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Sign in to subscribeAzithromycin for Suspension
As of 14 November 2026, for Azithromycin for Suspension, 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 25 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 1 applicationNo longer listed under review: 3 applicationsSupplement 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 holders25View records ↓
Under-review filings6View records ↓
This year’s generic filers2View records ↓
NHSA approval numbers48View records ↓
API companies with A status34View records ↓
Chemical-drug catalogue
Loaded records: 25 holders; 9 in the quality-and-efficacy consistency-evaluation category, and 13 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 |
|---|---|---|---|---|---|---|
| Hunan Jiudian Pharmaceutical Co., Ltd | Hunan Jiudian Pharmaceutical Co., Ltd | 国药准字H20266048 | 2026/09/22 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Zhejiang Zhong Tong Pharma Co., Ltd. romanized | Zhejiang Zhong Tong Pharma Co., Ltd. romanized | 国药准字H20263577 | 2026/03/10 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20263438 | 2026/02/25 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shanghai Shyndec Pharmaceutical Co., Ltd. | Shanghai Shyndec Pharmaceutical Co., Ltd. | 国药准字H20041281 | 2025/06/24 | 0.1g | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Henan Bi Fu Pharmaceutical Co., Ltd. romanized | Henan Bi Fu Pharmaceutical Co., Ltd. romanized | 国药准字H20249812 | 2024/12/25 | See source | Not stated by source | CDE |
| Hainan Si Da Pharmaceutical Co., Ltd. romanized | Hainan Sai Li Ke Pharma Co., Ltd. romanized | 国药准字H20249741 | 2024/12/17 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Di Sha Pharma Group Co., Ltd. romanized | Di Sha Pharma Group Co., Ltd. romanized | 国药准字H20249662 | 2024/12/01 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized | Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized | 国药准字H20094126 | 2024/11/29 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Changchun Hai Yue Pharma Co., Ltd. romanized | Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | 2024/09/03 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | 国药准字H20057591 | 2024/09/02 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Sichuan Bai Li Pharma Co., Ltd. romanized | Sichuan Bai Li Pharma Co., Ltd. romanized | 国药准字H20244232 | 2024/06/28 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Rui Yang Pharmaceutical Co., Ltd. romanized | Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20244181 | 2024/06/28 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20234224 | 2023/09/28 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 国药准字H20234182 | 2023/09/19 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Ji Chuan Pharma Group Co., Ltd. romanized | Ji Chuan Pharma Group Co., Ltd. romanized | 国药准字H20233759 | 2023/06/21 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jilin Si Huan Pharmaceutical Co., Ltd. romanized | Jilin Si Huan Pharmaceutical Co., Ltd. romanized | 国药准字H20233566 | 2023/05/19 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized | Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized | 国药准字H20093669 | 2023/03/22 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H20237002 | 2023/01/18 | 100mg/5mL | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H20237007 | 2023/01/18 | 200mg/5mL | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H10980217 | 2023/01/18 | 0.1g | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | Zhejiang Pu Li Pharma Co., Ltd. romanized | 国药准字H20057604 | 2023/01/18 | 0.1g | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Suzhou Dong Rui Pharmaceutical Co., Ltd. romanized | Suzhou Dong Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20058153 | 2022/12/26 | 0.1g | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Xian Li Jun Pharmaceutical Co., Ltd. romanized | Xian Li Jun Pharmaceutical Co., Ltd. romanized | 国药准字H20083443 | 2022/10/27 | See source | Drug that passed quality-and-efficacy consistency evaluation | CDE |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223641 | 2022/08/30 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Name not romanized | Hui Rui Pharmaceutical Co., Ltd. romanized | 国药准字H10960112 | 1995/08/21 | See source | Other drug | CDE |
| Pliva Croatia Ltd. | Pliva Croatia Ltd. | H20160584 | 1994/03/13 | 100mg/5ml | Imported originator drug | CDE |
| Pliva Croatia Ltd. | Pliva Croatia Ltd. | H20160585;H20160614 | 1994/03/13 | 200mg/5ml | Imported originator drug | CDE |
| Zhejiang Kang De Pharma Group Co., Ltd. romanized | Zhejiang Kang De Pharma Group Co., Ltd. romanized | 国药准字H20066930 | 2026/11/02 | 0.1g | Drug that passed quality-and-efficacy consistency evaluation | 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: 48 distinct approval numbers and 39 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Shou Er Pharma (Beijing) Co., Ltd. romanized | 国药准字H20084530 | See source | Category B | XJ01FAA051X006010100138 | NHSA |
| Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20263438 | See source | Category B | XJ01FAA051X006010100151 | NHSA |
| Guo Yao Group Shan Tou Jin Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20059064 | 0.1g | Category B | XJ01FAA051X006010100480 | NHSA |
| Shanghai Shyndec Pharmaceutical Co., Ltd. | 国药准字H20041281 | See source | Category B | XJ01FAA051X006010100785 | NHSA |
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20073900 | See source | Category B | XJ01FAA051X006010101161 | NHSA |
| Hui Rui Pharmaceutical Technology Co., Ltd. romanized | 国药准字H10960112 | See source | Category B | XJ01FAA051X006010101187 | NHSA |
| Ji Chuan Pharma Group Co., Ltd. romanized | 国药准字H20233759 | See source | Category B | XJ01FAA051X006010101453 | NHSA |
| Nan Tong Jiu He Pharma Co., Ltd. romanized | 国药准字H20065329 | 0.1g | Category B | XJ01FAA051X006010101623 | NHSA |
| Suzhou Dong Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20058153 | 0.1g | Category B | XJ01FAA051X006010101650 | NHSA |
| Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | 国药准字H20057591 | See source | Category B | XJ01FAA051X006010101997 | NHSA |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | 国药准字H20234182 | See source | Category B | XJ01FAA051X006010102000 | NHSA |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20234224 | See source | Category B | XJ01FAA051X006010102013 | NHSA |
| Sichuan Bai Li Pharma Co., Ltd. romanized | 国药准字H20244232 | See source | Category B | XJ01FAA051X006010102120 | NHSA |
| Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 国药准字H20083473 | See source | Category B | XJ01FAA051X006010102297 | NHSA |
| Xian Li Jun Pharmaceutical Co., Ltd. romanized | 国药准字H20083443 | See source | Category B | XJ01FAA051X006010102503 | NHSA |
| Kui Hua Pharma Group (Heng Shui) De Fei Er Co., Ltd. romanized | 国药准字H20063830 | See source | Category B | XJ01FAA051X006010102621 | NHSA |
| Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | 国药准字H20073728 | See source | Category B | XJ01FAA051X006010102753 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223641 | See source | Category B | XJ01FAA051X006010102763 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H10980217 | 0.1g | Category B | XJ01FAA051X006010102770 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006010103307 | NHSA |
| Jilin Si Huan Pharmaceutical Co., Ltd. romanized | 国药准字H20233566 | See source | Category B | XJ01FAA051X006010103492 | NHSA |
| Haerbin Er Tong Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20103048 | 0.1g | Category B | XJ01FAA051X006010103628 | NHSA |
| Heilongjiang Nuo Jie Pharmaceutical Co., Ltd. romanized | 国药准字H20057332 | 0.1g | Category B | XJ01FAA051X006010103706 | NHSA |
| Shandong Lv Yin Pharma Co., Ltd. romanized | 国药准字H20059971 | 0.1g | Category B | XJ01FAA051X006010104140 | NHSA |
| Rui Yang Pharmaceutical Co., Ltd. romanized | 国药准字H20244181 | See source | Category B | XJ01FAA051X006010104152 | NHSA |
| Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized | 国药准字H20094126 | 0.1g | Category B | XJ01FAA051X006010104203 | NHSA |
| Zhejiang Ai Nuo Bio Pharma Co., Ltd. romanized | 国药准字H20083832 | 0.1g | Category B | XJ01FAA051X006010104617 | NHSA |
| Zhejiang Kang De Pharma Group Co., Ltd. romanized | 国药准字H20066930 | 0.1g | Category B | XJ01FAA051X006010104669 | NHSA |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20057207 | 0.1g | Category B | XJ01FAA051X006010104914 | NHSA |
| Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized | 国药准字H20093669 | See source | Category B | XJ01FAA051X006010105283 | NHSA |
| Jiangxi Hong Xing Pharma Co., Ltd. romanized | 国药准字H20064805 | 0.1g | Category B | XJ01FAA051X006010105295 | NHSA |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 国药准字H20057604 | 0.1g | Category B | XJ01FAA051X006010105801 | NHSA |
| Hainan Sai Li Ke Pharma Co., Ltd. romanized | 国药准字H20249741 | See source | Category B | XJ01FAA051X006010105816 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20074238 | 0.125g | Category B | XJ01FAA051X006010105826 | NHSA |
| Pliva Croatia Ltd. | H20160585 | 200mg/5ml | Category B | XJ01FAA051X006010179335 | NHSA |
| Henan Bi Fu Pharmaceutical Co., Ltd. romanized | 国药准字H20249812 | See source | Category B | XJ01FAA051X006010183004 | NHSA |
| Zhejiang Zhong Tong Pharma Co., Ltd. romanized | 国药准字H20263577 | See source | Category B | XJ01FAA051X006010184243 | NHSA |
| Da Jia Wei Kang Biopharmaceutical Co., Ltd. romanized | 国药准字H20264545 | See source | Category B | XJ01FAA051X006010184377 | NHSA |
| Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20263438 | See source | Category B | XJ01FAA051X006010200151 | NHSA |
| Guo Yao Group Shan Tou Jin Shi Pharmaceutical Co., Ltd. romanized | 国药准字H20059064 | 0.1g | Category B | XJ01FAA051X006010200480 | NHSA |
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20073900 | See source | Category B | XJ01FAA051X006010201161 | NHSA |
| Liaoning Xin Gao Pharmaceutical Co., Ltd. romanized | 国药准字H20057713 | 0.1g | Category B | XJ01FAA051X006010201288 | NHSA |
| Nan Tong Jiu He Pharma Co., Ltd. romanized | 国药准字H20065329 | 0.1g | Category B | XJ01FAA051X006010201623 | NHSA |
| Suzhou Dong Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20058153 | 0.1g | Category B | XJ01FAA051X006010201650 | NHSA |
| Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | 国药准字H20057591 | See source | Category B | XJ01FAA051X006010201997 | NHSA |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | 国药准字H20234182 | See source | Category B | XJ01FAA051X006010202000 | NHSA |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20234224 | See source | Category B | XJ01FAA051X006010202013 | NHSA |
| Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 国药准字H20083473 | See source | Category B | XJ01FAA051X006010202297 | NHSA |
| Xian Li Jun Pharmaceutical Co., Ltd. romanized | 国药准字H20083443 | See source | Category B | XJ01FAA051X006010202503 | NHSA |
| Kui Hua Pharma Group (Heng Shui) De Fei Er Co., Ltd. romanized | 国药准字H20063830 | See source | Category B | XJ01FAA051X006010202621 | NHSA |
| Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | 国药准字H20073728 | See source | Category B | XJ01FAA051X006010202753 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223641 | See source | Category B | XJ01FAA051X006010202763 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H10980217 | 0.1g | Category B | XJ01FAA051X006010202770 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006010203307 | NHSA |
| Jilin Si Huan Pharmaceutical Co., Ltd. romanized | 国药准字H20233566 | See source | Category B | XJ01FAA051X006010203492 | NHSA |
| Haerbin Er Tong Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20103048 | 0.1g | Category B | XJ01FAA051X006010203628 | NHSA |
| Heilongjiang Nuo Jie Pharmaceutical Co., Ltd. romanized | 国药准字H20057332 | 0.1g | Category B | XJ01FAA051X006010203706 | NHSA |
| Shandong Lv Yin Pharma Co., Ltd. romanized | 国药准字H20059971 | 0.1g | Category B | XJ01FAA051X006010204140 | NHSA |
| Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized | 国药准字H20094126 | 0.1g | Category B | XJ01FAA051X006010204203 | NHSA |
| Zhejiang Ai Nuo Bio Pharma Co., Ltd. romanized | 国药准字H20083832 | 0.1g | Category B | XJ01FAA051X006010204617 | NHSA |
| Zhejiang Kang De Pharma Group Co., Ltd. romanized | 国药准字H20066930 | 0.1g | Category B | XJ01FAA051X006010204669 | NHSA |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20057207 | 0.1g | Category B | XJ01FAA051X006010204914 | NHSA |
| Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized | 国药准字H20093669 | See source | Category B | XJ01FAA051X006010205283 | NHSA |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 国药准字H20057604 | 0.1g | Category B | XJ01FAA051X006010205801 | NHSA |
| Hainan Sai Li Ke Pharma Co., Ltd. romanized | 国药准字H20249741 | See source | Category B | XJ01FAA051X006010205816 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20074238 | 0.125g | Category B | XJ01FAA051X006010205826 | NHSA |
| Henan Bi Fu Pharmaceutical Co., Ltd. romanized | 国药准字H20249812 | See source | Category B | XJ01FAA051X006010283004 | NHSA |
| Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20263438 | See source | Category B | XJ01FAA051X006010300151 | NHSA |
| Liaoning Xin Gao Pharmaceutical Co., Ltd. romanized | 国药准字H20057713 | 0.1g | Category B | XJ01FAA051X006010301288 | NHSA |
| Nan Tong Jiu He Pharma Co., Ltd. romanized | 国药准字H20065329 | 0.1g | Category B | XJ01FAA051X006010301623 | NHSA |
| Suzhou Dong Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20058153 | 0.1g | Category B | XJ01FAA051X006010301650 | NHSA |
| Yi Chang Ren Fu Pharma Co., Ltd. romanized | 国药准字H20234182 | See source | Category B | XJ01FAA051X006010302000 | NHSA |
| Chengdu Brilliant Pharmaceutical Co., Ltd. | 国药准字H20234224 | See source | Category B | XJ01FAA051X006010302013 | NHSA |
| Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 国药准字H20083473 | See source | Category B | XJ01FAA051X006010302297 | NHSA |
| Kui Hua Pharma Group (Heng Shui) De Fei Er Co., Ltd. romanized | 国药准字H20063830 | See source | Category B | XJ01FAA051X006010302621 | NHSA |
| Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | 国药准字H20073728 | See source | Category B | XJ01FAA051X006010302753 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223641 | See source | Category B | XJ01FAA051X006010302763 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H10980217 | 0.1g | Category B | XJ01FAA051X006010302770 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006010303307 | NHSA |
| Jilin Si Huan Pharmaceutical Co., Ltd. romanized | 国药准字H20233566 | See source | Category B | XJ01FAA051X006010303492 | NHSA |
| Haerbin Er Tong Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20103048 | 0.1g | Category B | XJ01FAA051X006010303628 | NHSA |
| Heilongjiang Nuo Jie Pharmaceutical Co., Ltd. romanized | 国药准字H20057332 | 0.1g | Category B | XJ01FAA051X006010303706 | NHSA |
| Shandong Lv Yin Pharma Co., Ltd. romanized | 国药准字H20059971 | 0.1g | Category B | XJ01FAA051X006010304140 | NHSA |
| Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized | 国药准字H20094126 | 0.1g | Category B | XJ01FAA051X006010304203 | NHSA |
| Zhejiang Kang De Pharma Group Co., Ltd. romanized | 国药准字H20066930 | 0.1g | Category B | XJ01FAA051X006010304669 | NHSA |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20057207 | 0.1g | Category B | XJ01FAA051X006010304914 | NHSA |
| Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized | 国药准字H20093669 | See source | Category B | XJ01FAA051X006010305283 | NHSA |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 国药准字H20057604 | 0.1g | Category B | XJ01FAA051X006010305801 | NHSA |
| Hainan Sai Li Ke Pharma Co., Ltd. romanized | 国药准字H20249741 | See source | Category B | XJ01FAA051X006010305816 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20074238 | 0.125g | Category B | XJ01FAA051X006010305826 | NHSA |
| Henan Bi Fu Pharmaceutical Co., Ltd. romanized | 国药准字H20249812 | See source | Category B | XJ01FAA051X006010383004 | NHSA |
| Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20263438 | See source | Category B | XJ01FAA051X006010400151 | NHSA |
| Liaoning Xin Gao Pharmaceutical Co., Ltd. romanized | 国药准字H20057713 | 0.1g | Category B | XJ01FAA051X006010401288 | NHSA |
| Nan Tong Jiu He Pharma Co., Ltd. romanized | 国药准字H20065329 | 0.1g | Category B | XJ01FAA051X006010401623 | NHSA |
| Suzhou Dong Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20058153 | 0.1g | Category B | XJ01FAA051X006010401650 | NHSA |
| Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 国药准字H20083473 | See source | Category B | XJ01FAA051X006010402297 | NHSA |
| Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | 国药准字H20073728 | See source | Category B | XJ01FAA051X006010402753 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223641 | See source | Category B | XJ01FAA051X006010402763 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H10980217 | 0.1g | Category B | XJ01FAA051X006010402770 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006010403307 | NHSA |
| Haerbin Er Tong Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20103048 | 0.1g | Category B | XJ01FAA051X006010403628 | NHSA |
| Shandong Lv Yin Pharma Co., Ltd. romanized | 国药准字H20059971 | 0.1g | Category B | XJ01FAA051X006010404140 | NHSA |
| Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized | 国药准字H20094126 | 0.1g | Category B | XJ01FAA051X006010404203 | NHSA |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 国药准字H20057604 | 0.1g | Category B | XJ01FAA051X006010405801 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20074238 | 0.125g | Category B | XJ01FAA051X006010405826 | NHSA |
| Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20263438 | See source | Category B | XJ01FAA051X006010500151 | NHSA |
| Nan Tong Jiu He Pharma Co., Ltd. romanized | 国药准字H20065329 | 0.1g | Category B | XJ01FAA051X006010501623 | NHSA |
| Suzhou Dong Rui Pharmaceutical Co., Ltd. romanized | 国药准字H20058153 | 0.1g | Category B | XJ01FAA051X006010501650 | NHSA |
| Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 国药准字H20083473 | See source | Category B | XJ01FAA051X006010502297 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223641 | See source | Category B | XJ01FAA051X006010502763 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H10980217 | 0.1g | Category B | XJ01FAA051X006010502770 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006010503307 | NHSA |
| Haerbin Er Tong Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20103048 | 0.1g | Category B | XJ01FAA051X006010503628 | NHSA |
| Shandong Lv Yin Pharma Co., Ltd. romanized | 国药准字H20059971 | 0.1g | Category B | XJ01FAA051X006010504140 | NHSA |
| Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized | 国药准字H20094126 | 0.1g | Category B | XJ01FAA051X006010504203 | NHSA |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 国药准字H20057604 | 0.1g | Category B | XJ01FAA051X006010505801 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20074238 | 0.125g | Category B | XJ01FAA051X006010505826 | NHSA |
| Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20263438 | See source | Category B | XJ01FAA051X006010600151 | NHSA |
| Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 国药准字H20083473 | See source | Category B | XJ01FAA051X006010602297 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223641 | See source | Category B | XJ01FAA051X006010602763 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H10980217 | 0.1g | Category B | XJ01FAA051X006010602770 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006010603307 | NHSA |
| Haerbin Er Tong Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20103048 | 0.1g | Category B | XJ01FAA051X006010603628 | NHSA |
| Shandong Lv Yin Pharma Co., Ltd. romanized | 国药准字H20059971 | 0.1g | Category B | XJ01FAA051X006010604140 | NHSA |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 国药准字H20057604 | 0.1g | Category B | XJ01FAA051X006010605801 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20074238 | 0.125g | Category B | XJ01FAA051X006010605826 | NHSA |
| Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 国药准字H20263438 | See source | Category B | XJ01FAA051X006010700151 | NHSA |
| Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 国药准字H20083473 | See source | Category B | XJ01FAA051X006010702297 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223641 | See source | Category B | XJ01FAA051X006010702763 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H10980217 | 0.1g | Category B | XJ01FAA051X006010702770 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006010703307 | NHSA |
| Haerbin Er Tong Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20103048 | 0.1g | Category B | XJ01FAA051X006010703628 | NHSA |
| Shandong Lv Yin Pharma Co., Ltd. romanized | 国药准字H20059971 | 0.1g | Category B | XJ01FAA051X006010704140 | NHSA |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 国药准字H20057604 | 0.1g | Category B | XJ01FAA051X006010705801 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20074238 | 0.125g | Category B | XJ01FAA051X006010705826 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223641 | See source | Category B | XJ01FAA051X006010802763 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006010803307 | NHSA |
| Haerbin Er Tong Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20103048 | 0.1g | Category B | XJ01FAA051X006010803628 | NHSA |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 国药准字H20057604 | 0.1g | Category B | XJ01FAA051X006010805801 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223641 | See source | Category B | XJ01FAA051X006010902763 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006010903307 | NHSA |
| Haerbin Er Tong Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20103048 | 0.1g | Category B | XJ01FAA051X006010903628 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223641 | See source | Category B | XJ01FAA051X006011002763 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006011003307 | NHSA |
| Haerbin Er Tong Pharmaceutical Factory Co., Ltd. romanized | 国药准字H20103048 | 0.1g | Category B | XJ01FAA051X006011003628 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223641 | See source | Category B | XJ01FAA051X006011102763 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006011103307 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223641 | See source | Category B | XJ01FAA051X006011202763 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006011203307 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223641 | See source | Category B | XJ01FAA051X006011302763 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006011303307 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223641 | See source | Category B | XJ01FAA051X006011402763 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006011403307 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223641 | See source | Category B | XJ01FAA051X006011502763 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006011503307 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223641 | See source | Category B | XJ01FAA051X006011602763 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006011603307 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223641 | See source | Category B | XJ01FAA051X006011702763 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006011703307 | NHSA |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20223641 | See source | Category B | XJ01FAA051X006011802763 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006011803307 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006011903307 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006012003307 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006012103307 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006012203307 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006012303307 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006012403307 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006012503307 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006012603307 | NHSA |
| Changchun Hai Yue Pharma Co., Ltd. romanized | 国药准字H20244817 | See source | Category B | XJ01FAA051X006012703307 | NHSA |
| Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 国药准字H20073900 | See source | Category B | XJ01FAA051X006020101161 | NHSA |
| Hui Rui Pharmaceutical Technology Co., Ltd. romanized | 国药准字H10960112 | See source | Category B | XJ01FAA051X006020101187 | NHSA |
| Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | 国药准字H20057591 | See source | Category B | XJ01FAA051X006020101997 | NHSA |
| Kui Hua Pharma Group (Heng Shui) De Fei Er Co., Ltd. romanized | 国药准字H20063830 | See source | Category B | XJ01FAA051X006020102621 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20046654 | See source | Category B | XJ01FAA051X006020102770 | NHSA |
| Heilongjiang Nuo Jie Pharmaceutical Co., Ltd. romanized | 国药准字H20057332 | 0.1g | Category B | XJ01FAA051X006020103706 | NHSA |
| Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized | 国药准字H20094126 | 0.1g | Category B | XJ01FAA051X006020104203 | NHSA |
| Zhejiang Ai Nuo Bio Pharma Co., Ltd. romanized | 国药准字H20083832 | 0.1g | Category B | XJ01FAA051X006020104617 | NHSA |
| Zhejiang Kang De Pharma Group Co., Ltd. romanized | 国药准字H20066930 | 0.1g | Category B | XJ01FAA051X006020104669 | NHSA |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20057207 | 0.1g | Category B | XJ01FAA051X006020104914 | NHSA |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 国药准字H20237007 | 200mg/5mL | Category B | XJ01FAA051X006020105801 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20057649 | 0.1g | Category B | XJ01FAA051X006020105826 | NHSA |
| Heilongjiang Nuo Jie Pharmaceutical Co., Ltd. romanized | 国药准字H20057332 | 0.1g | Category B | XJ01FAA051X006020203706 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20057649 | 0.1g | Category B | XJ01FAA051X006020205826 | NHSA |
| Heilongjiang Nuo Jie Pharmaceutical Co., Ltd. romanized | 国药准字H20057332 | 0.1g | Category B | XJ01FAA051X006020303706 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20057649 | 0.1g | Category B | XJ01FAA051X006020305826 | NHSA |
| Heilongjiang Nuo Jie Pharmaceutical Co., Ltd. romanized | 国药准字H20057332 | 0.1g | Category B | XJ01FAA051X006020403706 | NHSA |
| Zhejiang Kang De Pharma Group Co., Ltd. romanized | 国药准字H20066930 | 0.1g | Category B | XJ01FAA051X006020404669 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20057649 | 0.1g | Category B | XJ01FAA051X006020405826 | NHSA |
| Heilongjiang Nuo Jie Pharmaceutical Co., Ltd. romanized | 国药准字H20057332 | 0.1g | Category B | XJ01FAA051X006020503706 | NHSA |
| Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized | 国药准字H20094126 | 0.1g | Category B | XJ01FAA051X006020504203 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20057649 | 0.1g | Category B | XJ01FAA051X006020505826 | NHSA |
| Heilongjiang Nuo Jie Pharmaceutical Co., Ltd. romanized | 国药准字H20057332 | 0.1g | Category B | XJ01FAA051X006020603706 | NHSA |
| Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized | 国药准字H20094126 | 0.1g | Category B | XJ01FAA051X006020604203 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20057649 | 0.1g | Category B | XJ01FAA051X006020605826 | NHSA |
| Heilongjiang Nuo Jie Pharmaceutical Co., Ltd. romanized | 国药准字H20057332 | 0.1g | Category B | XJ01FAA051X006020703706 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20057649 | 0.1g | Category B | XJ01FAA051X006020705826 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20057649 | 0.1g | Category B | XJ01FAA051X006020805826 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20057649 | 0.1g | Category B | XJ01FAA051X006020905826 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20057649 | 0.1g | Category B | XJ01FAA051X006021005826 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20057649 | 0.1g | Category B | XJ01FAA051X006021105826 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20057649 | 0.1g | Category B | XJ01FAA051X006021205826 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20057649 | 0.1g | Category B | XJ01FAA051X006021305826 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H20046655 | See source | Category B | XJ01FAA051X006030102770 | NHSA |
| Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized | 国药准字H20094126 | 0.1g | Category B | XJ01FAA051X006030104203 | NHSA |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20057207 | 0.1g | Category B | XJ01FAA051X006030104914 | NHSA |
| Jiangxi Gan Nan Hai Xin Pharma Co., Ltd. romanized | 国药准字H20093669 | See source | Category B | XJ01FAA051X006030105283 | NHSA |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 国药准字H20237007 | 200mg/5mL | Category B | XJ01FAA051X006030105801 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20074239 | 0.25g | Category B | XJ01FAA051X006030105826 | NHSA |
| Pliva Croatia Ltd. | 国药准字HJ20160584 | 100mg/5ml | Category B | XJ01FAA051X006030179335 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20074239 | 0.25g | Category B | XJ01FAA051X006030205826 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20074239 | 0.25g | Category B | XJ01FAA051X006030305826 | NHSA |
| Hunan Di Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20057207 | 0.1g | Category B | XJ01FAA051X006030404914 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20074239 | 0.25g | Category B | XJ01FAA051X006030405826 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20074239 | 0.25g | Category B | XJ01FAA051X006030505826 | NHSA |
| Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized | 国药准字H20094126 | 0.1g | Category B | XJ01FAA051X006030604203 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20074239 | 0.25g | Category B | XJ01FAA051X006030605826 | NHSA |
| Shandong Zi Bo Xin Da Pharmaceutical Co., Ltd. romanized | 国药准字H20094126 | 0.1g | Category B | XJ01FAA051X006030704203 | NHSA |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | 国药准字H20074239 | 0.25g | Category B | XJ01FAA051X006030705826 | NHSA |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | 国药准字H10980217 | 0.1g | Category B | XJ01FAA051X006040102770 | NHSA |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 国药准字H20237002 | 100mg/5mL | Category B | XJ01FAA051X006040105801 | NHSA |
| Pliva Croatia Ltd. | 国药准字HJ20160585 | 200mg/5ml | Category B | XJ01FAA051X006040179335 | NHSA |
| Pliva Croatia Ltd. | 国药准字HJ20160585 | 200mg/5ml | Category B | XJ01FAA051X006050179335 | NHSA |
| Pliva Croatia Ltd. | 国药准字HJ20160614 | 200mg/5ml | Category B | XJ01FAA051X006060179335 | 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 3 · Supplement 3
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | CYHS2600122 | Generic | 2026/01/09 | Not stated by source | CDE |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CYHS2601965 | Generic | 2026/08/11 | Not stated by source | CDE |
| Nan Tong Jiu He Pharma Co., Ltd. romanized | CYHB2650166 | Supplement | 2026/07/27 | Not stated by source | CDE |
| Sichuan Pharmaceutical Formulations Co., Ltd. romanized | CYHB2550346 | Supplement | 2025/10/22 | Not stated by source | CDE |
| Guangdong Fang Sheng Jian Meng Pharma Co., Ltd. romanized | CYHS2503630 | Generic | 2025/10/11 | Not stated by source | CDE |
| Hainan Quan Xing Pharmaceutical Co., Ltd. romanized | CYHB2550300 | Supplement | 2025/08/22 | 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 |
|---|---|---|---|---|---|
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | CYHS2600122 | Generic | 2026/01/09 | Not stated by source | CDE |
| Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CYHS2601965 | Generic | 2026/08/11 | Not stated by source | CDE |
API registrations
Non-component matches: 34 companies with A status and 4 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 |
|---|---|---|---|---|---|---|
| 阿奇霉素 · No verified English name | Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized | Y20260000882 | I | Exact ingredient | 2026/10/21 | CDE |
| 阿奇霉素 · No verified English name | Pharmagen Ltd. | Y20250000419 | I | Exact ingredient | 2025/07/11 | CDE |
| 阿奇霉素 · No verified English name | Alembic Pharmaceuticals Limited | Y20240000887 | A | Exact ingredient | 2026/09/03 | CDE |
| 阿奇霉素 · No verified English name | Ningxia Tai Yi Xin Bio Technology Co., Ltd. romanized | Y20210000368 | A | Exact ingredient | 2026/03/02 | CDE |
| 阿奇霉素 · No verified English name | Pfizer Asia Manufacturing Pte Ltd | Y20200001087 | A | Exact ingredient | 2024/09/10 | CDE |
| 阿奇霉素 · No verified English name | Hunan Jiu Dian Hong Yang Pharmaceutical Co., Ltd. romanized | Y20180001793 | A | Exact ingredient | 2023/10/17 | CDE |
| 阿奇霉素 · No verified English name | TAPI Croatia Industries Ltd. | Y20190009959 | A | Exact ingredient | 2025/10/30 | CDE |
| 阿奇霉素 · No verified English name | Zhejiang Guo Bang Pharma Co., Ltd. romanized | Y20190009898 | A | Exact ingredient | 2024/07/03 | CDE |
| 阿奇霉素 · No verified English name | CSPC OUYI PHARMACEUTICAL CO., LTD. | Y20190009555 | A | Exact ingredient | 2024/07/09 | CDE |
| 阿奇霉素 · No verified English name | Pfizer Inc. | Y20190009141 | A | Exact ingredient | 2024/11/12 | CDE |
| 阿奇霉素 · No verified English name | Jiangsu Wei Qi Da Pharma Co., Ltd. romanized | Y20190008874 | A | Exact ingredient | 2026/08/06 | CDE |
| 阿奇霉素 · No verified English name | Huang Shi Shi Xing Pharma Co., Ltd. romanized | Y20190008850 | A | Exact ingredient | 2026/02/07 | CDE |
| 阿奇霉素 · No verified English name | Zhejiang Zhen Yuan Pharmaceutical Co., Ltd. romanized | Y20190007600 | A | Exact ingredient | 2024/06/12 | CDE |
| 阿奇霉素 · No verified English name | Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | Y20190006536 | A | Exact ingredient | 2025/07/23 | CDE |
| 阿奇霉素 · No verified English name | Topfond Pharmaceutical Co., Ltd. | Y20190006317 | A | Exact ingredient | 2024/11/01 | CDE |
| 阿奇霉素 · No verified English name | Ningxia Qi Yuan Pharma Co., Ltd. romanized | Y20190006173 | A | Exact ingredient | 2026/03/19 | CDE |
| 阿奇霉素 · No verified English name | Xian Li Jun Pharmaceutical Co., Ltd. romanized | Y20190005668 | A | Exact ingredient | 2026/01/07 | CDE |
| 阿奇霉素 · No verified English name | Beijing Tai Yang Pharma Co., Ltd. romanized | Y20190005484 | A | Exact ingredient | — | CDE |
| 阿奇霉素 · No verified English name | Yi Chang Dong Yang Guang Sheng Hua Pharmaceutical Co., Ltd. romanized | Y20190005339 | A | Exact ingredient | 2026/02/13 | CDE |
| 阿奇霉素 · No verified English name | Hebei Dong Feng Pharma Co., Ltd. romanized | Y20190004976 | A | Exact ingredient | 2025/02/09 | CDE |
| 阿奇霉素 · No verified English name | Zhejiang Bei De Pharma Co., Ltd. romanized | Y20190004814 | A | Exact ingredient | 2025/03/04 | CDE |
| 马来酸阿奇霉素 · No verified English name | Tianjin Bio Chemical Pharmaceutical Co., Ltd. romanized | Y20190004393 | A | Salt-normalized ingredient | 2025/08/16 | CDE |
| 阿奇霉素 · No verified English name | Tai Shan Shi Chemical Pharmaceutical Co., Ltd. romanized | Y20190004081 | A | Exact ingredient | — | CDE |
| 阿奇霉素 · No verified English name | Hua Bei Pharmaceutical Hebei Hua Min Pharma Co., Ltd. romanized | Y20190003842 | A | Exact ingredient | 2025/06/07 | CDE |
| 阿奇霉素 · No verified English name | He Ze Shi Fang Ming Pharmaceutical Co., Ltd. romanized | Y20190003689 | A | Exact ingredient | — | CDE |
| 阿奇霉素 · No verified English name | Zhejiang Nai Si Kang Pharma Co., Ltd. romanized | Y20190003585 | A | Exact ingredient | 2025/07/05 | CDE |
| 阿奇霉素 · No verified English name | Zhejiang Ao Tuo Kang Pharmaceutical Group Co., Ltd. romanized | Y20190003518 | A | Exact ingredient | — | CDE |
| 阿奇霉素 · No verified English name | Zhejiang Yong Ning Pharma Co., Ltd. romanized | Y20190003427 | A | Exact ingredient | 2024/12/10 | CDE |
| 盐酸阿奇霉素 · No verified English name | Nanjing Zhang Ao Pharmaceutical Co., Ltd. romanized | Y20190002838 | A | Salt-normalized ingredient | — | CDE |
| 硫酸阿奇霉素 · No verified English name | Zhejiang Jian Feng Pharma Co., Ltd. romanized | Y20190002579 | A | Salt-normalized ingredient | 2024/11/20 | CDE |
| 富马酸阿奇霉素 · No verified English name | De Zhou De Yao Pharmaceutical Co., Ltd. romanized | Y20190002300 | A | Salt-normalized ingredient | 2025/02/07 | CDE |
| 阿奇霉素 · No verified English name | Qilu Pharmaceutical Co., Ltd. | Y20190001577 | A | Exact ingredient | — | CDE |
| 阿奇霉素 · No verified English name | Shao Xing Xing Ya Pharma Co., Ltd. romanized | Y20190001524 | A | Exact ingredient | — | CDE |
| 阿奇霉素 · No verified English name | Sichuan Jiang Chuan Pharmaceutical Co., Ltd. romanized | Y20190001366 | A | Exact ingredient | — | CDE |
| 阿奇霉素 · No verified English name | Ru Yuan Dong Yang Guang Pharma Co., Ltd. romanized | Y20190000922 | A | Exact ingredient | 2023/08/14 | CDE |
| 阿奇霉素 · No verified English name | CSPC OUYI PHARMACEUTICAL CO., LTD. | Y20190000443 | I | Exact ingredient | 2019/06/12 | CDE |
| 阿奇霉素 · No verified English name | PLIVA Croatia Ltd. | Y20180001512 | I | Exact ingredient | 2019/02/03 | CDE |
| 阿奇霉素 · No verified English name | Hebei Guo Long Pharmaceutical Co., Ltd. romanized | Y20170000182 | A | Exact ingredient | 2024/10/24 | 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: 2026/11/14 06:40. NHSA records lack approval dates; only an earlier edition or observation establishes precedence.
-
2026/11/12No longer listed under review
Shandong Pu Rui Man Pharma Co., Ltd. romanized
CYHS2502380
Fact date: 2026/11/12 · Site observation date: 2026/11/12
Accepted: 2025/07/05
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/11/11No longer listed under review
Sichuan Pharmaceutical Formulations Co., Ltd. romanized
CYHB2501395
Fact date: 2026/11/11 · Site observation date: 2026/11/11
Accepted: 2025/07/14
not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/11/10 (approval no.: —; approval date: 2026/11/09); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 4
NMPA · Table row 4 ↗ View source ↗ -
2026/11/09Supplement delivery
Sichuan Pharmaceutical Formulations Co., Ltd. romanized
CYHB2501395
Fact date: 2026/11/09 · Publication date: 2026/11/10 · Site observation date: 2026/11/10
Supplemental application; excluded from new marketing approvals.
View source · Table row 4 ↗ -
2026/11/04No longer listed under review
Zhejiang Kang De Pharma Group Co., Ltd. romanized
CYHB2550339
Fact date: 2026/11/04 · Site observation date: 2026/11/04
Accepted: 2025/10/16
not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/11/03 (approval no.: —; approval date: 2026/11/02); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 3
NMPA · Table row 3 ↗ View source ↗ -
2026/11/02Supplement delivery
Zhejiang Kang De Pharma Group Co., Ltd. romanized
CYHB2550339
Fact date: 2026/11/02 · Publication date: 2026/11/03 · Site observation date: 2026/11/03
Supplemental application; excluded from new marketing approvals.
View source · Table row 3 ↗ -
2026/10/20Marketing application approved
Yun Peng Pharmaceuticals Group Co., Ltd. romanized
CYHS2501185 · 国药准字H20266378
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 46 ↗
How current is each source?
- CDE acceptances and review
- Last successful update: 2026/11/14 06:44
- Chemical-drug catalogue
- Last successful update: 2026/11/14 06:40
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: 2026/11/14 06:43
- 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: 2026/11/14 18:32
First index-page publication dates: 2026-10-29 to 2026-11-13; 0 pages pending. Covers loaded notices only, not a complete historical approval database.
- Drug Clinical Trial Registry and Information Disclosure Platform
- Last successful update: 2026/11/14 08:10 · 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: 0. 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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