Suppliers / W. R. Grace & Co.-Conn

W. R. Grace & Co.-Conn

United States Updated 9 July 2026

W. R. Grace & Co.-Conn is an API manufacturer based in United States. It holds 14 active US drug master files across a filed portfolio of 13 molecules. Its filings concentrate with EEC_EAEU and BRELA (TZ). Its GMP standing is certified by NAFDAC (NG) and US FDA. Its most recent recorded inspection, by US FDA, closed on 2 March 2026 as NAI.

14
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
3
filings across 2 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

  • 2 March 2026 NAI US FDA
  • 8 December 2017 NAI US FDA
  • 14 May 2014 NAI US FDA
  • 19 January 2012 NAI US FDA
  • 19 November 2010 NAI US FDA
  • 22 July 2009 NAI US FDA

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

Registered plants

Site FDA FEI
South Haven, United States 1826582

What they file, and where

Molecule Regulators Docs
Lidocaine US FDA 2
Benazepril US FDA 1
Benzonatate US FDA 1
Diphenhydramine US FDA 1
Fenoprofen US FDA 1
Itraconazole US FDA 1
Milrinone US FDA 1
Orphenadrine US FDA 1
Pramocaine US FDA 1
Procainamide US FDA 1
Show all 13 molecules on file
Propranolol US FDA 1
Terconazole US FDA 1
Tetracaine US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
EEC_EAEU 2 None
BRELA (TZ) 1 None
NAFDAC (NG) None 1
US FDA None 1

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Open risk flags

  • The most recent inspection outcome was NAI, on 2 March 2026.

Sources on this page

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