Ambiopharm

United States Updated 9 July 2026

Ambiopharm is an API manufacturer based in United States. It holds 4 active US drug master files across a filed portfolio of 4 molecules. Its most recent recorded inspection, by US FDA, closed on 9 February 2023 as VAI.

active US DMFs

valid CEPs

registered plants 1 with an FDA FEI number

filings across 0 regulators

These figures were checked against the regulators' own files on 25 July 2026

Plants

1 of 1 confirmed

Inspections

6 of 6 confirmed

Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

9 February 2023 VAI US FDA
5 July 2017 VAI US FDA
9 October 2014 VAI US FDA
28 March 2013 VAI US FDA
16 August 2011 NAI US FDA
4 November 2008 NAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site	FDA FEI
North Augusta, United States	3006446551

What they file, and where

Molecule	Regulators	Docs
Bivalirudin	US FDA	1
Eptifibatide	US FDA	1
Glucagon	US FDA	1
Octreotide	US FDA	1

Also appears on these molecule pages

Bivalirudin API Eptifibatide API Octreotide API

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Open risk flags

The most recent inspection outcome was VAI, on 9 February 2023.

Sources on this page

FDA: Drug master files, establishment registration, inspection classifications
EDQM: Certificates of suitability