Register entry
- Registered sites
- 1
- Active NDC listings
- 17
- Live patents
- 0
- Countries
- 1
- Base
- Germany
Authorisation
Registered operations
Analytical testing1Labelling1Finished drug manufacture1Packaging1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Rottendorf Pharma GmbH | Ostenfelder Strasse 51-61, Ennigerloh, 59320, Germany (DEU) | Analytical testing, Labelling, Finished drug manufacture, Packaging | 3003732290315974691 |
Catalogue
Drug listings by form and route
1717 active NDC listings: 17 drug for further processing. By marketing category: DRUG FOR FURTHER PROCESSING 17.
| Dosage form | NDCs |
|---|---|
| tablet | 11 |
| tablet, film coated | 4 |
| capsule, gelatin coated | 1 |
| pellet | 1 |
| Route | NDCs |
|---|
| Labeller name on the listing | NDCs |
|---|---|
| rottendorf pharma gmbh | 17 |
Catalogue
Marketed products
17| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| - | Acoramidis hydrochloride | tablet, film coated | 49629-046DRUG FOR FURTHER PROCESSING |
| - | EMPAGLIFLOZIN | tablet | 49629-033DRUG FOR FURTHER PROCESSING |
| - | EMPAGLIFLOZIN | tablet | 49629-034DRUG FOR FURTHER PROCESSING |
| - | Lenacapavir sodium | tablet, film coated | 49629-042DRUG FOR FURTHER PROCESSING |
| - | Tacrolimus | tablet | 49629-020DRUG FOR FURTHER PROCESSING |
| - | Tacrolimus | tablet | 49629-021DRUG FOR FURTHER PROCESSING |
| - | Tacrolimus | tablet | 49629-022DRUG FOR FURTHER PROCESSING |
| - | bictegravir sodium, emtricitabine, and tenofovir alafenamide fumarate | tablet | 49629-024DRUG FOR FURTHER PROCESSING |
| - | emtricitabine and tenofovir alafenamide fumarate | tablet | 49629-026DRUG FOR FURTHER PROCESSING |
| - | emtricitabine and tenofovir disoproxil fumarate | tablet, film coated | 49629-010DRUG FOR FURTHER PROCESSING |
| - | emtricitabine, rilpivirine hydrochloride and tenofovir disoproxil fumarate | tablet, film coated | 49629-014DRUG FOR FURTHER PROCESSING |
| - | emtricitabine, rilpivirine hydrochloride, and tenofovir alafenamide fumarate | tablet | 49629-017DRUG FOR FURTHER PROCESSING |
| - | sodium phenylbutyrate | pellet | 49629-043DRUG FOR FURTHER PROCESSING |
| - | tamsulosin hydrochloride | capsule, gelatin coated | 49629-011DRUG FOR FURTHER PROCESSING |
| - | telmisartan and hydrochlorothiazide | tablet | 49629-030DRUG FOR FURTHER PROCESSING |
| - | telmisartan and hydrochlorothiazide | tablet | 49629-031DRUG FOR FURTHER PROCESSING |
| - | telmisartan and hydrochlorothiazide | tablet | 49629-032DRUG FOR FURTHER PROCESSING |
Compare
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- Solupharm Pharmazeutische Erzeugnisse GmbH1 site · 10 NDC
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- Thomas Brunner Hygiene GmbH1 site · 8 NDC
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- Fidelio Healthcare Limburg GmbH1 site · 6 NDC
Enquiry
Common questions
- Is Rottendorf Pharma GmbH FDA approved?
- Rottendorf Pharma GmbH holds 1 FDA-registered establishment in Germany. 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 Rottendorf Pharma GmbH's drugs manufactured?
- The FDA register lists Ennigerloh. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
- What drugs does Rottendorf Pharma GmbH make?
- 17 products are listed under Rottendorf Pharma GmbH in the openFDA NDC Directory, most often as tablet; tablet, film coated; capsule, gelatin coated. 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.