Is AENOVA ROMANIA S.R.L. FDA approved?

AENOVA ROMANIA S.R.L. 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 AENOVA ROMANIA S.R.L.'s drugs manufactured?

The FDA register lists Cornu. Registered operations: analytical testing, finished drug manufacture.

What drugs does AENOVA ROMANIA S.R.L. make?

12 products are listed under AENOVA ROMANIA S.R.L. in the openFDA NDC Directory, most often as capsule, liquid filled. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

AENOVA ROMANIA S.R.L.

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

Request a quote Claim this profile

Registered sites: 1
Active NDC listings: 12
Labeller names: 2
Live patents: 0
Countries: 1
Base: Romania

Authorisation

Registered operations

Analytical testing1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
AENOVA ROMANIA S.R.L.	#20 Carol I street, Cornu, Prahova 107180, Romania (ROU)	Analytical testing, Finished drug manufacture	2000030299565466997

Catalogue

Drug listings by form and route

12 active NDC listings: 12 drug for further processing. By marketing category: DRUG FOR FURTHER PROCESSING 12.

Dosage form	NDCs
capsule, liquid filled	12

Route	NDCs

Labeller name on the listing	NDCs
aenova romania s.r.l	9
aenova romania s.r.l.	3

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	DIPHENHYDRAMINE HYDROCHLORIDE	capsule, liquid filled	61301-8010DRUG FOR FURTHER PROCESSING
-	DIPHENHYDRAMINE HYDROCHLORIDE	capsule, liquid filled	61301-8014DRUG FOR FURTHER PROCESSING
-	Dimethicone	capsule, liquid filled	61301-8005DRUG FOR FURTHER PROCESSING
-	Dimethicone	capsule, liquid filled	61301-8009DRUG FOR FURTHER PROCESSING
-	Dimethicone	capsule, liquid filled	61301-8015DRUG FOR FURTHER PROCESSING
-	Dimethicone	capsule, liquid filled	61301-8016DRUG FOR FURTHER PROCESSING
-	Dimethicone	capsule, liquid filled	61301-8017DRUG FOR FURTHER PROCESSING
-	Dimethicone	capsule, liquid filled	61301-8018DRUG FOR FURTHER PROCESSING
-	Docusate Calcium	capsule, liquid filled	61301-8004DRUG FOR FURTHER PROCESSING
-	Docusate Sodium	capsule, liquid filled	61301-8001DRUG FOR FURTHER PROCESSING
-	Docusate Sodium	capsule, liquid filled	61301-8002DRUG FOR FURTHER PROCESSING
-	Docusate Sodium	capsule, liquid filled	61301-8003DRUG FOR FURTHER PROCESSING

Compare

Comparable companies in Romania

Antibiotice SA1 site · 2 NDC

Enquiry

Common questions

Is AENOVA ROMANIA S.R.L. FDA approved?: AENOVA ROMANIA S.R.L. 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 AENOVA ROMANIA S.R.L.'s drugs manufactured?: The FDA register lists Cornu. Registered operations: analytical testing, finished drug manufacture.
What drugs does AENOVA ROMANIA S.R.L. make?: 12 products are listed under AENOVA ROMANIA S.R.L. in the openFDA NDC Directory, most often as capsule, liquid filled. 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.