Is Macfarlan Smith Limited FDA approved?

Macfarlan Smith Limited holds 1 FDA-registered establishment in the United Kingdom. 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 Macfarlan Smith Limited's drugs manufactured?

The FDA register lists Edinburgh. Registered operations: active ingredient (API) manufacture.

What drugs does Macfarlan Smith Limited make?

4 products are listed under Macfarlan Smith Limited in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Macfarlan Smith Limited

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

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Registered sites: 1
Active NDC listings: 4
Labeller names: 2
Live patents: 0
Countries: 1
Base: United Kingdom

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Macfarlan Smith Limited	10 Wheatfield Road, Edinburgh, Midlothian EH11 2QA, United Kingdom (GBR)	Active ingredient (API) manufacture	3002807530214057671

Catalogue

Drug listings by form and route

4 active NDC listings: 4 bulk ingredient. By marketing category: BULK INGREDIENT 2, BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 2.

Dosage form	NDCs
powder	4

Route	NDCs

Labeller name on the listing	NDCs
macfarlan smith limited	3
macfarlan smith limited	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Apomorphine Hydrochloride	powder	12707-031BULK INGREDIENT
-	Buprenorphine	powder	12707-036BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	Buprenorphine Hydrochloride	powder	12707-035BULK INGREDIENT
-	Naloxone Hydrochloride Dihydrate	powder	12707-037BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

Neighbours

Registered in the same town

Catalent Pharma Solutions Inc.Edinburgh, GBR

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Enquiry

Common questions

Is Macfarlan Smith Limited FDA approved?: Macfarlan Smith Limited holds 1 FDA-registered establishment in the United Kingdom. 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 Macfarlan Smith Limited's drugs manufactured?: The FDA register lists Edinburgh. Registered operations: active ingredient (API) manufacture.
What drugs does Macfarlan Smith Limited make?: 4 products are listed under Macfarlan Smith Limited in the openFDA NDC Directory, most often as powder. 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.