Register entry
- Registered sites
- 1
- Active NDC listings
- 1
- Live patents
- 3
- Exclusivities
- 1
- Countries
- 1
- Base
- Germany
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Biofrontera Pharma GmbHRegistrant: Biofrontera Bioscience GmbH | Hemmelrather Weg 201, Leverkusen, North Rhine-Westphalia 51377, Germany (DEU) | Analytical testing | 3011764519332358501 |
Exclusivity
Patents and exclusivities
3| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 11540981 | AMELUZaminolevulinic acid hydrochloride | product | Feb 2028 |
| 11235169 | AMELUZaminolevulinic acid hydrochloride | use | Oct 2040 |
| 12280146 | AMELUZaminolevulinic acid hydrochloride | product | Dec 2043 |
| Product | Exclusivity | Until |
|---|---|---|
| AMELUZAMINOLEVULINIC ACID HYDROCHLORIDE | D-194 New dosing schedule | Oct 2027 |
Catalogue
Marketed products
1| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| AMELUZ | aminolevulinic acid hydrochloride | gel, topical | 70621-101NDA |
Neighbours
Registered in the same town
4- Bayer Healthcare Manufacturing SrlLeverkusen, DEU
- Terumo Pharmaceutical Services GmbHLeverkusen, DEU
- Currenta GmbH & Co. OHGLeverkusen, DEU
- Dynamit Nobel GmbH Explosivstoff- und SystemtechnikLeverkusen, DEU
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- Wasserburger Arzneimittelwerk GmbH1 site · 4 NDC
- Dynamit Nobel GmbH Explosivstoff- und Systemtechnik1 site · 3 NDC
Enquiry
Common questions
- Is Biofrontera Bioscience GmbH FDA approved?
- Biofrontera Bioscience 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 Biofrontera Bioscience GmbH's registered sites?
- The FDA register lists Leverkusen. Registered operations: analytical testing.
- What drugs does Biofrontera Bioscience GmbH make?
- 1 product is listed under Biofrontera Bioscience GmbH in the openFDA NDC Directory, most often as gel. 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.