Suppliers / Ambiopharm

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.

4
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
0
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

Questions about Ambiopharm

Does Ambiopharm hold a US DMF or a CEP?
Ambiopharm holds 4 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Ambiopharm FDA-registered?
One site operated by Ambiopharm carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Ambiopharm's last inspection go?
The most recent inspection on record closed on 9 February 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Ambiopharm manufacture?
1 registered site is on record, in United States (North Augusta). Every site is listed on this page with the register it came from.
What does Ambiopharm make?
4 molecules are on record against Ambiopharm, including Bivalirudin, Eptifibatide, Glucagon and Octreotide. Each links through to that molecule's full manufacturer list.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

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

Comparable suppliers

Alp Pharm Beijing shares 3 molecules Sinopep-Allsino Biopharmaceutical shares 3 molecules Chengdu Shengnuo Biopharm shares 3 molecules Hainan Shuangcheng Pharmaceuticals shares 3 molecules ScinoPharm Taiwan shares 2 molecules

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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