Is Niagara Pharmaceuticals Inc. FDA approved?

Niagara Pharmaceuticals Inc. holds 2 FDA-registered establishments across 2 countries. 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 Niagara Pharmaceuticals Inc.'s drugs manufactured?

At registered sites in Canada, the United States. The FDA register lists Dundas; Cowpens, SC. Registered operations: active ingredient (API) manufacture, finished drug manufacture.

What drugs does Niagara Pharmaceuticals Inc. make?

7 products are listed under Niagara Pharmaceuticals Inc. in the openFDA NDC Directory, most often as solution; liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Niagara Pharmaceuticals Inc.

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

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Registered sites: 2
Active NDC listings: 7
Labeller names: 2
Live patents: 0
Countries: 2
Base: United States

Authorisation

Registered operations

Active ingredient (API) manufacture1Finished drug manufacture2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Niagara Pharmaceuticals, IncRegistrant: Niagara Pharmaceuticals Inc.	60 Innovation Drive, Dundas, Ontario L9H7P3, Canada (CAN)	Active ingredient (API) manufacture, Finished drug manufacture	3003093882205477792
Niagara Pharmaceuticals LLCRegistrant: Niagara Pharmaceuticals Inc.	1290 Mount Olive Rd, Cowpens, South Carolina (SC) 29330-9452, United States (USA)	Finished drug manufacture	3036791147119505161

Catalogue

Drug listings by form and route

7 active NDC listings: 7 human otc drug. By marketing category: NDA 6, OTC MONOGRAPH DRUG 1.

Dosage form	NDCs
solution	6
liquid	1

Route	NDCs
ophthalmic	7

Labeller name on the listing	NDCs
niagara pharmaceuticals inc.	6
niagara pharmaceuticals, inc.	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Eyewash Station Additive Concentrate	Chlorhexidine gluconate and Propylene Glycol	liquid, ophthalmic	65785-034OTC MONOGRAPH DRUG
PUR-WASH	Water	solution, ophthalmic	65785-160NDA
PUR-WASH	Water	solution, ophthalmic	65785-162NDA
PUR-WASH	Water	solution, ophthalmic	65785-166NDA
PUR-WASH	Water	solution, ophthalmic	65785-169NDA
Pur-Wash	Eyewash	solution, ophthalmic	65785-168NDA
ULINE Eyewash	Eyewash	solution, ophthalmic	65785-125NDA

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Enquiry

Common questions

Is Niagara Pharmaceuticals Inc. FDA approved?: Niagara Pharmaceuticals Inc. holds 2 FDA-registered establishments across 2 countries. 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 Niagara Pharmaceuticals Inc.'s drugs manufactured?: At registered sites in Canada, the United States. The FDA register lists Dundas; Cowpens, SC. Registered operations: active ingredient (API) manufacture, finished drug manufacture.
What drugs does Niagara Pharmaceuticals Inc. make?: 7 products are listed under Niagara Pharmaceuticals Inc. in the openFDA NDC Directory, most often as solution; 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.