Hunan Ke Lun Pharmaceutical 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: 1 applicationAccepted: 4 applicationsNo longer listed under review: 1 applicationSupplement delivery: 3 applications

1. 2026/11/11No longer listed under review

   Lactulose Oral Solution

   CYHB2600092

   Fact date: 2026/11/11 · Site observation date: 2026/11/11

   Accepted: 2026/01/17

   not on the CDE under-review list in this snapshot; NMPA published approval-document delivery for this acceptance number on 2026/11/10 (approval no.: —; approval date: 2026/11/09); this is a supplemental application, not counted as a new marketing approval · NMPA source · row 10

   NMPA · Table row 10 ↗ View source ↗
2. 2026/11/09Supplement delivery

   Lactulose Oral Solution

   CYHB2600092

   Fact date: 2026/11/09 · Publication date: 2026/11/10 · Site observation date: 2026/11/10

   Supplemental application; excluded from new marketing approvals.

   View source · Table row 10 ↗
3. 2026/11/03Marketing application approved

   Perampanel oral suspension

   CYHS2501783 · 国药准字H20266516

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

   View source · Table row 74 ↗
4. 2026/10/27Accepted

   Ruxolitinib Phosphate Tablets

   CYHS2602630

   Fact date: 2026/10/27 · Site observation date: 2026/10/28

   View source ↗
5. 2026/10/23Accepted

   瑞维那新吸入溶液 · No verified English name

   CYHB2601947

   Fact date: 2026/10/23 · Site observation date: 2026/10/24

   View source ↗
6. 2026/10/21Accepted

   Bupivacaine Hydrochloride Injection

   CYHB2601926

   Fact date: 2026/10/21 · Site observation date: 2026/10/22

   View source ↗
7. 2026/10/16Supplement delivery

   Erythromycin Lactobionate for Injection

   CYHB2550288 · 国药准字H20269253

   Fact date: 2026/10/16 · Publication date: 2026/10/21 · Site observation date: 2026/11/03

   Supplemental application; excluded from new marketing approvals.

   View source · Table row 3 ↗
8. 2026/10/16Supplement delivery

   Erythromycin Lactobionate for Injection

   CYHB2550287

   Fact date: 2026/10/16 · Publication date: 2026/10/21 · Site observation date: 2026/11/03

   Supplemental application; excluded from new marketing approvals.

   View source · Table row 2 ↗
9. 2026/10/10Accepted

   氯化钠注射液 · No verified English name

   CYHB2601856

   Fact date: 2026/10/10 · Site observation date: 2026/10/21

   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 ↗