Suppliers / SI Group

SI Group

United States 2 duplicate records merged Updated 9 July 2026

SI Group is an API manufacturer based in United States. It holds 2 active US drug master files and 2 valid CEPs across a filed portfolio of 2 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 17 January 2025 as VAI.

2
active US DMFs
2
valid CEPs
2
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
3 of 3 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 17 January 2025 VAI US FDA
  • 18 June 2015 NAI US FDA
  • 24 September 2010 NAI US FDA

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

Registered plants

Site FDA FEI
The Woodlands, United States Not on file
Orangeburg, United States 3011012288

What they file, and where

Molecule Regulators Docs
Propofol EDQM, SFDA (Saudi Arabia), US FDA 3
Ibuprofen EDQM, US FDA 2

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

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Open risk flags

  • The most recent inspection outcome was VAI, on 17 January 2025.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates