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Company directoryChina company filings

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

Complete CDE snapshot
2026/11/13 06:42
Matching scope
Loaded public-source records only

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

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CXHL2600715New drug2026/06/16Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedCDE ↗
Minoxidil Liniment 8 records · Latest accepted 2026/05/08

Supplement · 6Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2600880Supplement2026/05/08Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanizedCDE ↗
CYHB2600879Supplement2026/05/08Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanizedCDE ↗
CYHB2600878Supplement2026/05/08Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanizedCDE ↗
CYHB2600877Supplement2026/05/08Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanizedCDE ↗
CYHB2600802Supplement2026/04/23Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanizedCDE ↗
CYHB2600801Supplement2026/04/23Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanizedCDE ↗
CYHS2400977Generic2024/03/30Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanizedCDE ↗
CYHS2400976Generic2024/03/30Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanizedCDE ↗
Dapoxetine Hydrochloride Tablets 1 records · Latest accepted 2026/03/27

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2600607Supplement2026/03/27Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanizedCDE ↗
利多卡因丙胺卡因气雾剂 · No verified English name 2 records · Latest accepted 2026/01/29

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2600308Generic2026/01/29Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Lu Nan Bei Te Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHL2400089Generic2024/05/11Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedCDE ↗
盐酸毛果芸香碱滴眼液 · No verified English name 2 records · Latest accepted 2025/07/09

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2502428Generic2025/07/09Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Jin Yao Yong Guang (Hebei) Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHL2300149Generic2023/12/09Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedCDE ↗
蒙脱石混悬液 · No verified English name 1 records · Latest accepted 2025/04/19

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2501498Generic2025/04/19Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanizedCDE ↗
Polidocanol Injection 1 records · Latest accepted 2025/04/15

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2501436Generic2025/04/15Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanizedCDE ↗
Nifuratel And Nystatin Vaginal Soft Capsules 1 records · Latest accepted 2025/03/26

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHL2500069Generic2025/03/26Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedCDE ↗
Diquafosol Sodium Eye Drops 1 records · Latest accepted 2025/02/19

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2500796Generic2025/02/19Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Jin Yao Yong Guang (Hebei) Pharmaceutical Co., Ltd. romanizedCDE ↗
Labetalol Hydrochloride Tablets 2 records · Latest accepted 2025/02/07

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2500583Generic2025/02/07Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2500582Generic2025/02/07Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
Sodium sulfate, magnesium sulfate, and potassium chloride Tablets 2 records · Latest accepted 2024/11/22

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2404007Generic2024/11/22Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHL2300088Generic2023/07/18Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedCDE ↗
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

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CXHL2401237New drug2024/11/15Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedCDE ↗
Vardenafil Hydrochloride Tablets 2 records · Latest accepted 2024/09/11

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2402999Generic2024/09/11Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2400621Generic2024/02/20Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
Thiamazole Tablets 2 records · Latest accepted 2024/04/26

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2401273Generic2024/04/26Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2401271Generic2024/04/26Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
Alendronate Sodium Tablets 1 records · Latest accepted 2024/04/18

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2401153Generic2024/04/18Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanizedCDE ↗
Rupatadine Fumarate Tablets 1 records · Latest accepted 2024/03/28

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2400932Generic2024/03/28Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
Nimodipine Injection 1 records · Latest accepted 2024/03/01

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2400743Generic2024/03/01Shandong 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

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2400454Generic2024/02/03Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
Macitentan Tablets 1 records · Latest accepted 2023/12/22

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2303558Generic2023/12/22Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
Baricitinib Tablets 1 records · Latest accepted 2023/09/13

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2302467Generic2023/09/13Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
Pirfenidone Tablets 1 records · Latest accepted 2023/04/01

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2300947Generic2023/04/01Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
Sildenafil Citrate Oral Disintegrating Tablets 1 records · Latest accepted 2023/03/02

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2300671Generic2023/03/02Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
孟鲁司特钠颗粒 · No verified English name 1 records · Latest accepted 2022/11/10

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2201928Generic2022/11/10Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
Rasagiline Mesylate Tablets 1 records · Latest accepted 2022/04/22

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2200628Generic2022/04/22Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
重酒石酸卡巴拉汀胶囊 · No verified English name 2 records · Latest accepted 2022/03/24

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2200482Generic2022/03/24Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2200481Generic2022/03/24Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanizedCDE ↗
Argatroban Injection 1 records · Latest accepted 2021/07/02

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2101381Generic2021/07/02Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanizedCDE ↗
Ornidazole Injection 1 records · Latest accepted 2021/06/21

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2101322Generic2021/06/21Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Tong Hua Jin Ma Pharma Group Co., Ltd. romanizedCDE ↗

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

  1. 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 ↗
  2. 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 ↗
  3. 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 ↗
  4. 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 ↗
  5. 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 ↗
  6. 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 ↗
  7. 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 ↗
  8. 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.

Under review
Drug Acceptance numberApplication typeAcceptedCompany / applicantView source
Dapoxetine Hydrochloride Tablets CYHB2600607Supplement2026/03/27Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanizedCDE ↗
利多卡因丙胺卡因气雾剂 · No verified English name CYHS2600308Generic2026/01/29Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Lu Nan Bei Te Pharmaceutical Co., Ltd. romanizedCDE ↗
盐酸毛果芸香碱滴眼液 · No verified English name CYHS2502428Generic2025/07/09Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Jin Yao Yong Guang (Hebei) Pharmaceutical Co., Ltd. romanizedCDE ↗
蒙脱石混悬液 · No verified English name CYHS2501498Generic2025/04/19Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanizedCDE ↗

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.

DrugMarketing authorization holderManufacturerApproval numberApprovedCatalogue category (source text)View source
Labetalol Hydrochloride TabletsShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedAnhui Tai En Kang Pharmaceutical Co., Ltd. romanized国药准字H202659792026/09/15Generic approved under the new chemical-drug registration classificationCDE ↗
Labetalol Hydrochloride TabletsShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedAnhui Tai En Kang Pharmaceutical Co., Ltd. romanized国药准字H202659802026/09/15Generic approved under the new chemical-drug registration classificationCDE ↗
Sodium sulfate, magnesium sulfate, and potassium chloride TabletsShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedAnhui Tai En Kang Pharmaceutical Co., Ltd. romanized国药准字H202649372026/06/23Generic approved under the new chemical-drug registration classificationCDE ↗
Macitentan TabletsShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedAnhui Tai En Kang Pharmaceutical Co., Ltd. romanized国药准字H202638012026/03/31Generic approved under the new chemical-drug registration classificationCDE ↗
Nimodipine InjectionShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedSichuan Kelun Pharmaceutical Co., Ltd.国药准字H202632492026/01/27Generic approved under the new chemical-drug registration classificationCDE ↗
Finasteride and Tadalafil CapsulesShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedAnhui Tai En Kang Pharmaceutical Co., Ltd. romanized国药准字H202563052025/12/16Generic approved under the new chemical-drug registration classificationCDE ↗
Thiamazole TabletsShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedAnhui Tai En Kang Pharmaceutical Co., Ltd. romanized国药准字H202560962025/12/03Not stated by sourceCDE ↗
Thiamazole TabletsShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedAnhui Tai En Kang Pharmaceutical Co., Ltd. romanized国药准字H202560952025/12/03Not stated by sourceCDE ↗
Baricitinib TabletsShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedAnhui Tai En Kang Pharmaceutical Co., Ltd. romanized国药准字H202560602025/11/25Generic approved under the new chemical-drug registration classificationCDE ↗
Alendronate Sodium TabletsShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedYan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H202548762025/07/15Generic approved under the new chemical-drug registration classificationCDE ↗
Rupatadine Fumarate TabletsShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedAnhui Tai En Kang Pharmaceutical Co., Ltd. romanized国药准字H202533302025/01/24Generic approved under the new chemical-drug registration classificationCDE ↗
Pramipexole Dihydrochloride Prolonged-release TabletsShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedYan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H202445432024/07/30Not stated by sourceCDE ↗
Pramipexole Dihydrochloride Prolonged-release TabletsShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedYan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H202445422024/07/30Generic approved under the new chemical-drug registration classificationCDE ↗
孟鲁司特钠颗粒 · No verified English nameShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedAnhui Tai En Kang Pharmaceutical Co., Ltd. romanized国药准字H202437542024/05/21Generic approved under the new chemical-drug registration classificationCDE ↗
Sildenafil Citrate Oral Disintegrating TabletsShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedAnhui Tai En Kang Pharmaceutical Co., Ltd. romanized国药准字H202436952024/05/15Generic approved under the new chemical-drug registration classificationCDE ↗
Rasagiline Mesylate TabletsShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedAnhui Tai En Kang Pharmaceutical Co., Ltd. romanized国药准字H202437002024/05/15Generic approved under the new chemical-drug registration classificationCDE ↗
重酒石酸卡巴拉汀胶囊 · No verified English nameShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedAnhui Tai En Kang Pharmaceutical Co., Ltd. romanized国药准字H202344972023/11/21Generic approved under the new chemical-drug registration classificationCDE ↗
重酒石酸卡巴拉汀胶囊 · No verified English nameShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedAnhui Tai En Kang Pharmaceutical Co., Ltd. romanized国药准字H202344982023/11/21Generic approved under the new chemical-drug registration classificationCDE ↗
Argatroban InjectionShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedYan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H202334712023/04/17Generic approved under the new chemical-drug registration classificationCDE ↗
Ornidazole InjectionShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedTong Hua Jin Ma Pharma Group Co., Ltd. romanized国药准字H202333742023/03/24Generic approved under the new chemical-drug registration classificationCDE ↗
Tadalafil TabletsShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedAnhui Tai En Kang Pharmaceutical Co., Ltd. romanized国药准字H202233992022/06/16Generic approved under the new chemical-drug registration classificationCDE ↗
Tadalafil TabletsShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedAnhui Tai En Kang Pharmaceutical Co., Ltd. romanized国药准字H202234002022/06/16Generic approved under the new chemical-drug registration classificationCDE ↗
Tadalafil TabletsShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedAnhui Tai En Kang Pharmaceutical Co., Ltd. romanized国药准字H202234012022/06/16Generic approved under the new chemical-drug registration classificationCDE ↗
Dapoxetine Hydrochloride TabletsShandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedYan Tai Lu Yin Pharma Co., Ltd. romanized国药准字H202031692020/04/14Generic approved under the new chemical-drug registration classificationCDE ↗

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.

NameCompany / applicantRegistration numberStatusSource update dateView 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.

Co-applicant records
Drug Acceptance numberApplication typeAcceptedCompany / applicantView source
过氧苯甲酰 · No verified English name JTH2500001Not stated by source2025/01/03CAMBREX KARLSKOGA AB; Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedCDE ↗
比拉斯汀 · No verified English name JTH2300114Not stated by source2023/05/07VIRUPAKSHA?ORGANICS?LIMITED UNIT-I; VIRUPAKSHA ORGANICS LIMITED UNIT-I; Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedCDE ↗
盐酸毛果芸香碱 · No verified English name JTH2200194Not stated by source2022/09/17Anidro do Brasil Extracoes S.A.; Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedCDE ↗
马昔腾坦 · No verified English name JTH2200103Not stated by source2022/06/03MSN LIFE SCIENCES PRIVATE LIMITED UNIT - II romanized; Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedCDE ↗
巴瑞替尼 · No verified English name JTH2200068Not stated by source2022/03/31Natco Pharma Limited; Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedCDE ↗
盐酸毛果芸香碱 · No verified English name JTH2200066Not stated by source2022/03/23Anidro do Brasil Extra??es S.A.; C-squared PHARMA S.a r.l.; Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedCDE ↗
巴瑞替尼 · No verified English name JTH2200044Not stated by source2022/03/04Natco Pharma Limited; Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedCDE ↗
米拉贝隆 · No verified English name JTH2200014Not stated by source2022/01/26Biocon Limited; Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedCDE ↗
米拉贝隆 · No verified English name JTH2100695Not stated by source2021/11/25LUPIN LIMITED; Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedCDE ↗
吡仑帕奈(3/4水合物) · No verified English name JTH2100553Not stated by source2021/06/25MSN Organics Private Limited; Shandong Hua Bo Kai Sheng Bio Technology Co., Ltd. romanizedCDE ↗

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.