Suppliers / Sterling Wisconsin

Sterling Wisconsin

United States Updated 9 July 2026

Sterling Wisconsin is an API manufacturer based in United States. It holds 5 active US drug master files across a filed portfolio of 5 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 12 March 2024 as NAI.

5
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
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 12 March 2024 NAI US FDA
  • 24 June 2016 NAI US FDA
  • 18 September 2013 VAI US FDA
  • 16 December 2011 VAI US FDA
  • 4 August 2009 VAI US FDA

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

Registered plants

Site FDA FEI
Germantown, United States 3004485164

What they file, and where

Molecule Regulators Docs
Dexmedetomidine US FDA 1
Dexrazoxane US FDA 1
Isoprenaline US FDA 1
Isradipine US FDA 1
Midodrine US FDA 1

Also appears on these molecule pages

Dexmedetomidine API Dexrazoxane API Isoprenaline API Isradipine API Midodrine API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Sterling Wisconsin

Does Sterling Wisconsin hold a US DMF or a CEP?
Sterling Wisconsin holds 5 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 Sterling Wisconsin FDA-registered?
One site operated by Sterling Wisconsin 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 Sterling Wisconsin's last inspection go?
The most recent inspection on record closed on 12 March 2024 as NAI (No Action Indicated: nothing objectionable was found). 5 inspections are on file.
Where does Sterling Wisconsin manufacture?
1 registered site is on record, in United States (Germantown). Every site is listed on this page with the register it came from.
What does Sterling Wisconsin make?
5 molecules are on record against Sterling Wisconsin, including Dexmedetomidine, Dexrazoxane, Isoprenaline and Isradipine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Sterling Wisconsin'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. Sterling Wisconsin 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 NAI, on 12 March 2024.

Comparable suppliers

Gland Pharma shares 3 molecules Edmond Pharma shares 3 molecules Apitoria Pharma shares 2 molecules Yangtze River Pharmaceutical Group Jiangsu Haici Biological shares 2 molecules MSN Laboratories 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