Is W. R. GRACE & CO.-CONN. FDA approved?

W. R. GRACE & CO.-CONN. holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are W. R. GRACE & CO.-CONN.'s drugs manufactured?

The FDA register lists South Haven, MI. Registered operations: active ingredient (API) manufacture.

What drugs does W. R. GRACE & CO.-CONN. make?

22 products are listed under W. R. GRACE & CO.-CONN. in the openFDA NDC Directory, most often as powder; liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

W. R. GRACE & CO.-CONN.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 22
Labeller names: 2
Live patents: 0
Countries: 1
Base: United States

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
W. R. Grace & Co.-Conn.Registrant: W. R. GRACE & CO.-CONN.	1421 Kalamazoo St, South Haven, Michigan (MI) 49090-1945, United States (USA)	Active ingredient (API) manufacture	1826582788779192

Catalogue

Drug listings by form and route

22 active NDC listings: 22 bulk ingredient. By marketing category: BULK INGREDIENT 22.

Dosage form	NDCs
powder	21
liquid	1

Route	NDCs

Labeller name on the listing	NDCs
w. r. grace & co.-conn.	13
w. r. grace & co.-conn.	9

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Amifostine	powder	22568-8865BULK INGREDIENT
-	Benazepril Hydrochloride	powder	22568-1136BULK INGREDIENT
-	Benzonatate	liquid	22568-1005BULK INGREDIENT
-	Diphenhydramine Citrate	powder	22568-1001BULK INGREDIENT
-	Ecopipam Hydrochloride	powder	22568-0442BULK INGREDIENT
-	Fenoprofen Calcium	powder	22568-1157BULK INGREDIENT
-	Itraconazole	powder	22568-1108BULK INGREDIENT
-	Larotrectinib Sulfate	powder	22568-1752BULK INGREDIENT
-	Lidocaine	powder	22568-1014BULK INGREDIENT
-	Lidocaine Hydrochloride	powder	22568-1082BULK INGREDIENT
-	Lidocaine Tetracaine Hydrochloride	powder	22568-1029BULK INGREDIENT
-	Meclofenamate Sodium	powder	22568-1018BULK INGREDIENT
-	Methenamine Mandelate	powder	22568-1968BULK INGREDIENT
-	Milrinone	powder	22568-1127BULK INGREDIENT
-	Orphenadrine Citrate	powder	22568-1022BULK INGREDIENT
-	Pramoxine Hydrochloride	powder	22568-1076BULK INGREDIENT
-	Procainamide HCl	powder	22568-1026BULK INGREDIENT
-	Propranolol Hydrochloride	powder	22568-1027BULK INGREDIENT
-	Tecovirimat Monohydrate	powder	22568-8724BULK INGREDIENT
-	Terconazole	powder	22568-1125BULK INGREDIENT
-	Tetrahydrozoline Hydrochloride	powder	22568-1132BULK INGREDIENT
-	para- Aminohippuric Acid	powder	22568-1010BULK INGREDIENT

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Enquiry

Common questions

Is W. R. GRACE & CO.-CONN. FDA approved?: W. R. GRACE & CO.-CONN. holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are W. R. GRACE & CO.-CONN.'s drugs manufactured?: The FDA register lists South Haven, MI. Registered operations: active ingredient (API) manufacture.
What drugs does W. R. GRACE & CO.-CONN. make?: 22 products are listed under W. R. GRACE & CO.-CONN. in the openFDA NDC Directory, most often as powder; liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.