Is Antibiotice SA FDA approved?

Antibiotice SA holds 1 FDA-registered establishment in Romania. 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 Antibiotice SA's drugs manufactured?

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

What drugs does Antibiotice SA make?

2 products are listed under Antibiotice SA 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.

Antibiotice SA

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: Romania

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Antibiotice SA	1 Valea Lupului Street, Iasi, Iasi 707410, Romania (ROU)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	3003489017644984809

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
antibiotice sa	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Nystatin	powder	65415-1371BULK INGREDIENT
-	Nystatin	powder	65415-1372BULK INGREDIENT

Compare

Comparable companies in Romania

AENOVA ROMANIA S.R.L.1 site · 12 NDC
Purolite S.R.L.2 sites · 4 NDC

Enquiry

Common questions

Is Antibiotice SA FDA approved?: Antibiotice SA holds 1 FDA-registered establishment in Romania. 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 Antibiotice SA's drugs manufactured?: The FDA register lists Iasi. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
What drugs does Antibiotice SA make?: 2 products are listed under Antibiotice SA 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.