Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized
Check drug filings and source records for this company-name string.
Listed by the company name as recorded in the source, without merging affiliated entities.
Page reference 2f889c0c87
These counts cover loaded acceptance records only. First-applicant and co-applicant counts are not added together. CDE data as of 2026/11/13 06:42.
Drug filings
58 acceptance records as first applicant, grouped into 38 source drug names. Source data as of 2026/11/13 06:42.
Acceptance records are de-duplicated by acceptance number. Drug names are normalized only for width and whitespace; dosage forms and combinations remain separate. Application types are retained from the source. Expand a drug to inspect each record. Published drugs link to their drug pages; other names do not create new public drug pages.
Dapagliflozin Tablets 2 records · Latest accepted 2026/08/28
Generic · 2
Ilaprazole Enteric-coated Tablets 2 records · Latest accepted 2026/08/20
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2602077 | Generic | 2026/08/20 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Jilin Si Huan Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2501362 | Generic | 2025/04/09 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Jilin Si Huan Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Azithromycin for Suspension 1 records · Latest accepted 2026/08/11
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2601965 | Generic | 2026/08/11 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
Crisaborole Ointment 1 records · Latest accepted 2026/07/24
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2601424 | Supplement | 2026/07/24 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Nifedipine Controlled-release Tablets 1 records · Latest accepted 2026/06/23
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2601467 | Generic | 2026/06/23 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CDE ↗ |
Vardenafil Hydrochloride Tablets 3 records · Latest accepted 2026/05/08
Supplement · 3
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2600870 | Supplement | 2026/05/08 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHB2500808 | Supplement | 2025/04/24 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHB2500807 | Supplement | 2025/04/24 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Sildenafil Citrate Tablets 3 records · Latest accepted 2026/03/02
Supplement · 3
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2600420 | Supplement | 2026/03/02 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHB2600419 | Supplement | 2026/03/02 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHB2600418 | Supplement | 2026/03/02 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
诺氟沙星胶囊 · No verified English name 1 records · Latest accepted 2025/12/17
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2550400 | Supplement | 2025/12/17 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
Letermovir Injection 1 records · Latest accepted 2025/11/01
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2503850 | Generic | 2025/11/01 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized | CDE ↗ |
Ketorolac Tromethamine Injection 1 records · Latest accepted 2025/10/24
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2502202 | Supplement | 2025/10/24 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Methocarbamol Injection 1 records · Latest accepted 2025/08/02
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2501524 | Supplement | 2025/08/02 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized | CDE ↗ |
Amikacin Sulfate injection 1 records · Latest accepted 2025/07/18
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2550260 | Supplement | 2025/07/18 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
Baricitinib Tablets 1 records · Latest accepted 2025/07/16
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2502558 | Generic | 2025/07/16 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
托吡酯口服溶液 · No verified English name 1 records · Latest accepted 2025/06/12
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2502105 | Generic | 2025/06/12 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CDE ↗ |
Sacubitril Valsartan Sodium Tablets 3 records · Latest accepted 2025/04/12
Generic · 3
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2501417 | Generic | 2025/04/12 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
| CYHS2501416 | Generic | 2025/04/12 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
| CYHS2501415 | Generic | 2025/04/12 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
Iron Proteinsuccinylate Oral Solution 1 records · Latest accepted 2025/04/10
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2501385 | Generic | 2025/04/10 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized | CDE ↗ |
Rosuvastatin Calcium and Ezetimibe Tablets (I) 1 records · Latest accepted 2025/04/08
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2501321 | Generic | 2025/04/08 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Rui Hua (Zhong Shan) Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Linagliptin Tablets 1 records · Latest accepted 2024/09/26
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2401565 | Supplement | 2024/09/26 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Phloroglucinol Injection 1 records · Latest accepted 2024/09/14
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2401485 | Supplement | 2024/09/14 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Shanxi Wei Qi Da Guang Ming Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Dapoxetine Hydrochloride Tablets 4 records · Latest accepted 2024/09/02
Supplement · 4
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2401372 | Supplement | 2024/09/02 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Jiangxi Shimei Pharmaceutical Co., Ltd | CDE ↗ |
| CYHB2401371 | Supplement | 2024/09/02 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Jiangxi Shimei Pharmaceutical Co., Ltd | CDE ↗ |
| CYHB2400880 | Supplement | 2024/06/25 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Jiangxi Shimei Pharmaceutical Co., Ltd | CDE ↗ |
| CYHB2400879 | Supplement | 2024/06/25 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Jiangxi Shimei Pharmaceutical Co., Ltd | CDE ↗ |
Minoxidil Liniment 2 records · Latest accepted 2024/08/10
Generic · 2
Finasteride Tablets 2 records · Latest accepted 2024/07/19
Generic · 2
Azithromycin Tablets 1 records · Latest accepted 2024/06/01
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2450313 | Supplement | 2024/06/01 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
Cimetidine Injection 1 records · Latest accepted 2023/12/26
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2350969 | Supplement | 2023/12/26 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
Haloperidol Lactate Injection 1 records · Latest accepted 2023/11/11
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2350827 | Supplement | 2023/11/11 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
Tadalafil Tablets 4 records · Latest accepted 2023/09/15
Supplement · 4
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2302097 | Supplement | 2023/09/15 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
| CYHB2301204 | Supplement | 2023/05/24 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
| CYHB2301203 | Supplement | 2023/05/24 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
| CYHB2101873 | Supplement | 2021/09/22 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
Esmolol Hydrochloride Injection 1 records · Latest accepted 2023/09/02
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2350666 | Supplement | 2023/09/02 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
腺苷钴胺胶囊 · No verified English name 1 records · Latest accepted 2023/05/17
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2301332 | Generic | 2023/05/17 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
Moxifloxacin Hydrochloride And Sodium Chloride Injection 1 records · Latest accepted 2023/04/05
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2300979 | Generic | 2023/04/05 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
Doxofylline Injection 1 records · Latest accepted 2023/02/23
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2300616 | Generic | 2023/02/23 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
Ambroxol Hydrochloride Injection 2 records · Latest accepted 2022/08/12
Supplement · 2
硝苯地平缓释片(I) · No verified English name 1 records · Latest accepted 2022/07/18
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2250444 | Supplement | 2022/07/18 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
Ornidazole Tablets 2 records · Latest accepted 2022/06/20
Supplement · 2
Glipizide Tablets 1 records · Latest accepted 2022/02/17
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2250058 | Supplement | 2022/02/17 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
Simvastatin Tablets 2 records · Latest accepted 2021/09/15
Supplement · 2
Gliclazide Modified Release Tablets 1 records · Latest accepted 2021/06/18
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2150673 | Supplement | 2021/06/18 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
Isosorbide Mononitrate Extended-Release Tablets 1 records · Latest accepted 2021/06/17
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2150665 | Supplement | 2021/06/17 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
Atorvastatin Calcium Tablets 2 records · Latest accepted 2021/05/21
Generic · 2
Changes in the last 90 days
5 events from 2026/08/16 to 2026/11/13. CDE data as of 2026/11/13 06:42; NMPA data as of 2026/11/12 18:32.
This source was last successfully updated at 2026/11/12 18:32; current coverage may be incomplete.
Last 90 days, ordered by fact date. Marketing approvals, trial registrations, supplements, notices and review changes are labelled separately. 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.
Accepted: 3 applicationsNotification delivery: 2 applications
- 2026/10/21Notification delivery
Sacubitril Valsartan Sodium Tablets
CYHS2501417
Fact date: 2026/10/21 (Publication date) · Publication date: 2026/10/21 · Site observation date: 2026/11/03
Notification delivered; the specific outcome remains to be checked.
View source · Table row 6 ↗ - 2026/10/21Notification delivery
Sacubitril Valsartan Sodium Tablets
CYHS2501416
Fact date: 2026/10/21 (Publication date) · Publication date: 2026/10/21 · Site observation date: 2026/11/03
Notification delivered; the specific outcome remains to be checked.
View source · Table row 5 ↗ - 2026/08/28Accepted
Dapagliflozin Tablets
CYHS2602153
Fact date: 2026/08/28 · Site observation date: 2026/10/21
View source ↗ - 2026/08/28Accepted
Dapagliflozin Tablets
CYHS2602152
Fact date: 2026/08/28 · Site observation date: 2026/10/21
View source ↗ - 2026/08/20Accepted
Ilaprazole Enteric-coated Tablets
CYHS2602077
Fact date: 2026/08/20 · Site observation date: 2026/10/21
View source ↗
Under review
10 acceptance numbers with this company as first applicant are currently listed as under review by CDE. Source data as of 2026/11/13 06:42.
| Drug | Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|---|
| Dapagliflozin Tablets | CYHS2602153 | Generic | 2026/08/28 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
| Dapagliflozin Tablets | CYHS2602152 | Generic | 2026/08/28 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
| Ilaprazole Enteric-coated Tablets | CYHS2602077 | Generic | 2026/08/20 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Jilin Si Huan Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| Azithromycin for Suspension | CYHS2601965 | Generic | 2026/08/11 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
| Nifedipine Controlled-release Tablets | CYHS2601467 | Generic | 2026/06/23 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CDE ↗ |
| 诺氟沙星胶囊 · No verified English name | CYHB2550400 | Supplement | 2025/12/17 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
| Letermovir Injection | CYHS2503850 | Generic | 2025/11/01 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized | CDE ↗ |
| Baricitinib Tablets | CYHS2502558 | Generic | 2025/07/16 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| 托吡酯口服溶液 · No verified English name | CYHS2502105 | Generic | 2025/06/12 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd | CDE ↗ |
| Iron Proteinsuccinylate Oral Solution | CYHS2501385 | Generic | 2025/04/10 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized | CDE ↗ |
Catalogue holder records
26 loaded active catalogue records whose holder name matches this source company name. Source data as of 2026/11/13 06:39. Manufacturer-only records are excluded.
| Drug | Marketing authorization holder | Manufacturer | Approval number | Approved | Catalogue category (source text) | View source |
|---|---|---|---|---|---|---|
| Rosuvastatin Calcium and Ezetimibe Tablets (I) | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Rui Hua (Zhong Shan) Pharmaceutical Co., Ltd. romanized | 国药准字H20265028 | 2026/06/30 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Finasteride Tablets | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20256366 | 2025/12/22 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Finasteride Tablets | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20256367 | 2025/12/22 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Vardenafil Hydrochloride Tablets | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20254953 | 2025/07/29 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Azithromycin Tablets | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20033298 | 2025/05/24 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Linagliptin Tablets | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lang Nuo Pharmaceutical Co., Ltd. romanized | 国药准字H20253271 | 2025/01/24 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Esmolol Hydrochloride Injection | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20067704 | 2024/11/12 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Haloperidol Lactate Injection | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H37024042 | 2024/10/30 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Moxifloxacin Hydrochloride And Sodium Chloride Injection | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20249030 | 2024/10/09 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| 腺苷钴胺胶囊 · No verified English name | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20244652 | 2024/08/05 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Tadalafil Tablets | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20247157 | 2024/07/09 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Tadalafil Tablets | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20247156 | 2024/07/09 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Doxofylline Injection | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20243777 | 2024/05/21 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Ambroxol Hydrochloride Injection | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20203543 | 2023/10/07 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Ambroxol Hydrochloride Injection | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20203542 | 2023/10/07 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Ornidazole Tablets | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20133070 | 2023/09/11 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Ornidazole Tablets | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20133070 | 2023/09/11 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| 硝苯地平缓释片(I) · No verified English name | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20094073 | 2023/08/31 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Atorvastatin Calcium Tablets | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20233331 | 2023/03/24 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Atorvastatin Calcium Tablets | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20233330 | 2023/03/24 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Glipizide Tablets | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20046471 | 2022/11/02 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Simvastatin Tablets | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20083839 | 2022/08/23 | Not stated by source | CDE ↗ |
| Simvastatin Tablets | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20083840 | 2022/08/23 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Isosorbide Mononitrate Extended-Release Tablets | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20083838 | 2022/07/04 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Gliclazide Modified Release Tablets | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20083477 | 2022/03/25 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
| Tinidazole Tablets | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | 国药准字H20033090 | 2022/01/19 | Drug that passed quality-and-efficacy consistency evaluation | CDE ↗ |
Only active catalogue records matching the source holder name are listed. A manufacturer role does not count as a holder record. The catalogue covers only part of the chemical-drug market; source categories do not establish complete market coverage or qualifications.
API registrations
2 loaded active API registrations whose first registered company matches this source company name. Source data as of 2026/11/13 06:41.
| Name | Company / applicant | Registration number | Status | Source update date | View source |
|---|---|---|---|---|---|
| 氯贝酸铝 · No verified English name | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Y20190002054 | A | 2025/04/04 | CDE ↗ |
| 西洛他唑 · No verified English name | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | Y20190002004 | A | — | CDE ↗ |
Only loaded active API registrations not listed as cancelled are shown. A/I are source registration statuses. Records are listed by registration number and do not establish capacity or supply. The register does not identify the associated formulation.
Co-applicant records
9 acceptance records name this company after the first applicant. They are listed separately and are not included in first-applicant drug or filing counts. Source data as of 2026/11/13 06:42.
| Drug | Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|---|
| Levofloxacin Tablets | CYHS2602280 | Generic | 2026/09/15 | Shandong Kang Lin Pharmaceuticals Co., Ltd. romanized; Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
| 聚乙二醇钠钾散 · No verified English name | CYHB2600649 | Supplement | 2026/04/01 | Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
| Atorvastatin Calcium Tablets | CYHB2401493 | Supplement | 2024/09/14 | Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized; Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
| Atorvastatin Calcium Tablets | CYHB2401492 | Supplement | 2024/09/14 | Jiangsu Nuo Tai Ao Sai Nuo Biopharmaceutical Co., Ltd. romanized; Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
| Levofloxacin Tablets | CYHS2400605 | Generic | 2024/02/09 | Shandong Kang Lin Pharmaceuticals Co., Ltd. romanized; Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
| Levofloxacin Tablets | CYHS2400604 | Generic | 2024/02/09 | Shandong Kang Lin Pharmaceuticals Co., Ltd. romanized; Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
| 聚乙二醇钠钾散 · No verified English name | CYHS2201777 | Generic | 2022/10/19 | Shandong Xin Hua Lu Kang Pharmaceuticals Co., Ltd. romanized; Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
| Dapoxetine Hydrochloride Tablets | CYHS2200338 | Generic | 2022/02/17 | Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
| 聚乙二醇4000散 · No verified English name | CYHS2100049 | Generic | 2021/01/13 | Guangzhou Shi Ji Pharmaceuticals Technology Co., Ltd. romanized; Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized | CDE ↗ |
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
- Full API register
- Last successful update: 2026/11/13 06:41
- 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.
Listed by the company name as recorded in the source, without merging affiliated entities.
This page summarizes loaded records only, without new source queries or collection. Parent companies, subsidiaries, former names and aliases are not merged. Counts from different sources must not be added together. No loaded record does not establish the absence of a filing or registration. Check original records where coverage is incomplete, an update has failed, or a source lies outside the loaded scope.
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.
Drugs with a verified official English name use that name only. Other drug names retain the Chinese source name marked No verified English name; names with a Chinese public page link to that page. Company labels use verified official names, Latin source names, then fixed-rule transliterations marked romanized; Chinese company names are not displayed. Marked unverified drug names and original statutory reference numbers may appear in Chinese.
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.