Shandong Hua Bo Kai Sheng Bio Technology 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 a8c2f263b5
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
41 acceptance records as first applicant, grouped into 27 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.
注射用顺铂聚合物胶束 · No verified English name 1 records · Latest accepted 2026/06/16
New drug · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CXHL2600715 | New drug | 2026/06/16 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | CDE ↗ |
Minoxidil Liniment 8 records · Latest accepted 2026/05/08
Supplement · 6Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2600880 | Supplement | 2026/05/08 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2600879 | Supplement | 2026/05/08 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2600878 | Supplement | 2026/05/08 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2600877 | Supplement | 2026/05/08 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2600802 | Supplement | 2026/04/23 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CDE ↗ |
| CYHB2600801 | Supplement | 2026/04/23 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CDE ↗ |
| CYHS2400977 | Generic | 2024/03/30 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CDE ↗ |
| CYHS2400976 | Generic | 2024/03/30 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CDE ↗ |
Dapoxetine Hydrochloride Tablets 1 records · Latest accepted 2026/03/27
Supplement · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHB2600607 | Supplement | 2026/03/27 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CDE ↗ |
利多卡因丙胺卡因气雾剂 · No verified English name 2 records · Latest accepted 2026/01/29
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2600308 | Generic | 2026/01/29 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHL2400089 | Generic | 2024/05/11 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | CDE ↗ |
盐酸毛果芸香碱滴眼液 · No verified English name 2 records · Latest accepted 2025/07/09
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2502428 | Generic | 2025/07/09 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Jin Yao Yong Guang (Hebei) Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHL2300149 | Generic | 2023/12/09 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | CDE ↗ |
蒙脱石混悬液 · No verified English name 1 records · Latest accepted 2025/04/19
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2501498 | Generic | 2025/04/19 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Polidocanol Injection 1 records · Latest accepted 2025/04/15
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2501436 | Generic | 2025/04/15 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CDE ↗ |
Nifuratel And Nystatin Vaginal Soft Capsules 1 records · Latest accepted 2025/03/26
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHL2500069 | Generic | 2025/03/26 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | CDE ↗ |
Diquafosol Sodium Eye Drops 1 records · Latest accepted 2025/02/19
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2500796 | Generic | 2025/02/19 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Jin Yao Yong Guang (Hebei) Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Labetalol Hydrochloride Tablets 2 records · Latest accepted 2025/02/07
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2500583 | Generic | 2025/02/07 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2500582 | Generic | 2025/02/07 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Sodium sulfate, magnesium sulfate, and potassium chloride Tablets 2 records · Latest accepted 2024/11/22
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2404007 | Generic | 2024/11/22 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHL2300088 | Generic | 2023/07/18 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | CDE ↗ |
注射用紫杉醇聚合物胶束 · No verified English name 1 records · Latest accepted 2024/11/15
New drug · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CXHL2401237 | New drug | 2024/11/15 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | CDE ↗ |
Vardenafil Hydrochloride Tablets 2 records · Latest accepted 2024/09/11
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2402999 | Generic | 2024/09/11 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2400621 | Generic | 2024/02/20 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Thiamazole Tablets 2 records · Latest accepted 2024/04/26
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2401273 | Generic | 2024/04/26 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2401271 | Generic | 2024/04/26 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Alendronate Sodium Tablets 1 records · Latest accepted 2024/04/18
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2401153 | Generic | 2024/04/18 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CDE ↗ |
Rupatadine Fumarate Tablets 1 records · Latest accepted 2024/03/28
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2400932 | Generic | 2024/03/28 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Nimodipine Injection 1 records · Latest accepted 2024/03/01
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2400743 | Generic | 2024/03/01 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. | CDE ↗ |
Finasteride and Tadalafil Capsules 1 records · Latest accepted 2024/02/03
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2400454 | Generic | 2024/02/03 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Macitentan Tablets 1 records · Latest accepted 2023/12/22
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2303558 | Generic | 2023/12/22 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Baricitinib Tablets 1 records · Latest accepted 2023/09/13
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2302467 | Generic | 2023/09/13 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Pirfenidone Tablets 1 records · Latest accepted 2023/04/01
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2300947 | Generic | 2023/04/01 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Sildenafil Citrate Oral Disintegrating Tablets 1 records · Latest accepted 2023/03/02
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2300671 | Generic | 2023/03/02 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
孟鲁司特钠颗粒 · No verified English name 1 records · Latest accepted 2022/11/10
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2201928 | Generic | 2022/11/10 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Rasagiline Mesylate Tablets 1 records · Latest accepted 2022/04/22
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2200628 | Generic | 2022/04/22 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
重酒石酸卡巴拉汀胶囊 · No verified English name 2 records · Latest accepted 2022/03/24
Generic · 2
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2200482 | Generic | 2022/03/24 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| CYHS2200481 | Generic | 2022/03/24 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Argatroban Injection 1 records · Latest accepted 2021/07/02
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2101381 | Generic | 2021/07/02 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CDE ↗ |
Ornidazole Injection 1 records · Latest accepted 2021/06/21
Generic · 1
| Acceptance number | Application type | Accepted | Company / applicant | View source |
|---|---|---|---|---|
| CYHS2101322 | Generic | 2021/06/21 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Tong Hua Jin Ma Pharma Group Co., Ltd. romanized | CDE ↗ |
Changes in the last 90 days
8 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.
No longer listed under review: 4 applicationsNotification delivery: 4 applications
- 2026/10/23No longer listed under review
Minoxidil Liniment
CYHB2600880
Fact date: 2026/10/23 · Site observation date: 2026/10/23
Accepted: 2026/05/08
not on the CDE under-review list in this snapshot; NMPA published notification delivery for this acceptance number on 2026/10/22; the notification contents are not public and the outcome remains unverified; this is a supplemental application, not counted as a new marketing approval · NMPA source · row 5
NMPA · Table row 5 ↗ View source ↗ - 2026/10/23No longer listed under review
Minoxidil Liniment
CYHB2600879
Fact date: 2026/10/23 · Site observation date: 2026/10/23
Accepted: 2026/05/08
not on the CDE under-review list in this snapshot; NMPA published notification delivery for this acceptance number on 2026/10/22; the notification contents are not public and the outcome remains unverified; this is a supplemental application, not counted as a new marketing approval · NMPA source · row 4
NMPA · Table row 4 ↗ View source ↗ - 2026/10/23No longer listed under review
Minoxidil Liniment
CYHB2600878
Fact date: 2026/10/23 · Site observation date: 2026/10/23
Accepted: 2026/05/08
not on the CDE under-review list in this snapshot; NMPA published notification delivery for this acceptance number on 2026/10/22; the notification contents are not public and the outcome remains unverified; this is a supplemental application, not counted as a new marketing approval · NMPA source · row 3
NMPA · Table row 3 ↗ View source ↗ - 2026/10/23No longer listed under review
Minoxidil Liniment
CYHB2600877
Fact date: 2026/10/23 · Site observation date: 2026/10/23
Accepted: 2026/05/08
not on the CDE under-review list in this snapshot; NMPA published notification delivery for this acceptance number on 2026/10/22; the notification contents are not public and the outcome remains unverified; this is a supplemental application, not counted as a new marketing approval · NMPA source · row 2
NMPA · Table row 2 ↗ View source ↗ - 2026/10/22Notification delivery
Minoxidil Liniment
CYHB2600880
Fact date: 2026/10/22 (Publication date) · Publication date: 2026/10/22 · Site observation date: 2026/11/03
Notification delivered; the specific outcome remains to be checked.
View source · Table row 5 ↗ - 2026/10/22Notification delivery
Minoxidil Liniment
CYHB2600879
Fact date: 2026/10/22 (Publication date) · Publication date: 2026/10/22 · Site observation date: 2026/11/03
Notification delivered; the specific outcome remains to be checked.
View source · Table row 4 ↗ - 2026/10/22Notification delivery
Minoxidil Liniment
CYHB2600878
Fact date: 2026/10/22 (Publication date) · Publication date: 2026/10/22 · Site observation date: 2026/11/03
Notification delivered; the specific outcome remains to be checked.
View source · Table row 3 ↗ - 2026/10/22Notification delivery
Minoxidil Liniment
CYHB2600877
Fact date: 2026/10/22 (Publication date) · Publication date: 2026/10/22 · Site observation date: 2026/11/03
Notification delivered; the specific outcome remains to be checked.
View source · Table row 2 ↗
Under review
4 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 |
|---|---|---|---|---|---|
| Dapoxetine Hydrochloride Tablets | CYHB2600607 | Supplement | 2026/03/27 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized | CDE ↗ |
| 利多卡因丙胺卡因气雾剂 · No verified English name | CYHS2600308 | Generic | 2026/01/29 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| 盐酸毛果芸香碱滴眼液 · No verified English name | CYHS2502428 | Generic | 2025/07/09 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Jin Yao Yong Guang (Hebei) Pharmaceutical Co., Ltd. romanized | CDE ↗ |
| 蒙脱石混悬液 · No verified English name | CYHS2501498 | Generic | 2025/04/19 | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CDE ↗ |
Catalogue holder records
24 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 |
|---|---|---|---|---|---|---|
| Labetalol Hydrochloride Tablets | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20265979 | 2026/09/15 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Labetalol Hydrochloride Tablets | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20265980 | 2026/09/15 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Sodium sulfate, magnesium sulfate, and potassium chloride Tablets | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20264937 | 2026/06/23 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Macitentan Tablets | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20263801 | 2026/03/31 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Nimodipine Injection | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Sichuan Kelun Pharmaceutical Co., Ltd. | 国药准字H20263249 | 2026/01/27 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Finasteride and Tadalafil Capsules | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20256305 | 2025/12/16 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Thiamazole Tablets | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20256096 | 2025/12/03 | Not stated by source | CDE ↗ |
| Thiamazole Tablets | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20256095 | 2025/12/03 | Not stated by source | CDE ↗ |
| Baricitinib Tablets | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20256060 | 2025/11/25 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Alendronate Sodium Tablets | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20254876 | 2025/07/15 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Rupatadine Fumarate Tablets | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20253330 | 2025/01/24 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Pramipexole Dihydrochloride Prolonged-release Tablets | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20244543 | 2024/07/30 | Not stated by source | CDE ↗ |
| Pramipexole Dihydrochloride Prolonged-release Tablets | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20244542 | 2024/07/30 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| 孟鲁司特钠颗粒 · No verified English name | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20243754 | 2024/05/21 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Sildenafil Citrate Oral Disintegrating Tablets | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20243695 | 2024/05/15 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Rasagiline Mesylate Tablets | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20243700 | 2024/05/15 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| 重酒石酸卡巴拉汀胶囊 · No verified English name | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20234497 | 2023/11/21 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| 重酒石酸卡巴拉汀胶囊 · No verified English name | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20234498 | 2023/11/21 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Argatroban Injection | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20233471 | 2023/04/17 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Ornidazole Injection | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Tong Hua Jin Ma Pharma Group Co., Ltd. romanized | 国药准字H20233374 | 2023/03/24 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Tadalafil Tablets | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20223399 | 2022/06/16 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Tadalafil Tablets | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20223400 | 2022/06/16 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Tadalafil Tablets | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized | 国药准字H20223401 | 2022/06/16 | Generic approved under the new chemical-drug registration classification | CDE ↗ |
| Dapoxetine Hydrochloride Tablets | Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | Yan Tai Lu Yin Pharma Co., Ltd. romanized | 国药准字H20203169 | 2020/04/14 | Generic approved under the new chemical-drug registration classification | 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
0 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 |
|---|---|---|---|---|---|
| No matching records were found in the currently loaded source data; coverage dates are listed below. | |||||
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
10 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 |
|---|---|---|---|---|---|
| 过氧苯甲酰 · No verified English name | JTH2500001 | Not stated by source | 2025/01/03 | CAMBREX KARLSKOGA AB; Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | CDE ↗ |
| 比拉斯汀 · No verified English name | JTH2300114 | Not stated by source | 2023/05/07 | VIRUPAKSHA?ORGANICS?LIMITED UNIT-I; VIRUPAKSHA ORGANICS LIMITED UNIT-I; Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | CDE ↗ |
| 盐酸毛果芸香碱 · No verified English name | JTH2200194 | Not stated by source | 2022/09/17 | Anidro do Brasil Extracoes S.A.; Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | CDE ↗ |
| 马昔腾坦 · No verified English name | JTH2200103 | Not stated by source | 2022/06/03 | MSN LIFE SCIENCES PRIVATE LIMITED UNIT - II romanized; Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | CDE ↗ |
| 巴瑞替尼 · No verified English name | JTH2200068 | Not stated by source | 2022/03/31 | Natco Pharma Limited; Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | CDE ↗ |
| 盐酸毛果芸香碱 · No verified English name | JTH2200066 | Not stated by source | 2022/03/23 | Anidro do Brasil Extra??es S.A.; C-squared PHARMA S.a r.l.; Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | CDE ↗ |
| 巴瑞替尼 · No verified English name | JTH2200044 | Not stated by source | 2022/03/04 | Natco Pharma Limited; Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | CDE ↗ |
| 米拉贝隆 · No verified English name | JTH2200014 | Not stated by source | 2022/01/26 | Biocon Limited; Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | CDE ↗ |
| 米拉贝隆 · No verified English name | JTH2100695 | Not stated by source | 2021/11/25 | LUPIN LIMITED; Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized | CDE ↗ |
| 吡仑帕奈(3/4水合物) · No verified English name | JTH2100553 | Not stated by source | 2021/06/25 | MSN Organics Private Limited; Shandong Hua Bo Kai Sheng Bio Technology 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.