Is Ophtapharm AG FDA approved?

Ophtapharm AG holds 1 FDA-registered establishment in Switzerland. 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 Ophtapharm AG's drugs manufactured?

The FDA register lists Hettlingen. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

Ophtapharm AG

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: Switzerland

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Ophtapharm AG	Riethofstrasse 1, Hettlingen, 8442, Switzerland (CHE)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3005531475482198285

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Common questions

Is Ophtapharm AG FDA approved?: Ophtapharm AG holds 1 FDA-registered establishment in Switzerland. 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 Ophtapharm AG's drugs manufactured?: The FDA register lists Hettlingen. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

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.