Is EDW PHARMA, INC. FDA approved?

EDW PHARMA, INC. holds 1 FDA-registered establishment in the United States. 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 EDW PHARMA, INC.'s registered sites?

The FDA register lists Paoli, PA. Registered operations: labelling.

What drugs does EDW PHARMA, INC. make?

4 products are listed under EDW PHARMA, INC. in the openFDA NDC Directory, most often as liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

EDW PHARMA, INC.

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

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Registered sites: 1
Active NDC listings: 4
Labeller names: 2
Live patents: 0
Countries: 1
Base: United States

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
EDW PHARMA, INCRegistrant: EDW PHARMA, INC.	3 Paoli Plaza, Suite C, Paoli, Pennsylvania (PA) 19301, United States (USA)	Labelling	3030307311080260470

Catalogue

Drug listings by form and route

4 active NDC listings: 4 human prescription drug. By marketing category: UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE 3, NDA 1.

Dosage form	NDCs
liquid	4

Route	NDCs
oral	4

Labeller name on the listing	NDCs
edw pharma	2
edw pharma, inc	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
TIGLUTIK	Riluzole	liquid, oral	70726-0303NDA
Teglutik	Riluzole	liquid, oral	70726-0304UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Teglutik	Riluzole	liquid, oral	70726-0305UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Teglutik	Riluzole	liquid, oral	70726-0306UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE

Neighbours

Registered in the same town

Edwards Pharmaceuticals, Inc.Paoli, PA
Womens Choice Pharmaceuticals, IncPaoli, PA

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Enquiry

Common questions

Is EDW PHARMA, INC. FDA approved?: EDW PHARMA, INC. holds 1 FDA-registered establishment in the United States. 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 EDW PHARMA, INC.'s registered sites?: The FDA register lists Paoli, PA. Registered operations: labelling.
What drugs does EDW PHARMA, INC. make?: 4 products are listed under EDW PHARMA, INC. in the openFDA NDC Directory, most often as liquid. 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.