Zhi En Bio Technology Co., Ltd. romanized

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.

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: 2 applicationsAccepted: 2 applicationsNotification delivery: 1 application

1. 2026/11/03Marketing application approved

   Voriconazole Tablets

   CYHS2502561 · 国药准字H20266476

   Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06

   View source · Table row 97 ↗
2. 2026/11/03Marketing application approved

   Voriconazole Tablets

   CYHS2502560 · 国药准字H20266475

   Fact date: 2026/11/03 · Publication date: 2026/11/05 · Site observation date: 2026/11/06

   View source · Table row 96 ↗
3. 2026/10/28Notification delivery

   Dapoxetine Hydrochloride Tablets

   CYHS2602001

   Fact date: 2026/10/28 (Publication date) · Publication date: 2026/10/28 · Site observation date: 2026/11/03

   Notification delivered; the specific outcome remains to be checked.

   View source · Table row 23 ↗
4. 2026/08/25Accepted

   琥珀酸地文拉法辛缓释片 · No verified English name

   CYHS2602120

   Fact date: 2026/08/25 · Site observation date: 2026/10/22

   View source ↗
5. 2026/08/25Accepted

   琥珀酸地文拉法辛缓释片 · No verified English name

   CYHS2602119

   Fact date: 2026/08/25 · Site observation date: 2026/10/22

   View source ↗

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.

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.

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.

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.

Public drug landscapes ↗