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 US FDA and NAFDAC (NG). 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

Benazepril API Diphenhydramine API Itraconazole API Lidocaine API Milrinone API Pramocaine API Propranolol API Tetracaine API

Filings and GMP by regulator

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

Questions about W. R. Grace & Co.-Conn

Does W. R. Grace & Co.-Conn hold a US DMF or a CEP?
W. R. Grace & Co.-Conn holds 14 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 W. R. Grace & Co.-Conn FDA-registered?
One site operated by W. R. Grace & Co.-Conn 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 W. R. Grace & Co.-Conn's last inspection go?
The most recent inspection on record closed on 2 March 2026 as NAI (No Action Indicated: nothing objectionable was found). 6 inspections are on file.
Where does W. R. Grace & Co.-Conn manufacture?
1 registered site is on record, in United States (South Haven). Every site is listed on this page with the register it came from.
What does W. R. Grace & Co.-Conn make?
13 molecules are on record against W. R. Grace & Co.-Conn, including Lidocaine, Benazepril, Benzonatate and Diphenhydramine. Each links through to that molecule's full manufacturer list.
Which regulators recognise W. R. Grace & Co.-Conn's GMP?
Current GMP certificates are on record from US FDA and NAFDAC (NG). 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.

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Open risk flags

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

Comparable suppliers

Alivus Life Sciences shares 2 molecules Farmhispania shares 2 molecules Shandong Chenghui Shuangda Pharmaceutical shares 2 molecules Apitoria Pharma shares 1 molecule Matrix Pharmacorp 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