Is MIKROCHEM spol s ro FDA approved?

MIKROCHEM spol s ro 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 MIKROCHEM spol s ro's drugs manufactured?

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

MIKROCHEM spol s ro

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

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

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
MIKROCHEM spol. s r.o.Registrant: MIKROCHEM spol s ro	Za dr�hou 33, Pezinok, 902 01, Slovakia (SVK)	Active ingredient (API) manufacture	3003915723495177958

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Common questions

Is MIKROCHEM spol s ro FDA approved?: MIKROCHEM spol s ro 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 MIKROCHEM spol s ro's drugs manufactured?: The FDA register lists Pezinok. Registered operations: active ingredient (API) manufacture.

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.