Is BIOTIKA a.s. FDA approved?

BIOTIKA a.s. holds 1 FDA-registered establishment in Slovakia. 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 BIOTIKA a.s.'s drugs manufactured?

The FDA register lists Slovensk� Lupca. Registered operations: active ingredient (API) manufacture.

What drugs does BIOTIKA a.s. make?

2 products are listed under BIOTIKA a.s. 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.

BIOTIKA a.s.

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: Slovakia

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
BIOTIKA a.s.	566, Slovensk� Lupca, 976 13, Slovakia (SVK)	Active ingredient (API) manufacture	3003370212643309776

Catalogue

Drug listings by form and route

2 active NDC listings: 2 bulk ingredient. By marketing category: BULK INGREDIENT 2.

Dosage form	NDCs
powder	2

Route	NDCs

Labeller name on the listing	NDCs
biotika a.s.	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Penicillin V Potassium	powder	54563-002BULK INGREDIENT
-	Polymyxin B Sulfate	powder	54563-008BULK INGREDIENT

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Comparable companies in Slovakia

Saneca Pharmaceuticals a.s.1 site · 6 NDC
hameln rds s.r.o.1 site · 2 NDC

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Common questions

Is BIOTIKA a.s. FDA approved?: BIOTIKA a.s. holds 1 FDA-registered establishment in Slovakia. 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 BIOTIKA a.s.'s drugs manufactured?: The FDA register lists Slovensk� Lupca. Registered operations: active ingredient (API) manufacture.
What drugs does BIOTIKA a.s. make?: 2 products are listed under BIOTIKA a.s. 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.