Monthly
US$200
Billed every month
Sign in to subscribePolymyxin B sulfate for Injection
As of 13 November 2026, for Polymyxin B sulfate for Injection, 6 applications are listed as under review at China's CDE; 2 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 14 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: No longer listed under review: 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 holders14View records ↓
Under-review filings6View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers17View records ↓
API companies with A status10View records ↓
Chemical-drug catalogue
Loaded records: 14 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 14 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 |
|---|---|---|---|---|---|---|
| Fujian Sheng Fu Kang Pharma Co., Ltd. romanized | Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20266022 | 2026/09/15 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan Shuang Cheng Pharma Co., Ltd. romanized | Hainan Shuang Cheng Pharma Co., Ltd. romanized | 国药准字H20265679 | 2026/08/18 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hefei Hua Wei Pharma Co., Ltd. romanized | Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized | 国药准字H20265327 | 2026/07/21 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized | Guangdong Sunho Pharmaceutical Co., Ltd. | 国药准字H20264928 | 2026/06/23 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Xu Lie Bio Technology Co., Ltd. romanized | Bo Rui Pharmaceutical (Suzhou) Co., Ltd. romanized | 国药准字H20264579 | 2026/06/03 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Yao Su (Shanghai) Medical Technology Co., Ltd. romanized | Shandong Hao Rui En Pharmaceutical Co., Ltd. romanized | 国药准字H20264436 | 2026/05/19 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hainan He Rui Pharmaceutical Co., Ltd. romanized | Hainan He Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20264123 | 2026/04/21 | 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H20263777 | 2026/03/31 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hunan Ai Wei Ge Lin Pharmaceuticals Technology Co., Ltd. romanized | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. | 国药准字H20263682 | 2026/03/25 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Health Yuan Pharma Group Co., Ltd. romanized | Health Yuan Hai Bin Pharma Co., Ltd. romanized | 国药准字H20263370 | 2026/02/10 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized | Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized | 国药准字H20263089 | 2026/01/14 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Sichuan Shang Shan Liu Jing Pharmaceuticals Technology Co., Ltd. romanized | Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized | 国药准字H20255210 | 2025/08/26 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Li Tai Er Pharma Co., Ltd. romanized | Jiangsu Li Tai Er Pharma Co., Ltd. romanized | 国药准字H20255208 | 2025/08/26 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Name not romanized | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized | 国药准字H20254318 | 2025/05/27 | 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: 17 distinct approval numbers and 17 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Fujian Sheng Fu Kang Pharma Co., Ltd. romanized | 国药准字H20266022 | See source | Category B | XJ01XBD198B001010104791 | NHSA |
| Hainan He Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20264123 | See source | Category B | XJ01XBD198B001010105815 | NHSA |
| Qi Lu Pharmaceutical (Hainan) Co., Ltd. romanized | 国药准字H20263777 | See source | Category B | XJ01XBD198B001010105847 | NHSA |
| Xellia Pharmaceuticals ApS | 国药准字HJ20250039 | See source | Category B | XJ01XBD198B001010179515 | NHSA |
| Jiangsu Li Tai Er Pharma Co., Ltd. romanized | 国药准字H20255208 | See source | Category B | XJ01XBD198B001010182291 | NHSA |
| Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized | 国药准字H20263089 | See source | Category B | XJ01XBD198B001010182719 | NHSA |
| Health Yuan Pharma Group Co., Ltd. romanized | 国药准字H20263370 | See source | Category B | XJ01XBD198B001010183037 | NHSA |
| Yao Su (Shanghai) Medical Technology Co., Ltd. romanized | 国药准字H20264436 | See source | Category B | XJ01XBD198B001010184081 | NHSA |
| Hunan Ai Wei Ge Lin Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263682 | See source | Category B | XJ01XBD198B001010184441 | NHSA |
| Name not romanized | 国药准字H20254318 | See source | Category B | XJ01XBD198B001010184532 | NHSA |
| Chengdu Ya Tu Bio Technology Co., Ltd. romanized | 国药准字H20264537 | See source | Category B | XJ01XBD198B001010184540 | NHSA |
| Guangzhou Ai Qi Xi Xin Yao Research Co., Ltd. romanized | 国药准字H20264928 | See source | Category B | XJ01XBD198B001010184971 | NHSA |
| Guangdong Wan Tai Yuan Ke Chuang Pharma Co., Ltd. romanized | 国药准字H20265753 | See source | Category B | XJ01XBD198B001010185190 | NHSA |
| Shandong Xu Lie Bio Technology Co., Ltd. romanized | 国药准字H20264579 | See source | Category B | XJ01XBD198B001010185565 | NHSA |
| Hainan Brilliant Pharmaceutical Co., Ltd. | 国药准字H20254404 | See source | Category B | XJ01XBD198B001010205791 | NHSA |
| Hainan He Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20264123 | See source | Category B | XJ01XBD198B001010205815 | NHSA |
| Xellia Pharmaceuticals ApS | 国药准字HJ20250039 | See source | Category B | XJ01XBD198B001010279515 | NHSA |
| Health Yuan Pharma Group Co., Ltd. romanized | 国药准字H20263370 | See source | Category B | XJ01XBD198B001010283037 | NHSA |
| Yao Su (Shanghai) Medical Technology Co., Ltd. romanized | 国药准字H20264436 | See source | Category B | XJ01XBD198B001010284081 | NHSA |
| Shandong Xu Lie Bio Technology Co., Ltd. romanized | 国药准字H20264579 | See source | Category B | XJ01XBD198B001010285565 | NHSA |
| Shanghai Shang Yao Di Yi Sheng Hua Pharma Co., Ltd. romanized | 国药准字H31022631 | See source | Category B | XJ01XBD198B014010100651 | NHSA |
| Hainan Shuang Cheng Pharma Co., Ltd. romanized | 国药准字H20265679 | See source | Category B | XJ01XBD198B001010105814 | 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: 6 filings and 6 distinct first applicants.
Generic 5 · Supplement 1
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Hu Zhou Ya Se Pharmaceutical Co., Ltd. romanized | CYHS2601064 | Generic | 2026/05/09 | Not stated by source | CDE |
| Hebei Sheng Xue Da Cheng Pharmaceutical Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD | CYHS2600966 | Generic | 2026/04/25 | Not stated by source | CDE |
| Yan Tai Lu Yin Pharma Co., Ltd. romanized | CYHS2502410 | Generic | 2025/07/08 | Not stated by source | CDE |
| Shanghai Shang Yao Di Yi Sheng Hua Pharma Co., Ltd. romanized | CYHB2550332 | Supplement | 2025/09/28 | Not stated by source | CDE |
| Guo Yao Group Guo Rui Pharma Co., Ltd. romanized | CYHS2502963 | Generic | 2025/08/14 | Not stated by source | CDE |
| Hebei Rui Jian Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized | CYHS2502821 | Generic | 2025/08/05 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 2 filings and 2 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Hu Zhou Ya Se Pharmaceutical Co., Ltd. romanized | CYHS2601064 | Generic | 2026/05/09 | Not stated by source | CDE |
| Hebei Sheng Xue Da Cheng Pharmaceutical Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD | CYHS2600966 | Generic | 2026/04/25 | Not stated by source | CDE |
API registrations
Non-component matches: 10 companies with A status and 3 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 |
|---|---|---|---|---|---|---|
| 硫酸多黏菌素B · No verified English name | Gan Zhou Rui Zhi Biopharmaceuticals Co., Ltd. romanized | Y20250001047 | I | Exact ingredient | 2025/10/15 | CDE |
| 硫酸多黏菌素B · No verified English name | Hebei Sheng Xue Da Cheng Pharmaceutical Co., Ltd. romanized | Y20240000964 | A | Exact ingredient | 2026/04/14 | CDE |
| 硫酸多黏菌素B · No verified English name | Shandong Lu Xi Pharma Co., Ltd. romanized | Y20240000914 | A | Exact ingredient | 2026/09/11 | CDE |
| 硫酸多黏菌素B · No verified English name | Fujian Sheng Fu Kang Pharma Co., Ltd. romanized | Y20240000823 | A | Exact ingredient | 2026/07/01 | CDE |
| 硫酸多黏菌素B · No verified English name | Sichuan Nuo Yi Sheng Pharma Co., Ltd. romanized | Y20240000179 | A | Exact ingredient | 2025/12/31 | CDE |
| 硫酸多黏菌素B · No verified English name | Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized | Y20230000987 | A | Exact ingredient | 2026/05/20 | CDE |
| 硫酸多黏菌素B · No verified English name | Hua Bei Pharmaceutical Hua Sheng Co., Ltd. romanized | Y20230000780 | A | Exact ingredient | 2025/06/10 | CDE |
| 硫酸多黏菌素B · No verified English name | Li Zhu Group Fuzhou Fu Xing Pharmaceuticals Co., Ltd. romanized | Y20230000739 | A | Exact ingredient | 2026/07/28 | CDE |
| 硫酸多黏菌素B · No verified English name | Sichuan Ren An Pharma Co., Ltd. romanized | Y20230000683 | A | Exact ingredient | 2025/03/21 | CDE |
| 硫酸多黏菌素B · No verified English name | Hangzhou Zhong Mei Hua Dong Pharmaceutical Jiang Dong Co., Ltd. romanized | Y20220000257 | A | Exact ingredient | 2024/08/05 | CDE |
| 硫酸多黏菌素B · No verified English name | Xellia Pharmaceuticals ApS | Y20190009041 | A | Exact ingredient | 2024/11/29 | CDE |
| 硫酸多黏菌素B · No verified English name | Xellia Pharmaceuticals ApS | Y20190009030 | A | Exact ingredient | 2024/11/29 | CDE |
| 硫酸多黏菌素B（供局部用） · No verified English name | Xellia Pharmaceuticals ApS | Y20190000206 | I | Exact ingredient | 2019/04/12 | CDE |
| 硫酸多黏菌素B（供注射用） · No verified English name | Xellia Pharmaceuticals ApS | Y20190000204 | I | Exact ingredient | 2019/04/12 | CDE |
| 硫酸多黏菌素B · No verified English name | Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized | Y20170000899 | A | Exact ingredient | 2023/03/24 | 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.
-
2026/11/10No longer listed under review
Fu An Pharma Group Yan Tai Zhi Chu Pharma Co., Ltd. romanized
CYHS2501237
Fact date: 2026/11/10 · Site observation date: 2026/11/10
Accepted: 2025/04/01
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/11/04No longer listed under review
Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanized
CYHS2500724
Fact date: 2026/11/04 · Site observation date: 2026/11/04
Accepted: 2025/02/13
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/10/24No longer listed under review
Anhui Pioneer Pharmaceutical Co., Ltd
CYHS2500852
Fact date: 2026/10/24 · Site observation date: 2026/10/24
Accepted: 2025/02/26
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/10/24No longer listed under review
Gui Lin Nan Yao Co., Ltd. romanized; Suzhou Erye Pharmaceutical Co., Ltd
CYHS2500394
Fact date: 2026/10/24 · Site observation date: 2026/10/24
Accepted: 2025/01/22
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
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.
Free follow
Follow changes to Polymyxin B sulfate for Injection
Up to 3 drugs per email address, in one weekly digest. Starts after email confirmation; unsubscribe at any time.
Subscriptions
Next-day facts and deliverable timelines
- One email the next day when new facts are collected for your followed products.
- Export the complete loaded event timeline for each followed product as CSV.
- Add up to 4 additional recipients, each confirmed by email.
- Increase your follow limit from 3 to 10 products.
Quarterly
US$540
Billed every three months
US$180 per month
Sign in to subscribeYearly
US$1,920
Billed every year
US$160 per month
Sign in to subscribeNeed more than 10 followed products or more than 5 recipients? Contact us.
Separate one-time purchase
US Orange Book × China records comparison
Full table and CSV export for 12 months from payment, with monthly data updates. No automatic renewal.
Subscriptions and comparison-table access are purchased separately. Neither includes the other.
Billed by Creem, our merchant of record · Terms · Refund policy