/07/20 | Not stated by source | CDE |
| Anhui Bei Ke Biopharmaceutical Co., Ltd. romanized | CYHS2601729 | Generic | 2026/07/20 | Not stated by source | CDE |
| CISEN PHARMACEUTICAL CO., LTD. | CYHS2601701 | Generic | 2026/07/16 | Not stated by source | CDE |
| CISEN PHARMACEUTICAL CO., LTD. | CYHS2601700 | Generic | 2026/07/16 | Not stated by source | CDE |
| Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | CYHS2601466 | Generic | 2026/06/23 | Not stated by source | CDE |
| Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Dong Wu Pharmaceutical (Shandong) Co., Ltd. romanized | CYHS2601102 | Generic | 2026/05/13 | Not stated by source | CDE |
| Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Dong Wu Pharmaceutical (Shandong) Co., Ltd. romanized | CYHS2601101 | Generic | 2026/05/13 | Not stated by source | CDE |
| Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CYHS2600935 | Generic | 2026/04/23 | Not stated by source | CDE |
| Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | CYHS2600723 | Generic | 2026/03/26 | Not stated by source | CDE |
| Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | CYHS2600722 | Generic | 2026/03/26 | Not stated by source | CDE |
| Jiangxi Di Sai Nuo Pharmaceuticals Group Co., Ltd. romanized | CYHS2600566 | Generic | 2026/02/27 | Not stated by source | CDE |
| Zhejiang Dong Ya Pharma Co., Ltd. romanized | CYHS2600397 | Generic | 2026/02/06 | Not stated by source | CDE |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | CYHS2600139 | Generic | 2026/01/10 | Not stated by source | CDE |
| Ningbo Menovo Tiankang Pharmaceutical Co., Ltd. | CYHS2600138 | Generic | 2026/01/10 | Not stated by source | CDE |
| Beijing Foyou Pharma CO.,LTD | CYHS2600012 | Generic | 2026/01/05 | Not stated by source | CDE |
Non-component matches: 7 companies with A status and 12 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 |
|---|---|---|---|---|---|---|
| 巴瑞替尼 · No verified English name | Ru Yuan Dong Yang Guang Pharma Co., Ltd. romanized | Y20260000673 | I | Exact ingredient | 2026/09/01 | CDE |
| 巴瑞替尼 · No verified English name | Wu Yi Ci Hang Pharma Co., Ltd. romanized | Y20260000638 | I | Exact ingredient | 2026/08/04 | CDE |
| 巴瑞替尼 · No verified English name | Shandong Ji Kun Biopharmaceutical Co., Ltd. romanized | Y20260000592 | I | Exact ingredient | 2026/07/14 | CDE |
| 巴瑞替尼 · No verified English name | Liaoning Xing Hai Pharmaceutical Co., Ltd. romanized | Y20260000400 | I | Exact ingredient | 2026/05/15 | CDE |
| 巴瑞替尼 · No verified English name | Shandong Dao He Pharma Co., Ltd. romanized | Y20260000212 | I | Exact ingredient | 2026/05/11 | CDE |
| 巴瑞替尼 · No verified English name | Shanghai Zhong Xi San Wei Pharma Co., Ltd. romanized | Y20250001467 | I | Exact ingredient | 2026/01/15 | CDE |
| 巴瑞替尼 · No verified English name | Hubei Mei Lin Pharma Co., Ltd. romanized | Y20250001378 | I | Exact ingredient | 2025/12/29 | CDE |
| 巴瑞替尼 · No verified English name | Anhui Bei Ke Pharmaceutical Co., Ltd. romanized | Y20250001127 | I | Exact ingredient | 2025/12/26 | CDE |
| 巴瑞替尼 · No verified English name | Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | Y20250001134 | I | Exact ingredient | 2025/11/11 | CDE |
| 巴瑞替尼 · No verified English name | Yi Chang Tian Rui Biopharmaceuticals Co., Ltd. romanized | Y20250000826 | I | Exact ingredient | 2025/08/19 | CDE |
| 巴瑞替尼 · No verified English name | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | Y20250000801 | I | Exact ingredient | 2025/08/11 | CDE |
| 巴瑞替尼 · No verified English name | Zhejiang Hua Hai Jian Cheng Pharma Co., Ltd. romanized | Y20250000399 | I | Exact ingredient | 2025/04/30 | CDE |
| 巴瑞替尼 · No verified English name | Fujian Nan Fang Pharmaceutical Co., Ltd. romanized | Y20230000885 | A | Exact ingredient | 2026/03/26 | CDE |
| 巴瑞替尼 · No verified English name | Xu Zhou Wan Bang Jin Qiao Pharmaceutical Co., Ltd. romanized | Y20240000287 | A | Exact ingredient | 2025/12/25 | CDE |
| 巴瑞替尼 · No verified English name | Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | Y20240000293 | A | Exact ingredient | 2026/02/13 | CDE |
| 巴瑞替尼 · No verified English name | Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | Y20240000146 | A | Exact ingredient | 2026/07/16 | CDE |
| 巴瑞替尼 · No verified English name | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized | Y20230000965 | A | Exact ingredient | 2026/05/20 | CDE |
| 巴瑞替尼 · No verified English name | Natco Pharma Limited | Y20230000557 | A | Exact ingredient | 2025/12/17 | CDE |
| 巴瑞替尼 · No verified English name | Nanjing Li Bo Wei Pharmaceutical Co., Ltd. romanized | Y20210000460 | A | Exact ingredient | 2024/05/16 | 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.
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.
CYHS2602588
Fact date: 2026/10/21 · Site observation date: 2026/10/22
View source ↗CYHS2501647 · 国药准字H20266382
Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03
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 61 ↗CYHS2501646 · 国药准字H20266381
Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03
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 60 ↗CYHS2602396
Fact date: 2026/09/23 · Site observation date: 2026/10/21
View source ↗CYHS2602395
Fact date: 2026/09/23 · Site observation date: 2026/10/21
View source ↗CYHS2602386
Fact date: 2026/09/22 · Site observation date: 2026/10/22
View source ↗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.
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.
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.
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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