Hetero Labs Limited

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 2026/11/10 18:31; 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: 1 application

1. 2026/10/30No longer listed under review

   Lamivudine and Dolutegravir Sodium Tablets

   JYHS2500044

   Fact date: 2026/10/30 · Site observation date: 2026/10/30

   Accepted: 2025/10/31

   not on the CDE under-review list in this snapshot; the review / approval outcome is to be checked

   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: 2026/11/11 06:42

Chemical-drug catalogue

Last successful update: 2026/11/11 06:38

Full API register

Last successful update: 2026/11/11 06:40

NMPA drug delivery notices

Last successful update: 2026/11/10 18:31 · Current coverage may be incomplete

First index-page publication dates: — to —; 0 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.

Drug names use verified official English names only. Missing names are shown as No verified English name, linking to a Chinese page. Company labels use verified official names, Latin source names, then fixed-rule transliterations marked romanized. Original statutory reference numbers are the sole visible Chinese exception.

Legal reference identifiers are retained verbatim. Company labels use official English entries where available, or a visibly marked fixed romanization. Chinese free text is not displayed; use the source links or source-name columns in CSV exports.

Public drug landscapes ↗