Is Digestive Care Inc. FDA approved?

Digestive Care 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 Digestive Care Inc.'s drugs manufactured?

The FDA register lists Bethlehem, PA. Registered operations: analytical testing, finished drug manufacture, packaging.

What drugs does Digestive Care Inc. make?

4 products are listed under Digestive Care Inc. in the openFDA NDC Directory, most often as capsule, delayed release. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Digestive Care Inc.

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

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

Authorisation

Registered operations

Analytical testing1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Digestive Care, Inc.Registrant: Digestive Care Inc.	1120 Win Dr., Bethlehem, Pennsylvania (PA) 18017, United States (USA)	Analytical testing, Finished drug manufacture, Packaging	1000136461831065214

Catalogue

Drug listings by form and route

4 active NDC listings: 4 human prescription drug. By marketing category: BLA 4.

Dosage form	NDCs
capsule, delayed release	4

Route	NDCs
oral	4

Labeller name on the listing	NDCs
digestive care, inc.	4

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
PERTZYE	pancrelipase	capsule, delayed release, oral	59767-004BLA
PERTZYE	pancrelipase	capsule, delayed release, oral	59767-008BLA
PERTZYE	pancrelipase	capsule, delayed release, oral	59767-016BLA
PERTZYE	pancrelipase	capsule, delayed release, oral	59767-024BLA

Neighbours

Registered in the same town

Particle Technology Group, LLCBethlehem, PA
Spray-Tek, Inc.Bethlehem, PA
Piramal Critical Care IncBethlehem, PA

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Enquiry

Common questions

Is Digestive Care Inc. FDA approved?: Digestive Care 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 Digestive Care Inc.'s drugs manufactured?: The FDA register lists Bethlehem, PA. Registered operations: analytical testing, finished drug manufacture, packaging.
What drugs does Digestive Care Inc. make?: 4 products are listed under Digestive Care Inc. in the openFDA NDC Directory, most often as capsule, delayed release. 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.