Register entry
Fresenius Medical Care Renal Therapies Group, LLC
Data as of · How to read this entry
- Registered sites
- 6
- Active NDC listings
- 7
- Live patents
- 3
- Countries
- 3
- Base
- United States
Authorisation
Registered operations
Analytical testing5Labelling4Finished drug manufacture5Packaging4sterilize4
Sites
Registered establishments
6| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| FRESENIUS MEDICAL CARE ANDINA S A SRegistrant: Fresenius Medical Care Renal Therapies Group, LLC | VIA FUNZA ZONA FRANCA INTEXZONA LOTE 85 KM 1, COTA, Cundinamarca 250027, Colombia (COL) | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3017307964881611969 |
| Fresenius Medical Care de Mexico, S.A. de C.V.Registrant: Fresenius Medical Care Renal Therapies Group, LLC | Paseo del Norte No. 5300, Zapopan, Jalisco 45010, Mexico (MEX) | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3007102377812652287 |
| Fresenius Medical Care North AmericaRegistrant: Fresenius Medical Care Renal Therapies Group, LLC | 5304 E Governor John Sevier HWY, Knoxville, Tennessee (TN) 37914, United States (USA) | Finished drug manufacture | 3017125096117573398 |
| Fresenius USA Manufacturing, IncRegistrant: Fresenius Medical Care Renal Therapies Group, LLC | 5105 S NATIONAL DR, Knoxville, Tennessee (TN) 37914, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3013546115033235127 |
| Fresenius Medical Care Renal Therapies Group, LLC | 350 Merrimack Street, Lawrence, Massachusetts (MA) 01843, United States (USA) | Analytical testing | 3003464075079732391 |
| Fresenius Medical Care North AmericaRegistrant: Fresenius Medical Care Renal Therapies Group, LLC | 475 West 13th Street, Ogden, Utah (UT) 84404, United States (USA) | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 1713747078401205 |
Catalogue
Drug listings by form and route
77 active NDC listings: 7 human prescription drug. By marketing category: NDA 6, ANDA 1.
| Dosage form | NDCs |
|---|---|
| solution | 5 |
| injection | 1 |
| tablet, chewable | 1 |
| Route | NDCs |
|---|---|
| intraperitoneal | 5 |
| intravenous | 1 |
| oral | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| fresenius medical care renal therapies group, llc | 7 |
Exclusivity
Patents and exclusivities
3| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 8592480 | PHOSLYRAcalcium acetate | use | Jul 2027 |
| 9089528 | PHOSLYRAcalcium acetate | use | Jul 2027 |
| 8591938 | PHOSLYRAcalcium acetate | product | Feb 2030 |
Catalogue
Marketed products
7| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | solution, intraperitoneal | 49230-188NDA |
| DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | solution, intraperitoneal | 49230-191NDA |
| DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | solution, intraperitoneal | 49230-206NDA |
| DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | solution, intraperitoneal | 49230-209NDA |
| DELFLEX | Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride | solution, intraperitoneal | 49230-212NDA |
| Sodium Chloride | Sodium Chloride | injection, intravenous | 49230-300ANDA |
| Velphoro | sucroferric oxyhydroxide | tablet, chewable, oral | 49230-645NDA |
Neighbours
Registered in the same town
11- PETNET Solutions, Inc.KNOXVILLE, TN · 2 sites
- Ionetix CorporationKnoxville, TN
- Craig SmithKnoxville, TN
- Holston Gases, Inc.Knoxville, TN
- FOCUS Scientific ServicesKnoxville, TN
- Melaleuca, Inc.Knoxville, TN
- Alcoholera de Zapopan SA de CVZapopan, MEX
- DOC BrandsKnoxville, TN
- LABORATORIOS SOPHIA, S.A. DE C.V.ZAPOPAN, MEX
- Laboratorios Zeyco SA de CVZapopan, MEX
- Tecnoglobal, PH7 S.A. DE C.V.Zapopan, MEX
Compare
Comparable companies in United States
- Fresenius Kabi USA, LLC6 sites · 561 NDC
- Spectrum Pharmaceuticals, Inc.6 sites · 240 NDC
- Ecolab Inc.6 sites · 105 NDC
- Eisai Inc.6 sites · 51 NDC
- Elanco US Inc.6 sites · 46 NDC
- Holston Gases, Inc.6 sites · 4 NDC
- General Distributing Co.6 sites · 3 NDC
- Reliant Holdings, Ltd6 sites · 1 NDC
- TransOx, Inc.6 sites · 1 NDC
- AndersonBrecon (UK) Limited6 sites · 0 NDC
Enquiry
Common questions
- Is Fresenius Medical Care Renal Therapies Group, LLC FDA approved?
- Fresenius Medical Care Renal Therapies Group, LLC holds 6 FDA-registered establishments across 3 countries. 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 Fresenius Medical Care Renal Therapies Group, LLC's drugs manufactured?
- At registered sites in Colombia, Mexico, the United States. The FDA register lists COTA; Zapopan; Knoxville, TN; Lawrence, MA; Ogden, UT. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, sterilize.
- What drugs does Fresenius Medical Care Renal Therapies Group, LLC make?
- 7 products are listed under Fresenius Medical Care Renal Therapies Group, LLC in the openFDA NDC Directory, most often as solution; injection; tablet, chewable. 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.