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

Ibuprofen API Propofol API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about SI Group

Does SI Group hold a US DMF or a CEP?
SI Group holds 2 active US drug master files and 2 valid CEPs. 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 SI Group FDA-registered?
One site operated by SI Group 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 SI Group's last inspection go?
The most recent inspection on record closed on 17 January 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does SI Group manufacture?
2 registered sites are on record, in United States (The Woodlands and Orangeburg). Every site is listed on this page with the register it came from.
What does SI Group make?
2 molecules are on record against SI Group, including Propofol and Ibuprofen. Each links through to that molecule's full manufacturer list.
Which regulators recognise SI Group's GMP?
Current GMP certificates are on record from US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

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.

Comparing suppliers?

Choose your molecules and target markets. SI Group comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

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

Comparable suppliers

Neuland Laboratories shares 1 molecule Curia shares 1 molecule Solara Active Pharma Sciences shares 1 molecule Piramal Pharma shares 1 molecule SMS Pharmaceuticals shares 1 molecule

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
EudraGMDP and national regulators
GMP certificates