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Sign in to subscribeIsavuconazonium Sulfate for Injection
As of 13 November 2026, for Isavuconazonium Sulfate for Injection, 15 applications are listed as under review at China's CDE; 4 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 31 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 2 applicationsAccepted: 4 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 holders31View records ↓
Under-review filings15View records ↓
This year’s generic filers4View records ↓
NHSA approval numbers32View records ↓
API companies with A status9View records ↓
Chemical-drug catalogue
Loaded records: 31 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 31 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 |
|---|---|---|---|---|---|---|
| Hainan Ling Kang Pharmaceutical Co., Ltd. romanized | Hainan Ling Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20266031 | 2026/09/22 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Haikou Shi Pharmaceutical Factory Co., Ltd. romanized | Haikou Shi Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20266028 | 2026/09/22 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shang Yao Dong Ying (Jiangsu) Pharma Co., Ltd. romanized | Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized | 国药准字H20265930 | 2026/09/15 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Gui Lin Nan Yao Co., Ltd. romanized | Suzhou Erye Pharmaceutical Co., Ltd | 国药准字H20265952 | 2026/09/15 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20265586 | 2026/08/04 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Brilliant Pharmaceutical Co., Ltd. | Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H20265593 | 2026/08/04 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| HAINAN HUALON PHARMACEUTICAL CO.,LTD | HAINAN HUALON PHARMACEUTICAL CO.,LTD | 国药准字H20265106 | 2026/07/08 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hubei Wu Shi Pharmaceuticals Research Institute Co., Ltd. romanized | Hubei Wu Shi Pharma Co., Ltd. romanized | 国药准字H20264965 | 2026/06/23 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20264498 | 2026/05/27 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H20264419 | 2026/05/19 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | Chongqing Bo Teng Pharma Co., Ltd. romanized | 国药准字H20264373 | 2026/05/19 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized | Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized | 国药准字H20264302 | 2026/05/12 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H20264222 | 2026/05/07 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Henan Xin Tai Pharma Co., Ltd. romanized | Henan Xin Tai Pharma Co., Ltd. romanized | 国药准字H20264226 | 2026/05/07 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20264032 | 2026/04/14 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Tong Yong San Yang Pharma Co., Ltd. romanized | Hainan Tong Yong San Yang Pharma Co., Ltd. romanized | 国药准字H20263524 | 2026/03/10 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized | Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20263500 | 2026/03/03 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized | Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized | 国药准字H20256404 | 2025/12/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized | Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized | 国药准字H20256477 | 2025/12/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | 国药准字H20255224 | 2025/08/26 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Qidu Pharmaceutical Co., Ltd. | Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H20255036 | 2025/07/29 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Li Nuo Pharmaceutical Co., Ltd. romanized | Shanxi De Yuan Tang Pharma Co., Ltd. romanized | 国药准字H20254537 | 2025/06/17 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| NORTH CHINA PHARMACEUTICAL COMPANY.LTD | NORTH CHINA PHARMACEUTICAL COMPANY.LTD | 国药准字H20254299 | 2025/05/27 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | Shanxi Pu De Pharma Co., Ltd. romanized | 国药准字H20254347 | 2025/05/27 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Chongqing Xi Wei Pharmaceuticals Technology Co., Ltd. romanized | Chongqing Bo Teng Pharma Co., Ltd. romanized | 国药准字H20254057 | 2025/04/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Qilu Pharmaceutical (Hainan) Co., Ltd | Qilu Pharmaceutical (Hainan) Co., Ltd | 国药准字H20253662 | 2025/03/18 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized | Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized | 国药准字H20243631 | 2024/04/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hua Run Shuang He Pharma Co., Ltd. romanized | Hua Run Shuang He Pharma Co., Ltd. romanized | 国药准字H20266339 | 2026/10/20 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Pharmaceutical Formulations Co., Ltd. romanized | Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 国药准字H20265392 | 2026/07/28 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20256410 | 2025/12/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Jin Rui Bao Pharmaceuticals Technology Co., Ltd. romanized | Chongqing Bo Teng Pharma Co., Ltd. romanized | 国药准字H20256483 | 2025/12/30 | 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: 32 distinct approval numbers and 32 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | 国药准字H20255224 | See source | Category B | XJ02ACA370B001010101012 | NHSA |
| Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized | 国药准字H20243631 | See source | Category B | XJ02ACA370B001010101425 | NHSA |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20265586 | See source | Category B | XJ02ACA370B001010101495 | NHSA |
| Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized | 国药准字H20264302 | See source | Category B | XJ02ACA370B001010101938 | NHSA |
| Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized | 国药准字H20256477 | See source | Category B | XJ02ACA370B001010102066 | NHSA |
| Sichuan Mei Da Kang Hua Kang Pharma Co., Ltd. romanized | 国药准字H20264419 | See source | Category B | XJ02ACA370B001010102087 | NHSA |
| Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 国药准字H20265392 | See source | Category B | XJ02ACA370B001010102297 | NHSA |
| NORTH CHINA PHARMACEUTICAL COMPANY.LTD | 国药准字H20254299 | See source | Category B | XJ02ACA370B001010102690 | NHSA |
| Henan Xin Tai Pharma Co., Ltd. romanized | 国药准字H20264226 | See source | Category B | XJ02ACA370B001010103091 | NHSA |
| Nei Menggu Bai Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20263500 | See source | Category B | XJ02ACA370B001010103889 | NHSA |
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H20255036 | See source | Category B | XJ02ACA370B001010104145 | NHSA |
| SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED | 国药准字H20254347 | See source | Category B | XJ02ACA370B001010104187 | NHSA |
| Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized | 国药准字H20256213 | See source | Category B | XJ02ACA370B001010104384 | NHSA |
| Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | 国药准字H20264222 | See source | Category B | XJ02ACA370B001010104520 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20264498 | See source | Category B | XJ02ACA370B001010104647 | NHSA |
| Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 国药准字H20264032 | See source | Category B | XJ02ACA370B001010104948 | NHSA |
| HAINAN HUALON PHARMACEUTICAL CO.,LTD | 国药准字H20265106 | See source | Category B | XJ02ACA370B001010105781 | NHSA |
| Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H20265593 | See source | Category B | XJ02ACA370B001010105791 | NHSA |
| Hainan Ling Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20266031 | See source | Category B | XJ02ACA370B001010105793 | NHSA |
| Hainan Tong Yong San Yang Pharma Co., Ltd. romanized | 国药准字H20263524 | See source | Category B | XJ02ACA370B001010105821 | NHSA |
| Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H20253662 | See source | Category B | XJ02ACA370B001010105847 | NHSA |
| Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized | 国药准字H20256127 | See source | Category B | XJ02ACA370B001010109554 | NHSA |
| Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 国药准字H20264373 | See source | Category B | XJ02ACA370B001010181251 | NHSA |
| Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized | 国药准字H20255440 | See source | Category B | XJ02ACA370B001010182719 | NHSA |
| Shandong Li Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20254537 | See source | Category B | XJ02ACA370B001010183093 | NHSA |
| Pfizer Australia Pty Ltd | 国药准字HJ20220054 | See source | Category B | XJ02ACA370B001010183103 | NHSA |
| Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20256410 | See source | Category B | XJ02ACA370B001010183135 | NHSA |
| Hainan Jin Rui Bao Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20256483 | See source | Category B | XJ02ACA370B001010184246 | NHSA |
| Hubei Wu Shi Pharmaceuticals Research Institute Co., Ltd. romanized | 国药准字H20264965 | See source | Category B | XJ02ACA370B001010184568 | NHSA |
| Chongqing Xi Wei Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254057 | See source | Category B | XJ02ACA370B001010184682 | NHSA |
| Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized | 国药准字H20256404 | See source | Category B | XJ02ACA370B001010184827 | NHSA |
| Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized | 国药准字H20243631 | See source | Category B | XJ02ACA370B001010201425 | NHSA |
| Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20265586 | See source | Category B | XJ02ACA370B001010201495 | NHSA |
| Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized | 国药准字H20264302 | See source | Category B | XJ02ACA370B001010201938 | NHSA |
| Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized | 国药准字H20256477 | See source | Category B | XJ02ACA370B001010202066 | NHSA |
| Henan Xin Tai Pharma Co., Ltd. romanized | 国药准字H20264226 | See source | Category B | XJ02ACA370B001010203091 | NHSA |
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H20255036 | See source | Category B | XJ02ACA370B001010204145 | NHSA |
| Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized | 国药准字H20256213 | See source | Category B | XJ02ACA370B001010204384 | NHSA |
| Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H20265593 | See source | Category B | XJ02ACA370B001010205791 | NHSA |
| Hainan Tong Yong San Yang Pharma Co., Ltd. romanized | 国药准字H20263524 | See source | Category B | XJ02ACA370B001010205821 | NHSA |
| Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized | 国药准字H20256127 | See source | Category B | XJ02ACA370B001010209554 | NHSA |
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H20255036 | See source | Category B | XJ02ACA370B001010304145 | NHSA |
| Haikou Shi Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20266028 | See source | Category B | XJ02ACA370B001010105758 | NHSA |
| Haikou Shi Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20266028 | See source | Category B | XJ02ACA370B001010205758 | 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: 15 filings and 14 distinct first applicants.
Supplement 3 · Generic 11 · Import re-registration 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Qilu Pharmaceutical (Hainan) Co., Ltd; Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized | CYHB2601641 | Supplement | 2026/08/26 | Not stated by source | CDE |
| Shandong Lukang Pharmaceutical Co.,Ltd.; Chengdu Tong De Pharma Co., Ltd. romanized | CYHS2601214 | Generic | 2026/06/01 | Not stated by source | CDE |
| Shandong Yi Kang Pharma Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanized | CYHS2602216 | Generic | 2026/09/07 | Not stated by source | CDE |
| Tianjin Hong Ri Pharma Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanized | CYHS2503292 | Generic | 2025/09/05 | Not stated by source | CDE |
| Jiangsu De Li Bio Co., Ltd. romanized; Jiangsu Jin Si Li Pharma Co., Ltd. romanized | CYHS2600027 | Generic | 2026/01/05 | Not stated by source | CDE |
| Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized | CYHB2601779 | Supplement | 2026/09/21 | Not stated by source | CDE |
| Pfizer Australia Pty Ltd; Simtra US LLC; Pfizer Investment CO. Ltd. | JYHZ2600217 | Import re-registration | 2026/09/08 | Not stated by source | CDE |
| Ru Yuan Dong Yang Guang Pharma Co., Ltd. romanized | CYHS2600412 | Generic | 2026/02/09 | Not stated by source | CDE |
| Pfizer Australia Pty Ltd; Simtra US LLC; Patheon Italia SPA | JYHB2500549 | Supplement | 2025/10/21 | Not stated by source | CDE |
| Beijing Hai Bu Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized | CYHS2503169 | Generic | 2025/08/29 | Not stated by source | CDE |
| Hubei Mei Lin Pharma Co., Ltd. romanized | CYHS2503091 | Generic | 2025/08/23 | Not stated by source | CDE |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | CYHS2502915 | Generic | 2025/08/11 | Not stated by source | CDE |
| HUNAN WARRANT PHARMACEUTICAL CO.,LTD | CYHS2502811 | Generic | 2025/08/04 | Not stated by source | CDE |
| Mu Dan Jiang You Bo Pharma Co., Ltd. romanized | CYHS2502101 | Generic | 2025/06/12 | Not stated by source | CDE |
| Hubei Kai An Chen Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized | CYHS2403824 | Generic | 2024/11/08 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 4 filings and 4 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Shandong Lukang Pharmaceutical Co.,Ltd.; Chengdu Tong De Pharma Co., Ltd. romanized | CYHS2601214 | Generic | 2026/06/01 | Not stated by source | CDE |
| Shandong Yi Kang Pharma Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanized | CYHS2602216 | Generic | 2026/09/07 | Not stated by source | CDE |
| Jiangsu De Li Bio Co., Ltd. romanized; Jiangsu Jin Si Li Pharma Co., Ltd. romanized | CYHS2600027 | Generic | 2026/01/05 | Not stated by source | CDE |
| Ru Yuan Dong Yang Guang Pharma Co., Ltd. romanized | CYHS2600412 | Generic | 2026/02/09 | Not stated by source | CDE |
API registrations
Non-component matches: 9 companies with A status and 6 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 |
|---|---|---|---|---|---|---|
| 硫酸艾沙康唑 · No verified English name | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | Y20260000693 | I | Exact ingredient | 2026/08/24 | CDE |
| 硫酸艾沙康唑 · No verified English name | Shandong Yi Kang Pharma Co., Ltd. romanized | Y20250001110 | I | Exact ingredient | 2025/11/18 | CDE |
| 硫酸艾沙康唑 · No verified English name | Hunan Hua Na Da Pharmaceutical Factory Shou Xing Drug Co., Ltd. romanized | Y20250000478 | I | Exact ingredient | 2025/07/09 | CDE |
| 硫酸艾沙康唑 · No verified English name | Ha Yao Group San Jing Ming Shui Pharma Co., Ltd. romanized | Y20250000303 | I | Exact ingredient | 2025/04/22 | CDE |
| 硫酸艾沙康唑 · No verified English name | Fu An Pharma Group Chongqing Bo Sheng Pharmaceutical Co., Ltd. romanized | Y20240001226 | A | Exact ingredient | 2026/08/26 | CDE |
| 硫酸艾沙康唑 · No verified English name | Hunan Sai Long Pharma Co., Ltd. romanized | Y20240001110 | I | Exact ingredient | 2024/11/06 | CDE |
| 硫酸艾沙康唑 · No verified English name | Shijiazhuang Long Ze Pharmaceutical Co., Ltd. romanized | Y20240001116 | A | Exact ingredient | 2026/05/07 | CDE |
| 硫酸艾沙康唑 · No verified English name | Guangdong Xian Qiang Pharma Co., Ltd. romanized | Y20240000732 | I | Exact ingredient | 2024/07/24 | CDE |
| 硫酸艾沙康唑 · No verified English name | Shang Yao Kang Li (Changzhou) Pharma Co., Ltd. romanized | Y20230001128 | A | Exact ingredient | 2025/12/29 | CDE |
| 硫酸艾沙康唑 · No verified English name | Shanghai Di Sai Nuo Chemical Pharmaceutical Co., Ltd. romanized | Y20230001386 | A | Exact ingredient | 2026/04/11 | CDE |
| 硫酸艾沙康唑 · No verified English name | Jiangxi Guo Yao Co., Ltd. romanized | Y20230001378 | A | Exact ingredient | 2026/06/02 | CDE |
| 硫酸艾沙康唑 · No verified English name | Sichuan Yi Nuo Da Bo Pharmaceuticals Technology Co., Ltd. romanized | Y20230000865 | A | Exact ingredient | 2026/06/16 | CDE |
| 硫酸艾沙康唑 · No verified English name | Sichuan Kelun Pharmaceutical Co., Ltd. | Y20230000518 | A | Exact ingredient | 2026/10/14 | CDE |
| 硫酸艾沙康唑 · No verified English name | Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized | Y20230000572 | A | Exact ingredient | 2025/03/14 | CDE |
| 硫酸艾沙康唑 · No verified English name | Nanjing Hai Run Pharmaceuticals Co., Ltd. romanized | Y20210001068 | A | Exact ingredient | 2026/02/09 | 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.
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.
-
2026/11/03Marketing application approved
Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized
CYHS2500956 · 国药准字H20266460
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 36 ↗ -
2026/10/20Marketing application approved
Hua Run Shuang He Pharma Co., Ltd. romanized
CYHS2404575 · 国药准字H20266339
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 15 ↗ -
2026/09/21Accepted
Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized
CYHB2601779
Fact date: 2026/09/21 · Site observation date: 2026/10/22
View source ↗ -
2026/09/08Accepted
Pfizer Australia Pty Ltd; Simtra US LLC; Pfizer Investment CO. Ltd.
JYHZ2600217
Fact date: 2026/09/08 · Site observation date: 2026/10/22
View source ↗ -
2026/09/07Accepted
Shandong Yi Kang Pharma Co., Ltd. romanized; Jiangsu Hai An Pharma Co., Ltd. romanized
CYHS2602216
Fact date: 2026/09/07 · Site observation date: 2026/10/21
View source ↗ -
2026/08/26Accepted
Qilu Pharmaceutical (Hainan) Co., Ltd; Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized
CYHB2601641
Fact date: 2026/08/26 · Site observation date: 2026/10/21
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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