Register entry
Fresenius Medical Care Renal Therapies Group, LLC
- Registered sites
- 6
- Drug products
- 7
- Live patents
- 3
- Countries
- 3
- 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 testingLabellingFinished drug manufacturePackagingsterilize
Sites
Facilities
6| Site | Location | Operations | FEI |
|---|---|---|---|
| FRESENIUS MEDICAL CARE ANDINA S A S | COTAColombia | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3017307964 |
| Fresenius Medical Care de Mexico, S.A. de C.V. | ZapopanMexico | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3007102377 |
| Fresenius Medical Care North America | Knoxville, TNUnited States | Finished drug manufacture | 3017125096 |
| Fresenius USA Manufacturing, Inc | Knoxville, TNUnited States | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3013546115 |
| Fresenius Medical Care Renal Therapies Group, LLC | Lawrence, MAUnited States | Analytical testing | 3003464075 |
| Fresenius Medical Care North America | Ogden, UTUnited States | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 1713747 |
Exclusivity
Patents
3Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| PHOSLYRA | CALCIUM ACETATE | Jul 2027 |
| PHOSLYRA | CALCIUM ACETATE | Feb 2030 |
Catalogue
Marketed products
7Showing 7 of 7.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | SOLUTION | NDA |
| DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | SOLUTION | NDA |
| DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | SOLUTION | NDA |
| DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | SOLUTION | NDA |
| DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | SOLUTION | NDA |
| Sodium Chloride | Sodium Chloride | INJECTION | ANDA |
| Velphoro | sucroferric oxyhydroxide | TABLET, CHEWABLE | NDA |
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.