Is Dalton Chemical Laboratories Inc FDA approved?

Dalton Chemical Laboratories Inc holds 1 FDA-registered establishment in Canada. 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 Dalton Chemical Laboratories Inc's drugs manufactured?

The FDA register lists Toronto. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture, packaging, sterilize.

What drugs does Dalton Chemical Laboratories Inc make?

2 products are listed under Dalton Chemical Laboratories Inc in the openFDA NDC Directory, most often as injection, powder, for solution; solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Dalton Chemical Laboratories Inc

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

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Registered sites: 1
Active NDC listings: 2
Live patents: 0
Countries: 1
Base: Canada

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Finished drug manufacture1Packaging1sterilize1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Dalton Chemical Laboratories Inc	349 Wildcat Road, Toronto, Ontario M3J 2S3, Canada (CAN)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture, Packaging, sterilize	3003094018248310666

Catalogue

Drug listings by form and route

2 active NDC listings: 2 drug for further processing. By marketing category: DRUG FOR FURTHER PROCESSING 2.

Dosage form	NDCs
injection, powder, for solution	1
solution	1

Route	NDCs

Labeller name on the listing	NDCs
dalton chemical laboratories inc.	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Phosphate Buffer Solution	solution	81260-002DRUG FOR FURTHER PROCESSING
-	Sterile Micronized Artesunate	injection, powder, for solution	81260-001DRUG FOR FURTHER PROCESSING

Neighbours

Registered in the same town

Apotex Inc.Toronto, CAN
Deciem IncToronto, CAN
Derma Sciences Canada IncToronto, CAN

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Enquiry

Common questions

Is Dalton Chemical Laboratories Inc FDA approved?: Dalton Chemical Laboratories Inc holds 1 FDA-registered establishment in Canada. 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 Dalton Chemical Laboratories Inc's drugs manufactured?: The FDA register lists Toronto. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture, packaging, sterilize.
What drugs does Dalton Chemical Laboratories Inc make?: 2 products are listed under Dalton Chemical Laboratories Inc in the openFDA NDC Directory, most often as injection, powder, for solution; solution. 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.