Is hameln rds s.r.o. FDA approved?

hameln rds s.r.o. 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 hameln rds s.r.o.'s drugs manufactured?

The FDA register lists Modra. Registered operations: analytical testing, active ingredient (API) manufacture, labelling.

What drugs does hameln rds s.r.o. make?

2 products are listed under hameln rds s.r.o. 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.

hameln rds s.r.o.

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

Request a quote Claim this profile

Registered sites: 1
Active NDC listings: 2
Live patents: 0
Countries: 1
Base: Slovakia

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Labelling1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
hameln rds s.r.o.	Horn� 36, Modra, 90001, Slovakia (SVK)	Analytical testing, Active ingredient (API) manufacture, Labelling	3007308769644165029

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
hameln rds s.r.o.	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	epinephrine	powder	83166-0278BULK INGREDIENT
-	epinephrine bitartrate	powder	83166-0271BULK INGREDIENT

Compare

Comparable companies in Slovakia

Saneca Pharmaceuticals a.s.1 site · 6 NDC
BIOTIKA a.s.1 site · 2 NDC

Enquiry

Common questions

Is hameln rds s.r.o. FDA approved?: hameln rds s.r.o. 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 hameln rds s.r.o.'s drugs manufactured?: The FDA register lists Modra. Registered operations: analytical testing, active ingredient (API) manufacture, labelling.
What drugs does hameln rds s.r.o. make?: 2 products are listed under hameln rds s.r.o. 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.