Is Synthesia, a.s. FDA approved?

Synthesia, a.s. holds 2 FDA-registered establishments in Czechia. 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 Synthesia, a.s.'s drugs manufactured?

The FDA register lists Pardubice; Rybitv�. Registered operations: analytical testing, active ingredient (API) manufacture.

What drugs does Synthesia, a.s. make?

1 product is listed under Synthesia, a.s. 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.

Synthesia, a.s.

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

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

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Synthesia, a.s.	Semtin 103, Pardubice, Czech Republic 530 02, Czech Republic (CZE)	Active ingredient (API) manufacture	3002675552644512006
V�zkumn� �stav organick�ch synt�z, a.s.Registrant: Synthesia, a.s.	296 Rybitv�, Rybitv�, Czech Republic 533 54, Czech Republic (CZE)	Analytical testing	3008581392643555535

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Ergocalciferol	powder	51364-0007BULK INGREDIENT

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Common questions

Is Synthesia, a.s. FDA approved?: Synthesia, a.s. holds 2 FDA-registered establishments in Czechia. 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 Synthesia, a.s.'s drugs manufactured?: The FDA register lists Pardubice; Rybitv�. Registered operations: analytical testing, active ingredient (API) manufacture.
What drugs does Synthesia, a.s. make?: 1 product is listed under Synthesia, a.s. 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.