Register entry
- Registered sites
- 3
- Active NDC listings
- 17
- Labeller names
- 4
- Live patents
- 6
- Countries
- 2
- Base
- Germany
Authorisation
Registered operations
Analytical testing1Active ingredient (API) manufacture1Labelling2Finished drug manufacture2Packaging1Relabelling1Repackaging1
Sites
Registered establishments
3| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Merz Pharma GmbH & Co KGaA | Am Pharmapark, Dessau-Rosslau, D-06861, Germany (DEU) | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3006896175342543051 |
| Merz Pharma GmbH & Co. KGaA | Ludwigstrasse 22, Reinheim, D-64354, Germany (DEU) | Labelling, Finished drug manufacture, Packaging | 3006999111342543179 |
| Merz North America, Inc. | 13900 Grandview Parkway, Sturtevant, Wisconsin (WI) 53177, United States (USA) | Labelling, Relabelling, Repackaging | 3013840437028201378 |
Catalogue
Drug listings by form and route
1717 active NDC listings: 13 human prescription drug, 4 human otc drug. By marketing category: BLA 8, NDA 5, OTC MONOGRAPH DRUG 4.
| Dosage form | NDCs |
|---|---|
| injection, powder, lyophilized, for solution | 8 |
| capsule | 2 |
| cream | 2 |
| lotion | 2 |
| tablet, film coated, extended release | 2 |
| liquid | 1 |
| Route | NDCs |
|---|---|
| intramuscular | 8 |
| topical | 4 |
| oral | 3 |
| respiratory (inhalation) | 2 |
| Labeller name on the listing | NDCs |
|---|---|
| merz pharmaceuticals, llc | 10 |
| merz north america, inc. | 5 |
| merz north america | 1 |
| merz north america, inc | 1 |
Exclusivity
Patents and exclusivities
6| Patent | Product | Covers | Expiry |
|---|---|---|---|
| RE43711 | INBRIJAlevodopa | use | Feb 2029 |
| 8545878 | INBRIJAlevodopa | product | Nov 2032 |
| 8685442 | INBRIJAlevodopa | product | Nov 2032 |
| 8945612 | INBRIJAlevodopa | product | Nov 2032 |
| 9393210 | INBRIJAlevodopa | product | Nov 2032 |
| 12458615 | INBRIJAlevodopa | use | Oct 2033 |
Catalogue
Marketed products
17| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| AFTER CARE | DIMETHICONE | cream, topical | 46783-004OTC MONOGRAPH DRUG |
| AMPYRA | Dalfampridine | tablet, film coated, extended release, oral | 0259-5010NDA |
| AMPYRA | Dalfampridine | tablet, film coated, extended release, oral | 10144-427NDA |
| Cuvposa | glycopyrrolate | liquid, oral | 0259-0501NDA |
| Inbrija | levodopa | capsule, respiratory (inhalation) | 0259-6142NDA |
| Inbrija | levodopa | capsule, respiratory (inhalation) | 10144-342NDA |
| Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 | OCTINOXATE and ZINC OXIDE | lotion, topical | 46783-002OTC MONOGRAPH DRUG |
| Journee Firm Riche Broad Spectrum Sunscreen SPF 30 | TITANIUM DIOXIDE and ZINC OXIDE | cream, topical | 46783-110OTC MONOGRAPH DRUG |
| Reactive Plus Anti-Oxidant Serum plus Broad-spectrum SPF 45 | Octinoxate and Zinc Oxide | lotion, topical | 46783-222OTC MONOGRAPH DRUG |
| Xeomin | incobotulinumtoxinA | injection, powder, lyophilized, for solution, intramuscular | 0259-1605BLA |
| Xeomin | incobotulinumtoxinA | injection, powder, lyophilized, for solution, intramuscular | 0259-1610BLA |
| Xeomin | incobotulinumtoxinA | injection, powder, lyophilized, for solution, intramuscular | 0259-1620BLA |
| Xeomin | incobotulinumtoxinA | injection, powder, lyophilized, for solution, intramuscular | 0259-4110BLA |
| Xeomin | incobotulinumtoxinA | injection, powder, lyophilized, for solution, intramuscular | 0259-4150BLA |
| Xeomin | incobotulinumtoxinA | injection, powder, lyophilized, for solution, intramuscular | 46783-160BLA |
| Xeomin | incobotulinumtoxinA | injection, powder, lyophilized, for solution, intramuscular | 46783-161BLA |
| Xeomin | incobotulinumtoxinA | injection, powder, lyophilized, for solution, intramuscular | 46783-165BLA |
Neighbours
Registered in the same town
1- IDT Biologika GmbHDessau-Rosslau, DEU
Compare
Comparable companies in Germany
- Boehringer Ingelheim Biopharmaceuticals China Ltd3 sites · 127 NDC
- Beiersdorf AG3 sites · 107 NDC
- Bavarian Nordic A/S3 sites · 10 NDC
- Aesica Pharmaceuticals S.r.l.3 sites · 2 NDC
- BioNTech Manufacturing GmbH3 sites · 0 NDC
- Nuvisan France SARL3 sites · 0 NDC
- Corden Pharma International GmbH4 sites · 14 NDC
- Merck KGaA2 sites · 14 NDC
- Rentschler Biopharma SE2 sites · 8 NDC
- Symbiosis Pharmaceutical Services Limited2 sites · 3 NDC
Enquiry
Common questions
- Is Merz Pharma GmbH & Co. KGaA FDA approved?
- Merz Pharma GmbH & Co. KGaA holds 3 FDA-registered establishments across 2 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 Merz Pharma GmbH & Co. KGaA's drugs manufactured?
- At registered sites in Germany, the United States. The FDA register lists Dessau-Rosslau; Reinheim; Sturtevant, WI. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging, relabelling, repackaging.
- What drugs does Merz Pharma GmbH & Co. KGaA make?
- 17 products are listed under Merz Pharma GmbH & Co. KGaA in the openFDA NDC Directory, most often as injection, powder, lyophilized, for solution; capsule; cream. 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.