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Company directoryChina company filings

Anhui Bei Ke Biopharmaceutical 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 47444db717

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

25 acceptance records as first applicant, grouped into 19 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.

Emtricitabine and Tenofovir Alafenamide Fumarate Tablets(Ⅱ) 1 records · Latest accepted 2026/08/03

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2601872Generic2026/08/03Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
Baricitinib Tablets 2 records · Latest accepted 2026/07/20

Generic · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2601730Generic2026/07/20Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2601729Generic2026/07/20Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
Oseltamivir Phosphate Capsules 2 records · Latest accepted 2026/05/07

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2600862Supplement2026/05/07Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2302524Supplement2023/11/15Anhui Bei Ke Biopharmaceutical Co., Ltd. romanized; Jiangsu Di Sai Nuo Pharmaceutical Co., Ltd. romanizedCDE ↗
Iguratimod Tablets 1 records · Latest accepted 2026/01/15

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2600186Generic2026/01/15Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
Dolutegravir Sodium Tablets 1 records · Latest accepted 2025/05/15

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2501764Generic2025/05/15Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
Lopinavir and Ritonavir Tablets 2 records · Latest accepted 2025/01/03

Supplement · 1Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2500012Supplement2025/01/03Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2200758Generic2022/05/25Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
Vardenafil Hydrochloride Orally disintegrating Tablets 1 records · Latest accepted 2024/09/10

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2402990Generic2024/09/10Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
Tenofovir Disoproxil Fumarate Tablets 1 records · Latest accepted 2024/07/29

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2401126Supplement2024/07/29Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
依非米替片(I) · No verified English name 1 records · Latest accepted 2024/04/08

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2401026Generic2024/04/08Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
Levodopa and Benserazide Hydrochloride Tablets 1 records · Latest accepted 2024/02/01

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2400418Generic2024/02/01Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
Emtricitabine and tenofovir disoproxil fumarate tablets 1 records · Latest accepted 2023/08/29

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2301944Supplement2023/08/29Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
Tadalafil Tablets 3 records · Latest accepted 2023/06/28

Generic · 3

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2301709Generic2023/06/28Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2301708Generic2023/06/28Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
CYHS2300404Generic2023/02/09Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
Rilpivirine Hydrochloride Tablets 1 records · Latest accepted 2023/05/18

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2301347Generic2023/05/18Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
Zidovudine And Lamivudine Tablets 1 records · Latest accepted 2023/05/10

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2350429Supplement2023/05/10Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
Zidovudine Tablets 1 records · Latest accepted 2023/04/01

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2350312Supplement2023/04/01Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
Ritonavir Tablets 1 records · Latest accepted 2022/11/22

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2202028Generic2022/11/22Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
Selegiline Hydrochloride Tablets 1 records · Latest accepted 2022/08/04

Generic · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHS2201236Generic2022/08/04Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
Efavirenz Tablets 2 records · Latest accepted 2022/07/02

Supplement · 2

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2250411Supplement2022/07/02Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
CYHB2250322Supplement2022/06/09Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
Metronidazole Tablets 1 records · Latest accepted 2021/08/26

Supplement · 1

Drug filings
Acceptance numberApplication typeAcceptedCompany / applicantView source
CYHB2101734Supplement2021/08/26Anhui Bei Ke Biopharmaceutical Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanizedCDE ↗

Changes in the last 90 days

1 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.

Marketing application approved: 1 application

  1. 2026/10/20Marketing application approved

    Dolutegravir Sodium Tablets

    CYHS2501764 · 国药准字H20266322

    Fact date: 2026/10/20 · Publication date: 2026/10/22 · Site observation date: 2026/11/03

    View source · Table row 65 ↗

Under review

5 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
Emtricitabine and Tenofovir Alafenamide Fumarate Tablets(Ⅱ) CYHS2601872Generic2026/08/03Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
Baricitinib Tablets CYHS2601730Generic2026/07/20Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
Baricitinib Tablets CYHS2601729Generic2026/07/20Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
Oseltamivir Phosphate Capsules CYHB2600862Supplement2026/05/07Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
Iguratimod Tablets CYHS2600186Generic2026/01/15Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗

Catalogue holder records

16 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
Lopinavir and Ritonavir TabletsAnhui Bei Ke Biopharmaceutical Co., Ltd. romanizedAnhui Bei Ke Biopharmaceutical Co., Ltd. romanized国药准字H202691152026/05/15Generic approved under the new chemical-drug registration classificationCDE ↗
Vardenafil Hydrochloride Orally disintegrating TabletsAnhui Bei Ke Biopharmaceutical Co., Ltd. romanizedAnhui Bei Ke Biopharmaceutical Co., Ltd. romanized国药准字H202639452026/04/14Generic approved under the new chemical-drug registration classificationCDE ↗
依非米替片(I) · No verified English nameAnhui Bei Ke Biopharmaceutical Co., Ltd. romanizedAnhui Bei Ke Biopharmaceutical Co., Ltd. romanized国药准字 H202545362025/06/10Generic approved under the new chemical-drug registration classificationCDE ↗
Levodopa and Benserazide Hydrochloride TabletsAnhui Bei Ke Biopharmaceutical Co., Ltd. romanizedAnhui Bei Ke Biopharmaceutical Co., Ltd. romanized国药准字H202540602025/04/30Generic approved under the new chemical-drug registration classificationCDE ↗
Tadalafil TabletsAnhui Bei Ke Biopharmaceutical Co., Ltd. romanizedAnhui Bei Ke Biopharmaceutical Co., Ltd. romanized国药准字H202490612024/10/16Generic approved under the new chemical-drug registration classificationCDE ↗
Tadalafil TabletsAnhui Bei Ke Biopharmaceutical Co., Ltd. romanizedAnhui Bei Ke Biopharmaceutical Co., Ltd. romanized国药准字H202490602024/10/16Generic approved under the new chemical-drug registration classificationCDE ↗
Rilpivirine Hydrochloride TabletsAnhui Bei Ke Biopharmaceutical Co., Ltd. romanizedAnhui Bei Ke Biopharmaceutical Co., Ltd. romanized国药准字H202448292024/09/03Generic approved under the new chemical-drug registration classificationCDE ↗
Tadalafil TabletsAnhui Bei Ke Biopharmaceutical Co., Ltd. romanizedAnhui Bei Ke Biopharmaceutical Co., Ltd. romanized国药准字H202436452024/04/30Generic approved under the new chemical-drug registration classificationCDE ↗
Ritonavir TabletsAnhui Bei Ke Biopharmaceutical Co., Ltd. romanizedAnhui Bei Ke Biopharmaceutical Co., Ltd. romanized国药准字H202433982024/03/29Generic approved under the new chemical-drug registration classificationCDE ↗
Zidovudine And Lamivudine TabletsAnhui Bei Ke Biopharmaceutical Co., Ltd. romanizedAnhui Bei Ke Biopharmaceutical Co., Ltd. romanized国药准字H201131292024/02/05Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Selegiline Hydrochloride TabletsAnhui Bei Ke Biopharmaceutical Co., Ltd. romanizedAnhui Bei Ke Biopharmaceutical Co., Ltd. romanized国药准字H202347212023/12/29Generic approved under the new chemical-drug registration classificationCDE ↗
Lopinavir and Ritonavir TabletsAnhui Bei Ke Biopharmaceutical Co., Ltd. romanizedAnhui Bei Ke Biopharmaceutical Co., Ltd. romanized国药准字H202340402023/08/08Generic approved under the new chemical-drug registration classificationCDE ↗
Efavirenz TabletsAnhui Bei Ke Biopharmaceutical Co., Ltd. romanizedAnhui Bei Ke Biopharmaceutical Co., Ltd. romanized国药准字H201931322023/05/29Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Efavirenz TabletsAnhui Bei Ke Biopharmaceutical Co., Ltd. romanizedAnhui Bei Ke Biopharmaceutical Co., Ltd. romanized国药准字H202370582023/05/24Drug that passed quality-and-efficacy consistency evaluationCDE ↗
Emtricitabine and tenofovir disoproxil fumarate tabletsAnhui Bei Ke Biopharmaceutical Co., Ltd. romanizedAnhui Bei Ke Biopharmaceutical Co., Ltd. romanized国药准字H202035392020/10/27Generic approved under the new chemical-drug registration classificationCDE ↗
Dolutegravir Sodium TabletsAnhui Bei Ke Biopharmaceutical Co., Ltd. romanizedAnhui Bei Ke Biopharmaceutical Co., Ltd. romanized国药准字H202663222026/10/20Generic 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

2 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
Levodopa and Benserazide Hydrochloride Tablets CYHB2501116Supplement2025/05/31Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized; Anhui Bei Ke Biopharmaceutical Co., Ltd. romanizedCDE ↗
Levodopa and Benserazide Hydrochloride Tablets CYHS2402185Generic2024/07/16Anhui Wan Bang Pharmaceuticals Technology Co., Ltd. romanized; Anhui Bei Ke Biopharmaceutical 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.