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Sign in to subscribeDapagliflozin and Metformin Hydrochloride Sustained-release Tablets(III)
As of 13 November 2026, for Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets(III), 25 applications are listed as under review at China's CDE; 9 companies have filed new generic applications in 2026; the chemical-drug catalogue lists 11 holders.
Companies, stages and changes, with each record available on this page.
Last 90 days: Marketing application approved: 2 applicationsAccepted: 2 applicationsNo longer listed under review: 1 application
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 holders11View records ↓
Under-review filings25View records ↓
This year’s generic filers9View records ↓
NHSA approval numbers10View records ↓
API companies with A status0View records ↓
Chemical-drug catalogue
Loaded records: 11 holders; 0 in the quality-and-efficacy consistency-evaluation category, and 11 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 |
|---|---|---|---|---|---|---|
| Shandong Lukang Pharmaceutical Co.,Ltd. | Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H20265611 | 2026/08/04 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20265309 | 2026/07/21 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H20265178 | 2026/07/14 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Jiangsu Vanguard Pharmaceutical Co., Ltd. | Jiangsu Vanguard Pharmaceutical Co., Ltd. | 国药准字H20264489 | 2026/05/19 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| CISEN PHARMACEUTICAL CO., LTD. | CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20264127 | 2026/04/21 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Wei Lin Heng Chang Pharmaceuticals Technology Co., Ltd. romanized | Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized | 国药准字H20255288 | 2025/09/02 | 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H20254139 | 2025/05/13 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Qilu Pharmaceutical Co., Ltd. | Qilu Pharmaceutical Co., Ltd. | 国药准字H20253378 | 2025/02/11 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Beijing Foyou Pharma CO.,LTD | Beijing Foyou Pharma CO.,LTD | 国药准字H20253200 | 2025/01/14 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20249467 | 2024/12/01 | See source | Generic approved under the new chemical-drug registration classification | CDE |
| Shanghai Xuan Tai Pharmaceuticals Technology Co., Ltd. romanized | Jiangsu Xuan Tai Pharma Co., Ltd. romanized | 国药准字H20244865 | 2024/09/10 | See source | Generic approved under the new chemical-drug registration classification | CDE |
Distinct full holder names; manufacturers are used only where the holder is unstated. The catalogue covers only part of the chemical-drug market. Categories are counted as recorded, not as a complete market census.
NHSA drug codes
Loaded records: 10 distinct approval numbers and 10 companies.
| Company / applicant | Approval number | Strength / specification | NHSA class | NHSA drug code | View source |
|---|---|---|---|---|---|
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253200 | See source | Not stated by source | XA10BDD368A010010100177 | NHSA |
| ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 国药准字H20254139 | See source | Not stated by source | XA10BDD368A010010104647 | NHSA |
| Beijing Foyou Pharma CO.,LTD | 国药准字H20253200 | See source | Not stated by source | XA10BDD368A010010200177 | NHSA |
| Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 国药准字H20249467 | See source | Not stated by source | XA10BDD368A010010101606 | NHSA |
| AstraZeneca AB | 国药准字HJ20230078 | See source | Not stated by source | XA10BDD368A010010179096 | NHSA |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H20265178 | See source | Not stated by source | XA10BDD368A010010103216 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20264127 | See source | Not stated by source | XA10BDD368A010010104127 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20265309 | See source | Not stated by source | XA10BDD368A010010106632 | NHSA |
| Shandong Lukang Pharmaceutical Co.,Ltd. | 国药准字H20265611 | See source | Not stated by source | XA10BDD368A010010183198 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20264127 | See source | Not stated by source | XA10BDD368A010010204127 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20265309 | See source | Not stated by source | XA10BDD368A010010206632 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20264127 | See source | Not stated by source | XA10BDD368A010010304127 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20265309 | See source | Not stated by source | XA10BDD368A010010306632 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20264127 | See source | Not stated by source | XA10BDD368A010010404127 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20265309 | See source | Not stated by source | XA10BDD368A010010406632 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20264127 | See source | Not stated by source | XA10BDD368A010010504127 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20265309 | See source | Not stated by source | XA10BDD368A010010506632 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20264127 | See source | Not stated by source | XA10BDD368A010010604127 | NHSA |
| Jiangsu Deyuan Pharmaceutical Co.,Ltd. | 国药准字H20265309 | See source | Not stated by source | XA10BDD368A010010606632 | NHSA |
| CISEN PHARMACEUTICAL CO., LTD. | 国药准字H20264127 | See source | Not stated by source | XA10BDD368A010010704127 | NHSA |
| You Hui Pharma (Beijing) Co., Ltd. romanized | 国药准字H20255288 | See source | Not stated by source | XA10BDD368A010010183203 | NHSA |
| Jiangsu Xuan Tai Pharma Co., Ltd. romanized | 国药准字H20244865 | See source | Not stated by source | XA10BDD368A010010183135 | NHSA |
| Jiangsu Xuan Tai Pharma Co., Ltd. romanized | 国药准字H20244865 | See source | Not stated by source | XA10BDD368A010010283135 | NHSA |
| Jiangsu Xuan Tai Pharma Co., Ltd. romanized | 国药准字H20244865 | See source | Not stated by source | XA10BDD368A010010383135 | NHSA |
| Jiangsu Xuan Tai Pharma Co., Ltd. romanized | 国药准字H20244865 | See source | Not stated by source | XA10BDD368A010010483135 | 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: 25 filings and 25 distinct first applicants.
Generic 22 · Supplement 1 · Import 2
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | CYHS2600557 | Generic | 2026/02/27 | Not stated by source | CDE |
| Anhui Pioneer Pharmaceutical Co., Ltd | CYHS2504058 | Generic | 2025/11/25 | Not stated by source | CDE |
| Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | CYHS2600905 | Generic | 2026/04/21 | Not stated by source | CDE |
| Yun Peng Pharmaceuticals Group Co., Ltd. romanized; Anhui Jia He Pharma Co., Ltd. romanized | CYHB2601514 | Supplement | 2026/08/10 | Not stated by source | CDE |
| Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized; Hubei Hua Shi Tong Biopharmaceuticals Technology Co., Ltd. romanized | CYHS2600845 | Generic | 2026/04/13 | Not stated by source | CDE |
| Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized | CYHS2600074 | Generic | 2026/01/08 | Not stated by source | CDE |
| Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized | CYHS2600024 | Generic | 2026/01/05 | Not stated by source | CDE |
| Jiangsu Ya Bang Ai Pu Sen Pharma Co., Ltd. romanized | CYHS2503602 | Generic | 2025/10/09 | Not stated by source | CDE |
| Beijing Sai Er Bio Pharma Co., Ltd. romanized | CYHS2504132 | Generic | 2025/12/02 | Not stated by source | CDE |
| Hefei Li Fang Pharmaceutical Co., Ltd. romanized | CYHS2504024 | Generic | 2025/11/21 | Not stated by source | CDE |
| Shaanxi Jun Ke Li Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Shi Pu Li Pharmaceutical Co., Ltd. romanized | CYHS2503193 | Generic | 2025/08/30 | Not stated by source | CDE |
| Henan Li Nuo Pharmaceutical Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized | CYHS2502717 | Generic | 2025/07/28 | Not stated by source | CDE |
| M/s Cipla Ltd.; Cipla (China) Pharmaceutical Co. Ltd | JYHS2500022 | Import | 2025/04/25 | Not stated by source | CDE |
| Shandong Ren He Pharmaceutical Co., Ltd. romanized | CYHS2602472 | Generic | 2026/10/10 | Not stated by source | CDE |
| MSN Laboratories Private Limited | JYHS2600022 | Import | 2026/09/23 | Not stated by source | CDE |
| Guo Da (Jilin) Pharmaceutical Group Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized | CYHS2601045 | Generic | 2026/05/08 | Not stated by source | CDE |
| Anhui Jia He Pharma Co., Ltd. romanized | CYHS2600978 | Generic | 2026/04/28 | Not stated by source | CDE |
| Shanxi Bao Tai Pharma Co., Ltd. romanized | CYHS2600943 | Generic | 2026/04/24 | Not stated by source | CDE |
| Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized | CYHS2503407 | Generic | 2025/09/16 | Not stated by source | CDE |
| Yi Nan Li Nuo Pharmaceutical Co., Ltd. romanized | CYHS2504243 | Generic | 2025/12/10 | Not stated by source | CDE |
| Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized | CYHS2503837 | Generic | 2025/10/31 | Not stated by source | CDE |
| CSPC OUYI PHARMACEUTICAL CO., LTD. | CYHS2503106 | Generic | 2025/08/23 | Not stated by source | CDE |
| Chongqing Bo Teng Pharma Co., Ltd. romanized | CYHS2502909 | Generic | 2025/08/11 | Not stated by source | CDE |
| Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized | CYHS2502207 | Generic | 2025/06/19 | Not stated by source | CDE |
| Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | CYHS2501603 | Generic | 2025/04/29 | Not stated by source | CDE |
New generic filings in 2026
Loaded records: 9 filings and 9 distinct first applicants.
| Company / applicant | Acceptance number | Application type | Accepted | Strength / specification | View source |
|---|---|---|---|---|---|
| Shanxi De Yuan Tang Pharma Co., Ltd. romanized | CYHS2600557 | Generic | 2026/02/27 | Not stated by source | CDE |
| Xin Shi Yang Guang Pharma (Hebei) Co., Ltd. romanized | CYHS2600905 | Generic | 2026/04/21 | Not stated by source | CDE |
| Zhong Mei Hua Shi Tong Biopharmaceuticals Technology (Wuhan) Co., Ltd. romanized; Hubei Hua Shi Tong Biopharmaceuticals Technology Co., Ltd. romanized | CYHS2600845 | Generic | 2026/04/13 | Not stated by source | CDE |
| Jiu Zhou Biopharmaceuticals (Tai Zhou) Co., Ltd. romanized | CYHS2600074 | Generic | 2026/01/08 | Not stated by source | CDE |
| Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized | CYHS2600024 | Generic | 2026/01/05 | Not stated by source | CDE |
| Shandong Ren He Pharmaceutical Co., Ltd. romanized | CYHS2602472 | Generic | 2026/10/10 | Not stated by source | CDE |
| Guo Da (Jilin) Pharmaceutical Group Co., Ltd. romanized; Chongqing Bo Teng Pharma Co., Ltd. romanized | CYHS2601045 | Generic | 2026/05/08 | Not stated by source | CDE |
| Anhui Jia He Pharma Co., Ltd. romanized | CYHS2600978 | Generic | 2026/04/28 | Not stated by source | CDE |
| Shanxi Bao Tai Pharma Co., Ltd. romanized | CYHS2600943 | Generic | 2026/04/24 | Not stated by source | CDE |
API registrations
Non-component matches: 0 companies with A status and 0 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 |
|---|---|---|---|---|---|---|
| 达格列净 · No verified English name | Topfond Pharmaceutical Co., Ltd. | Y20260000662 | I | Component match (excluded from headline counts) | 2026/08/17 | CDE |
| 达格列净 · No verified English name | Jiangsu A Er Fa Group Fu Rui Pharma (Su Qian) Co., Ltd. romanized | Y20260000249 | I | Component match (excluded from headline counts) | 2026/04/10 | CDE |
| 达格列净 · No verified English name | Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | Y20260000255 | I | Component match (excluded from headline counts) | 2026/04/09 | CDE |
| 达格列净 · No verified English name | Hunan Xian Shi Pharmaceutical Co., Ltd. romanized | Y20250001499 | I | Component match (excluded from headline counts) | 2026/01/13 | CDE |
| 达格列净 · No verified English name | Wu Xue Hong Yuan Pharma Co., Ltd. romanized | Y20250001044 | I | Component match (excluded from headline counts) | 2025/12/09 | CDE |
| 达格列净 · No verified English name | Changchun Hai Yue Pharma Co., Ltd. romanized | Y20250000937 | I | Component match (excluded from headline counts) | 2025/09/04 | CDE |
| 达格列净 · No verified English name | Zhejiang Jiang Bei Nan Hai Pharma Co., Ltd. romanized | Y20250000379 | A | Component match (excluded from headline counts) | 2026/10/16 | CDE |
| 盐酸二甲双胍 · No verified English name | Henan You Kai Pharmaceutical Co., Ltd. romanized | Y20250000327 | A | Component match (excluded from headline counts) | 2026/11/04 | CDE |
| 盐酸二甲双胍 · No verified English name | Shandong Lu Rui Pharma Co., Ltd. romanized | Y20250000352 | A | Component match (excluded from headline counts) | 2026/09/21 | CDE |
| 达格列净 · No verified English name | Chongqing Kai Lin Pharmaceutical Co., Ltd. romanized | Y20240001191 | A | Component match (excluded from headline counts) | 2026/05/12 | CDE |
| 达格列净 · No verified English name | Beijing Sai Er Bio Pharma Co., Ltd. romanized | Y20240001369 | A | Component match (excluded from headline counts) | 2026/04/21 | CDE |
| 达格列净 · No verified English name | Di Jia Pharma Group Co., Ltd. romanized | Y20240001043 | A | Component match (excluded from headline counts) | 2026/07/20 | CDE |
| 达格列净 · No verified English name | Honour Lab Limited Unit Iii | Y20240000587 | A | Component match (excluded from headline counts) | 2026/10/05 | CDE |
| 达格列净 · No verified English name | Shandong Cheng Hui Shuang Da Pharma Co., Ltd. romanized | Y20240000916 | A | Component match (excluded from headline counts) | 2026/10/17 | CDE |
| 盐酸二甲双胍 · No verified English name | Bai Yun Shandong Tai Shang Qiu Pharma Co., Ltd. romanized | Y20240000805 | A | Component match (excluded from headline counts) | 2026/03/15 | CDE |
| 达格列净 · No verified English name | Zhejiang Hong Yuan Pharma Co., Ltd. romanized | Y20240000845 | A | Component match (excluded from headline counts) | 2026/05/20 | CDE |
| 达格列净 · No verified English name | Wan Yang Heng Shui Pharmaceutical Co., Ltd. romanized | Y20240000873 | A | Component match (excluded from headline counts) | 2026/01/05 | CDE |
| 达格列净 · No verified English name | Zhejiang Ao Xiang Pharma Co., Ltd. romanized | Y20240000835 | A | Component match (excluded from headline counts) | 2025/12/29 | CDE |
| 达格列净 · No verified English name | Hubei Tian Shu Pharma Co., Ltd. romanized | Y20240000848 | A | Component match (excluded from headline counts) | 2026/10/27 | CDE |
| 达格列净 · No verified English name | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | Y20240000545 | A | Component match (excluded from headline counts) | 2026/09/05 | CDE |
| 盐酸二甲双胍 · No verified English name | Lai Yang Si Bang De Pharmaceutical Co., Ltd. romanized | Y20240000473 | A | Component match (excluded from headline counts) | 2025/12/12 | CDE |
| 达格列净 · No verified English name | Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized | Y20240000242 | A | Component match (excluded from headline counts) | 2025/09/04 | CDE |
| 达格列净 · No verified English name | Zhejiang Jiu Zhou Pharma Co., Ltd. romanized | Y20240000151 | A | Component match (excluded from headline counts) | 2025/10/17 | CDE |
| 盐酸二甲双胍 · No verified English name | Jilin Kai Lai Ying Pharmaceuticals Chemical Co., Ltd. romanized | Y20240000113 | A | Component match (excluded from headline counts) | 2025/11/10 | CDE |
| 达格列净 · No verified English name | Suzhou Zheng Ji Pharma Co., Ltd. romanized | Y20230000874 | A | Component match (excluded from headline counts) | 2026/03/27 | CDE |
| 达格列净 · No verified English name | Beijing Foyou Pharma CO.,LTD | Y20230000752 | A | Component match (excluded from headline counts) | 2024/12/13 | CDE |
| 达格列净 · No verified English name | Jiangsu Deyuan Pharmaceutical Co.,Ltd. | Y20230000695 | A | Component match (excluded from headline counts) | 2025/03/08 | CDE |
| 达格列净 · No verified English name | KRKA, d.d., Novo mesto | Y20230000350 | A | Component match (excluded from headline counts) | 2025/08/06 | CDE |
| 达格列净 · No verified English name | Zhi En Bio Technology Co., Ltd. romanized | Y20230000618 | A | Component match (excluded from headline counts) | 2026/06/04 | CDE |
| 达格列净 · No verified English name | Bai Yin Jing Yu Xin Pharma Co., Ltd. romanized | Y20230000626 | A | Component match (excluded from headline counts) | 2026/04/03 | CDE |
| 达格列净 · No verified English name | MSN Laboratories Private Limited | Y20230000345 | A | Component match (excluded from headline counts) | 2025/07/28 | CDE |
| 达格列净 · No verified English name | Hunan Jiu Dian Hong Yang Pharmaceutical Co., Ltd. romanized | Y20230000318 | A | Component match (excluded from headline counts) | 2026/06/09 | CDE |
| 达格列净 · No verified English name | Wei Fang Shi Hai Xin Pharma Co., Ltd. romanized | Y20230000410 | A | Component match (excluded from headline counts) | 2024/09/05 | CDE |
| 达格列净 · No verified English name | Han Rui Pharma (Jing Men) Co., Ltd. romanized | Y20230000355 | A | Component match (excluded from headline counts) | 2024/11/12 | CDE |
| 达格列净 · No verified English name | Cheng Da Pharma Co., Ltd. romanized | Y20230000033 | A | Component match (excluded from headline counts) | 2025/10/27 | CDE |
| 盐酸二甲双胍 · No verified English name | Sohan Healthcare Private Limited | Y20220000895 | A | Component match (excluded from headline counts) | 2026/01/22 | CDE |
| 达格列净 · No verified English name | Zhejiang Tian Yu Pharma Co., Ltd. romanized | Y20220001121 | A | Component match (excluded from headline counts) | 2025/04/11 | CDE |
| 盐酸二甲双胍 · No verified English name | Hebei Tian Cheng Pharma Co., Ltd. romanized | Y20220001156 | A | Component match (excluded from headline counts) | 2025/02/20 | CDE |
| 达格列净 · No verified English name | Biocon Limited | Y20220000163 | A | Component match (excluded from headline counts) | 2025/09/05 | CDE |
| 达格列净 · No verified English name | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | Y20220000893 | A | Component match (excluded from headline counts) | 2025/12/18 | CDE |
| 达格列净 · No verified English name | Xuan Cheng Mei Nuo Hua Pharma Co., Ltd. romanized | Y20220000754 | A | Component match (excluded from headline counts) | 2024/05/30 | CDE |
| 达格列净 · No verified English name | Fu Xin Long Rui Pharma Co., Ltd. romanized | Y20220000604 | A | Component match (excluded from headline counts) | 2025/05/14 | CDE |
| 达格列净 · No verified English name | Hebei Guo Long Pharmaceutical Co., Ltd. romanized | Y20220000818 | A | Component match (excluded from headline counts) | 2025/12/31 | CDE |
| 达格列净 · No verified English name | Jiangsu Hui Ju Pharma Co., Ltd. romanized | Y20220000848 | A | Component match (excluded from headline counts) | 2024/05/31 | CDE |
| 达格列净 · No verified English name | CSPC OUYI PHARMACEUTICAL CO., LTD. | Y20220000867 | A | Component match (excluded from headline counts) | 2025/10/23 | CDE |
| 达格列净 · No verified English name | MSN Laboratories Private Limited | Y20220000610 | I | Component match (excluded from headline counts) | 2023/11/03 | CDE |
| 盐酸二甲双胍 · No verified English name | Jiangsu Deyuan Pharmaceutical Co.,Ltd. | Y20220000686 | A | Component match (excluded from headline counts) | 2025/05/27 | CDE |
| 达格列净 · No verified English name | CSPC OUYI PHARMACEUTICAL CO., LTD. | Y20220000658 | I | Component match (excluded from headline counts) | 2022/08/22 | CDE |
| 盐酸二甲双胍 · No verified English name | Huadong Medicine (Xi’an)Bodyguard Pharmaceutical Co.,Ltd. | Y20220000357 | A | Component match (excluded from headline counts) | 2024/05/13 | CDE |
| 达格列净 · No verified English name | Dr.Reddy's Laboratories Ltd. | Y20220000123 | A | Component match (excluded from headline counts) | 2025/01/11 | CDE |
| 达格列净 · No verified English name | Jiangsu Hui Ju Pharma Co., Ltd. romanized | Y20220000259 | A | Component match (excluded from headline counts) | 2025/07/02 | CDE |
| 达格列净 · No verified English name | Cheng Da Pharma Co., Ltd. romanized | Y20220000029 | I | Component match (excluded from headline counts) | 2023/05/22 | CDE |
| 达格列净 · No verified English name | Sichuan Gowell Pharmaceutical Co., Ltd. | Y20210000979 | A | Component match (excluded from headline counts) | 2023/06/07 | CDE |
| 达格列净 · No verified English name | Jiangsu Pu Run Biopharmaceuticals Co., Ltd. romanized | Y20210001011 | A | Component match (excluded from headline counts) | 2024/03/21 | CDE |
| 盐酸二甲双胍 · No verified English name | IOL Chemicals and Pharmaceuticals Ltd. | Y20210000679 | A | Component match (excluded from headline counts) | 2024/02/18 | CDE |
| 达格列净 · No verified English name | AstraZeneca AB | Y20210000736 | A | Component match (excluded from headline counts) | 2026/05/20 | CDE |
| 达格列净 · No verified English name | Morepen Laboratories Ltd | Y20210000321 | I | Component match (excluded from headline counts) | 2021/07/30 | CDE |
| 达格列净 · No verified English name | Honour Lab Limited, Unit - III romanized | Y20210000221 | I | Component match (excluded from headline counts) | 2024/02/27 | CDE |
| 达格列净 · No verified English name | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | Y20210000556 | A | Component match (excluded from headline counts) | 2023/06/29 | CDE |
| 达格列净 · No verified English name | AstraZeneca AB | Y20210000271 | A | Component match (excluded from headline counts) | 2026/08/21 | CDE |
| 盐酸二甲双胍 · No verified English name | SMRUTHI ORGANICS LIMITED | Y20200001011 | I | Component match (excluded from headline counts) | 2021/05/25 | CDE |
| 盐酸二甲双胍 · No verified English name | Topfond Pharmaceutical Co., Ltd. | Y20200001441 | A | Component match (excluded from headline counts) | 2022/08/31 | CDE |
| 达格列净 · No verified English name | Dr. Reddy's Laboratories Ltd. | Y20210000100 | A | Component match (excluded from headline counts) | 2026/11/08 | CDE |
| 达格列净 · No verified English name | Xin Xiang Shuang Lu Pharma Co., Ltd. romanized | Y20200001479 | A | Component match (excluded from headline counts) | 2023/05/06 | CDE |
| 盐酸二甲双胍 · No verified English name | Shandong Shou Guang Bo Kang Pharmaceutical Co., Ltd. romanized | Y20200001309 | A | Component match (excluded from headline counts) | 2024/06/14 | CDE |
| 盐酸二甲双胍 · No verified English name | HARMAN FINOCHEM LIMITED | Y20200001045 | A | Component match (excluded from headline counts) | 2024/11/21 | CDE |
| 盐酸二甲双胍 · No verified English name | Harman Finochem Limited | Y20200000973 | A | Component match (excluded from headline counts) | 2023/03/24 | CDE |
| 达格列净 · No verified English name | ZCL Chemicals Limited | Y20200000919 | I | Component match (excluded from headline counts) | 2023/03/24 | CDE |
| 盐酸二甲双胍 · No verified English name | Ningxia Heng Kang Technology Co., Ltd. romanized | Y20200001044 | A | Component match (excluded from headline counts) | 2024/01/17 | CDE |
| 盐酸二甲双胍 · No verified English name | Abhilasha Pharma Pvt. Ltd. | Y20190021198 | A | Component match (excluded from headline counts) | 2022/10/31 | CDE |
| 盐酸二甲双胍 · No verified English name | Exemed Pharmaceuticals | Y20200000139 | A | Component match (excluded from headline counts) | 2022/11/07 | CDE |
| 盐酸二甲双胍 · No verified English name | Laurus Labs Limited | Y20200000513 | A | Component match (excluded from headline counts) | 2024/08/09 | CDE |
| 盐酸二甲双胍 · No verified English name | Apitoria Pharma Private Limited | Y20200000422 | A | Component match (excluded from headline counts) | 2025/04/10 | CDE |
| 达格列净 · No verified English name | Honour Lab Limited, Unit-III | Y20200000244 | A | Component match (excluded from headline counts) | 2024/01/31 | CDE |
| 盐酸二甲双胍 · No verified English name | Wanbury Limited | Y20200000314 | A | Component match (excluded from headline counts) | 2022/10/14 | CDE |
| 达格列净 · No verified English name | Beijing Foyou Pharma CO.,LTD | Y20200000298 | A | Component match (excluded from headline counts) | 2026/05/15 | CDE |
| 盐酸二甲双胍 · No verified English name | MERCK SANTE SAS | Y20190009925 | A | Component match (excluded from headline counts) | — | CDE |
| 盐酸二甲双胍 · No verified English name | Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized | Y20190009726 | A | Component match (excluded from headline counts) | 2026/01/24 | CDE |
| 盐酸二甲双胍 · No verified English name | Tianjin Tai Ping Yang Chemical Pharmaceutical Co., Ltd. romanized | Y20190009517 | A | Component match (excluded from headline counts) | 2025/06/14 | CDE |
| 盐酸二甲双胍 · No verified English name | Shandong Ke Yuan Pharmaceutical Co., Ltd. romanized | Y20190009395 | A | Component match (excluded from headline counts) | 2026/07/07 | CDE |
| 盐酸二甲双胍 · No verified English name | Aarti Drugs Ltd. | Y20190009174 | A | Component match (excluded from headline counts) | 2025/08/06 | CDE |
| 盐酸二甲双胍 · No verified English name | Qu Fu Sheng Ren Pharmaceutical Co., Ltd. romanized | Y20190008915 | A | Component match (excluded from headline counts) | 2022/10/28 | CDE |
| 盐酸二甲双胍 · No verified English name | Shijiazhuang Shi Pu Li Pharmaceutical Co., Ltd. romanized | Y20190008451 | A | Component match (excluded from headline counts) | 2025/01/03 | CDE |
| 盐酸二甲双胍 · No verified English name | Jiangsu Han Si Tong Pharma Co., Ltd. romanized | Y20190007133 | A | Component match (excluded from headline counts) | — | CDE |
| 盐酸二甲双胍 · No verified English name | Huai Nan Shun Long Pharmaceutical Co., Ltd. romanized | Y20190006466 | A | Component match (excluded from headline counts) | 2026/06/23 | CDE |
| 盐酸二甲双胍 · No verified English name | Hua Run Shuang He Pharma Co., Ltd. romanized | Y20190006308 | A | Component match (excluded from headline counts) | 2023/03/24 | CDE |
| 盐酸二甲双胍 · No verified English name | Jiangsu Tong He Pharma Co., Ltd. romanized | Y20190006246 | A | Component match (excluded from headline counts) | — | CDE |
| 盐酸二甲双胍 · No verified English name | Jilin Jin Heng Pharmaceutical Co., Ltd. romanized | Y20190006023 | A | Component match (excluded from headline counts) | 2026/01/27 | CDE |
| 盐酸二甲双胍 · No verified English name | Hao Yi Sheng Pharma Group Co., Ltd. romanized | Y20190005982 | A | Component match (excluded from headline counts) | — | CDE |
| 盐酸二甲双胍 · No verified English name | Jilin Sheng Si He Pharma Technology Co., Ltd. romanized | Y20190005512 | A | Component match (excluded from headline counts) | 2025/01/04 | CDE |
| 盐酸二甲双胍 · No verified English name | null | Y20190004800 | A | Component match (excluded from headline counts) | 2024/06/06 | CDE |
| 盐酸二甲双胍 · No verified English name | Fu Xiang (Da Lian) Pharmaceutical Co., Ltd. romanized | Y20190004140 | A | Component match (excluded from headline counts) | — | CDE |
| 盐酸二甲双胍 · No verified English name | Dan Dong Yi Chuang Pharma Co., Ltd. romanized | Y20190003827 | A | Component match (excluded from headline counts) | 2025/06/07 | CDE |
| 盐酸二甲双胍 · No verified English name | Tianjin Zhong Xin Pharma Group Co., Ltd. Xin Xin Pharmaceutical Factory romanized | Y20190002946 | A | Component match (excluded from headline counts) | 2023/03/24 | CDE |
| 盐酸二甲双胍 · No verified English name | null | Y20190002602 | A | Component match (excluded from headline counts) | 2024/10/24 | CDE |
| 盐酸二甲双胍 · No verified English name | FARMHISPANIA, S.A. | Y20190000147 | I | Component match (excluded from headline counts) | 2019/09/27 | CDE |
| 达格列净 · No verified English name | Shandong Lukang Pharmaceutical Co.,Ltd. | Y20190000428 | A | Component match (excluded from headline counts) | 2026/07/24 | CDE |
| 盐酸二甲双胍 · No verified English name | Vistin Pharma AS | Y20190000108 | A | Component match (excluded from headline counts) | 2026/09/24 | CDE |
| 盐酸二甲双胍 · No verified English name | MERCK SANTE S.A.S. | Y20180001691 | A | Component match (excluded from headline counts) | 2026/03/20 | CDE |
| 盐酸二甲双胍 · No verified English name | Tianjin Tai Ping Yang Chemical Pharmaceutical Co., Ltd. romanized | Y20180000014 | I | Component match (excluded from headline counts) | 2018/10/22 | CDE |
| 盐酸二甲双胍 · No verified English name | Shandong Ke Yuan Pharmaceutical Co., Ltd. romanized | Y20180000016 | A | Component match (excluded from headline counts) | 2023/08/14 | CDE |
| 盐酸二甲双胍 · No verified English name | Shou Guang Fu Kang Pharmaceutical Co., Ltd. romanized | Y20180000778 | A | Component match (excluded from headline counts) | — | CDE |
| 盐酸二甲双胍 · No verified English name | MERCK SANTE SAS | Y20170002070 | A | Component match (excluded from headline counts) | 2024/11/17 | CDE |
| 达格列净 · No verified English name | Anhui Sen Ji Pharmaceutical Co., Ltd. romanized | Y20260000911 | I | Component match (excluded from headline counts) | 2026/11/02 | 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
Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized
CYHS2502548 · 国药准字H20266523
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 95 ↗ -
2026/10/28No longer listed under review
Fu Xing Pharmaceuticals (Xu Zhou) Co., Ltd. romanized
CYHS2501345
Fact date: 2026/10/28 · Site observation date: 2026/10/28
Accepted: 2025/04/09
not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked
View source ↗ -
2026/10/20Marketing application approved
Hefei He Yuan Pharma Co., Ltd. romanized
CYHS2503028 · 国药准字H20266338
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 100 ↗ -
2026/10/10Accepted
Shandong Ren He Pharmaceutical Co., Ltd. romanized
CYHS2602472
Fact date: 2026/10/10 · Site observation date: 2026/10/21
View source ↗ -
2026/09/23Accepted
MSN Laboratories Private Limited
JYHS2600022
Fact date: 2026/09/23 · 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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