Register entry
- Registered sites
- 1
- Active NDC listings
- 10
- Labeller names
- 2
- Live patents
- 29
- Countries
- 1
- Base
- Denmark
Authorisation
Registered operations
Active ingredient (API) manufacture1Finished drug manufacture1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Pharmacosmos A/S | Roervangsvej 30, Holbaek, 4300, Denmark (DNK) | Active ingredient (API) manufacture, Finished drug manufacture | 3002807874309706968 |
Catalogue
Drug listings by form and route
1010 active NDC listings: 4 human prescription drug, 3 bulk ingredient, 3 drug for further processing. By marketing category: NDA 4, BULK INGREDIENT 3, DRUG FOR FURTHER PROCESSING 3.
| Dosage form | NDCs |
|---|---|
| powder | 6 |
| injection, solution | 3 |
| injection, powder, lyophilized, for solution | 1 |
| Route | NDCs |
|---|---|
| intravenous | 4 |
| Labeller name on the listing | NDCs |
|---|---|
| pharmacosmos a/s | 6 |
| pharmacosmos therapeutics inc. | 4 |
Exclusivity
Patents and exclusivities
29| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 10414831 | MONOFERRICferric derisomaltose | substance, product | Mar 2029 |
| 11851504 | MONOFERRICferric derisomaltose | substance, product | Mar 2029 |
| 12030962 | MONOFERRICferric derisomaltose | substance, product | Mar 2029 |
| 8815301 | MONOFERRICferric derisomaltose | substance, product | Aug 2029 |
| 10189849 | COSELAtrilaciclib dihydrochloride | substance | Oct 2031 |
| 10189850 | COSELAtrilaciclib dihydrochloride | product | Oct 2031 |
| 10927120 | COSELAtrilaciclib dihydrochloride | product | Oct 2031 |
| 11040042 | COSELAtrilaciclib dihydrochloride | product | Oct 2031 |
| 8598197 | COSELAtrilaciclib dihydrochloride | substance, product | Oct 2031 |
| 9957276 | COSELAtrilaciclib dihydrochloride | substance | Oct 2031 |
| 10085992 | COSELAtrilaciclib dihydrochloride | use | Mar 2034 |
| 10966984 | COSELAtrilaciclib dihydrochloride | use | Mar 2034 |
| 11717523 | COSELAtrilaciclib dihydrochloride | use | Mar 2034 |
| 9487530 | COSELAtrilaciclib dihydrochloride | use | Mar 2034 |
| 8598186 | COSELAtrilaciclib dihydrochloride | substance, product | Dec 2034 |
| 11633489 | MONOFERRICferric derisomaltose | use | Jun 2036 |
| 12527798 | COSELAtrilaciclib dihydrochloride | use | Dec 2037 |
| 11529352 | COSELAtrilaciclib dihydrochloride | use | Jul 2039 |
| 12168666 | COSELAtrilaciclib dihydrochloride | substance, product | Nov 2040 |
Catalogue
Marketed products
10| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| COSELA | trilaciclib | injection, powder, lyophilized, for solution, intravenous | 73594-0101NDA |
| - | Dextran | powder | 49442-5040BULK INGREDIENT |
| - | Dextran | powder | 49442-5600BULK INGREDIENT |
| - | Dextran | powder | 49442-5800BULK INGREDIENT |
| - | Dextran 1 | powder | 49442-5001DRUG FOR FURTHER PROCESSING |
| - | Dextran 60 | powder | 49442-5060DRUG FOR FURTHER PROCESSING |
| - | Dextran 70 | powder | 49442-5070DRUG FOR FURTHER PROCESSING |
| Monoferric | Ferric derisomaltose | injection, solution, intravenous | 73594-9301NDA |
| Monoferric | Ferric derisomaltose | injection, solution, intravenous | 73594-9305NDA |
| Monoferric | Ferric derisomaltose | injection, solution, intravenous | 73594-9310NDA |
Compare
Comparable companies in Denmark
- Fertin Pharma A/S1 site · 25 NDC
- A/S Orthana Kemisk Fabrik1 site · 1 NDC
- Chr. Olesen Synthesis A/S1 site · 1 NDC
- Danipharm A/S1 site · 1 NDC
- Mariager Salt Specialties A/S1 site · 1 NDC
- SmartPractice Denmark ApS1 site · 1 NDC
- Syntese A/S1 site · 1 NDC
- Zealand Pharma A/S2 sites · 0 NDC
- Xellia Pharmaceuticals ApS3 sites · 50 NDC
- Lundbeck Pharmaceuticals LLC5 sites · 21 NDC
Enquiry
Common questions
- Is Pharmacosmos A/S FDA approved?
- Pharmacosmos A/S holds 1 FDA-registered establishment in Denmark. 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 Pharmacosmos A/S's drugs manufactured?
- The FDA register lists Holbaek. Registered operations: active ingredient (API) manufacture, finished drug manufacture.
- What drugs does Pharmacosmos A/S make?
- 10 products are listed under Pharmacosmos A/S in the openFDA NDC Directory, most often as powder; injection, solution; injection, powder, lyophilized, for solution. 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.