Register entry
Merz Pharma GmbH & Co. KGaA
- Registered sites
- 3
- Drug products
- 17
- Live patents
- 6
- Countries
- 2
- Base
- Germany
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 manufacturePackagingRelabellingRepackaging
Sites
Facilities
3| Site | Location | Operations | FEI |
|---|---|---|---|
| Merz Pharma GmbH & Co KGaA | Dessau-RosslauGermany | Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture | 3006896175 |
| Merz Pharma GmbH & Co. KGaA | ReinheimGermany | Labelling, Finished drug manufacture, Packaging | 3006999111 |
| Merz North America, Inc. | Sturtevant, WIUnited States | Labelling, Relabelling, Repackaging | 3013840437 |
Exclusivity
Patents
6Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| INBRIJA | LEVODOPA | Feb 2029 |
| INBRIJA | LEVODOPA | Nov 2032 |
| INBRIJA | LEVODOPA | Oct 2033 |
Catalogue
Marketed products
17Showing 17 of 17.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| AFTER CARE | DIMETHICONE | CREAM | OTC MONOGRAPH DRUG |
| AMPYRA | Dalfampridine | TABLET, FILM COATED, EXTENDED RELEASE | NDA |
| AMPYRA | Dalfampridine | TABLET, FILM COATED, EXTENDED RELEASE | NDA |
| Cuvposa | glycopyrrolate | LIQUID | NDA |
| Inbrija | levodopa | CAPSULE | NDA |
| Inbrija | levodopa | CAPSULE | NDA |
| Journee Bio-restorative Day Balm Broad-spectrum Suncreen SPF 30 | OCTINOXATE and ZINC OXIDE | LOTION | OTC MONOGRAPH DRUG |
| Journee Firm Riche Broad Spectrum Sunscreen SPF 30 | TITANIUM DIOXIDE and ZINC OXIDE | CREAM | OTC MONOGRAPH DRUG |
| Reactive Plus Anti-Oxidant Serum plus Broad-spectrum SPF 45 | Octinoxate and Zinc Oxide | LOTION | OTC MONOGRAPH DRUG |
| Xeomin | incobotulinumtoxinA | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| Xeomin | incobotulinumtoxinA | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| Xeomin | incobotulinumtoxinA | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| Xeomin | incobotulinumtoxinA | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| Xeomin | incobotulinumtoxinA | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| Xeomin | incobotulinumtoxinA | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| Xeomin | incobotulinumtoxinA | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
| Xeomin | incobotulinumtoxinA | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | BLA |
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.