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Facility profile

Amphastar Nanjing Pharmaceuticals

Testing & analysis · Active pharmaceutical ingredient (API) manufacturing · Jiangsu 210038 · China

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed
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Listed operations

The U.S. Food and Drug Administration (FDA) record lists broad activities for this site. Confirm specific services and availability directly.

AnalysisActive pharmaceutical ingredient (API) manufacture
Due diligence

Regulatory record at a glance

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Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
No action indicated (NAI)

Mar 7, 2025 · No conditions warranted FDA action in this inspection.

Matched compliance actions
None in our records

No warning letter, injunction, or seizure matched.

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Shows

Registration status and a latest matched no action indicated inspection.

Doesn’t show

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Method and source details
View full inspection and compliance history5 inspection records

FDA inspection history

5 records, Apr 2014 – Mar 2025 · 3 NAI · 2 VAI · 0 OAI

DateClassProject areaCitationsFY
Mar 7, 2025NAIDrug Quality Assurance2025
Oct 11, 2019VAIDrug Quality Assurance2020
Oct 26, 2017NAIDrug Quality Assurance2018
Apr 29, 2016NAIDrug Quality Assurance2016
Apr 4, 2014VAIDrug Quality Assurance2014

No action indicated (NAI) · Voluntary action indicated (VAI) · Official action indicated (OAI)

Matched compliance actions

No warning letter, injunction, or seizure is matched in the current data set.

Unclaimed profile

Service details not yet provided

Methods, equipment, quality scope, capacity, turnaround, and commercial contacts are not available.

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