Is GRAXCELL PHARMACEUTICAL, LLC. FDA approved?

GRAXCELL PHARMACEUTICAL, LLC. 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 GRAXCELL PHARMACEUTICAL, LLC.'s drugs manufactured?

The FDA register lists NASH, TX. Registered operations: labelling, finished drug manufacture, packaging, relabelling, repackaging, sterilize.

What drugs does GRAXCELL PHARMACEUTICAL, LLC. make?

5 products are listed under GRAXCELL PHARMACEUTICAL, LLC. in the openFDA NDC Directory, most often as suppository; tablet; solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

GRAXCELL PHARMACEUTICAL, LLC.

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

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Registered sites: 1
Active NDC listings: 5
Labeller names: 2
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Labelling1Finished drug manufacture1Packaging1Relabelling1Repackaging1sterilize1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
GRAXCELL PHARMACEUTICAL, LLC.	401 industrial blvd, NASH, Texas (TX) 75569, United States (USA)	Labelling, Finished drug manufacture, Packaging, Relabelling, Repackaging, sterilize	3013178640056556923

Catalogue

Drug listings by form and route

5 active NDC listings: 5 human otc drug. By marketing category: OTC MONOGRAPH DRUG 5.

Dosage form	NDCs
suppository	2
tablet	2
solution	1

Route	NDCs
oral	2
rectal	2
topical	1

Labeller name on the listing	NDCs
graxcell pharmaceutical, llc	4
graxcell pharmaceutical, llc.	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
CLOTRIMAZOLE	CLOTRIMAZOLE	solution, topical	70795-8020OTC MONOGRAPH DRUG
Hemorrhoidal	COCOA BUTTER, PHENYLEPHRINE HYDROCHLORIDE	suppository, rectal	70795-1021OTC MONOGRAPH DRUG
LAXATIVE	BISACODYL	suppository, rectal	70795-1010OTC MONOGRAPH DRUG
Normal Salt	Sodium Chloride	tablet, oral	70795-1120OTC MONOGRAPH DRUG
Sodium Bicarbonate 10 gr	Sodium Bicarbonate	tablet, oral	70795-1190OTC MONOGRAPH DRUG

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Enquiry

Common questions

Is GRAXCELL PHARMACEUTICAL, LLC. FDA approved?: GRAXCELL PHARMACEUTICAL, LLC. 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 GRAXCELL PHARMACEUTICAL, LLC.'s drugs manufactured?: The FDA register lists NASH, TX. Registered operations: labelling, finished drug manufacture, packaging, relabelling, repackaging, sterilize.
What drugs does GRAXCELL PHARMACEUTICAL, LLC. make?: 5 products are listed under GRAXCELL PHARMACEUTICAL, LLC. in the openFDA NDC Directory, most often as suppository; tablet; solution. 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.