Is Olpha AS FDA approved?

Olpha AS holds 1 FDA-registered establishment in Latvia. 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 Olpha AS's drugs manufactured?

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

What drugs does Olpha AS make?

8 products are listed under Olpha AS 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.

Olpha AS

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

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Registered sites: 1
Active NDC listings: 8
Live patents: 0
Countries: 1
Base: Latvia

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Olpha AS	5 Rupnicu iela, Olaine, Olaines novads, LV-2114, Latvia (LVA)	Active ingredient (API) manufacture	3001672072644699498

Catalogue

Drug listings by form and route

8 active NDC listings: 8 bulk ingredient. By marketing category: BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 6, BULK INGREDIENT 2.

Dosage form	NDCs
powder	8

Route	NDCs

Labeller name on the listing	NDCs
olpha as	8

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	AMANTADINE HYDROCHLORIDE	powder	63818-0435BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	ARBACLOFEN	powder	63818-0001BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	ARBACLOFEN	powder	63818-0002BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	Anagrelide Hydrochloride	powder	63818-0425BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	CHLOROBUTANOL HEMIHYDRATE	powder	63818-0005BULK INGREDIENT
-	Memantine Hydrochloride	powder	63818-0004BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	Rimantadine Hydrochloride	powder	63818-0434BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	THALIDOMIDE	powder	63818-0424BULK INGREDIENT

Enquiry

Common questions

Is Olpha AS FDA approved?: Olpha AS holds 1 FDA-registered establishment in Latvia. 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 Olpha AS's drugs manufactured?: The FDA register lists Olaines novads. Registered operations: active ingredient (API) manufacture.
What drugs does Olpha AS make?: 8 products are listed under Olpha AS 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.