Register entry
GC Medical Equipment, Inc.
- Registered sites
- 3
- Drug products
- 14
- Live patents
- 0
- Countries
- 2
- Base
- United States
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingActive ingredient (API) manufactureLabellingFinished drug manufacturePackaging
Sites
Facilities
3| Site | Location | Operations | FEI |
|---|---|---|---|
| GC Biopharma Corp_Ochang Plant | Chungcheongbuk-do 28119South Korea | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3009561235 |
| GC America Inc. | Alsip, ILUnited States | Finished drug manufacture | 1410097 |
| GC Medical Equipment, Inc. | Peninsula, OHUnited States | Finished drug manufacture | 3003500482 |
Catalogue
Marketed products
14Showing 14 of 14.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| Alyglo | Human immunoglobulin G | LIQUID | BLA |
| MIPaste One | MIPaste One | PASTE, DENTIFRICE | OTC MONOGRAPH DRUG |
| MIPaste One Kids Blue Raspberry | MIPaste One Kids Blue Raspberry | PASTE, DENTIFRICE | OTC MONOGRAPH DRUG |
| MIPaste One Kids Bubble Gum | MIPaste One Kids Bubble Gum | PASTE, DENTIFRICE | OTC MONOGRAPH DRUG |
| MIPaste One Kids Cotton Candy | MIPaste One Kids Cotton Candy | PASTE, DENTIFRICE | OTC MONOGRAPH DRUG |
| MIPaste One Perio | MIPaste One Perio | PASTE, DENTIFRICE | OTC MONOGRAPH DRUG |
| MIPaste Plus Melon | MIPaste Plus Melon | PASTE, DENTIFRICE | OTC MONOGRAPH DRUG |
| MIPaste Plus Mint | MIPaste Plus Mint | PASTE, DENTIFRICE | OTC MONOGRAPH DRUG |
| MIPaste Plus Strawberry | MIPaste Plus Strawberry | PASTE, DENTIFRICE | OTC MONOGRAPH DRUG |
| MIPaste Plus Strawberry | sodium fluoride | PASTE, DENTIFRICE | OTC MONOGRAPH DRUG |
| MIPaste Plus Tutti Frutti | MIPaste Plus Tutti Frutti | PASTE, DENTIFRICE | OTC MONOGRAPH DRUG |
| MIPaste Plus Vanilla | MIPaste Plus Vanilla | PASTE, DENTIFRICE | OTC MONOGRAPH DRUG |
| MIPasteOne Kids Blue Raspberry | MI Paste One Kids Blue Raspberry | PASTE, DENTIFRICE | OTC MONOGRAPH DRUG |
| Oxygen | Oxygen | GAS | UNAPPROVED MEDICAL GAS |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.