Hanlim Pharm. Co., Ltd.
Yongin, Korea (the Republic of)
Works in Cardiovascular · Dermatology · GI & liver · Metabolic & endocrine · Ophthalmology · Respiratory
Hanlim Pharm. Co., Ltd. is a clinical trial sponsor based in Yongin, Korea (the Republic of). It has 1 active clinical trial with 228 planned participants, across 6 therapeutic areas. Since 2021 it has completed 6 trials and stopped 0 early. Its FDA record on file shows 2 inspections and 1 warning letter.
Trial track record · since 2021
FDA record
Recent FDA actions
Pipeline · 1 active trial
| Stage | Trial | Status |
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Questions about Hanlim Pharm. Co., Ltd
Yes. FDA has published 1 warning letter naming Hanlim Pharm. Co., Ltd; the latest was posted on 2026-10-13. Each letter links to FDA's own posting.
FDA has posted 2 inspection classifications naming Hanlim Pharm. Co., Ltd (1 NAI, 1 OAI). The latest inspection ended on 2026-04-24 and was classified OAI (official action indicated). FDA posts a classification after its review, often months after the inspection ended.
Hanlim Pharm. Co., Ltd is lead sponsor of 1 active clinical trial on ClinicalTrials.gov, with 228 planned participants, in Cardiovascular, Dermatology, GI & liver, Metabolic & endocrine and other areas. Since 2021 it has completed 6 trials and stopped 0 early.
Hanlim Pharm. Co., Ltd is based in Yongin, Korea (the Republic of). The address is the one on its FDA records or ClinicalTrials.gov registrations, which name the establishment or the registrant, not always the group's head office.
From public sources only: ClinicalTrials.gov for trials, FDA's Data Dashboard, warning-letter listing and enforcement reports for the FDA record, and SEC filings for financials. Approve Suite is not affiliated with Hanlim Pharm. Co., Ltd; every record links to the source, and nothing here is advice.
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Trial counts are as the sponsor reported them to ClinicalTrials.gov, for trials changed since 2021; latest update 2026-05-20.
The FDA record counts inspection classifications, warning letters and recalls FDA has published that name this company. Compare it with the industry in the free CDMO FDA inspection lookup.
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