Register entry
- Registered sites
- 3
- Active NDC listings
- 50
- Labeller names
- 3
- Live patents
- 0
- Countries
- 3
- Base
- Denmark
Authorisation
Registered operations
Analytical testing3Active ingredient (API) manufacture3Labelling1Finished drug manufacture1Packaging1
Sites
Registered establishments
3| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Xellia (Taizhou) Pharmaceuticals Co., Ltd.Registrant: Xellia Pharmaceuticals ApS | 108 Binhai Road, Jiaojiang District, Jiaojiang Dist., Taizhou, Zhejiang 318000, China (CHN) | Analytical testing, Active ingredient (API) manufacture | 3007422723529171201 |
| Xellia Pharmaceuticals ApS | Dalslandsgade 11, Copenhagen S, Region Hovedstaden 2300, Denmark (DNK) | Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging | 3002806860305814345 |
| Xellia Pharmaceuticals Ltd.Registrant: Xellia Pharmaceuticals ApS | Sz�ll�s utca 1-3, Budapest, Budapest H-1107, Hungary (HUN) | Analytical testing, Active ingredient (API) manufacture | 3002808179401172630 |
Catalogue
Drug listings by form and route
5050 active NDC listings: 34 human prescription drug, 16 bulk ingredient. By marketing category: ANDA 23, BULK INGREDIENT 16, NDA 11.
| Dosage form | NDCs |
|---|---|
| injection, solution | 16 |
| powder | 16 |
| injection, powder, lyophilized, for solution | 7 |
| injection | 6 |
| injection, powder, for solution | 4 |
| solution | 1 |
| Route | NDCs |
|---|---|
| intravenous | 24 |
| perineural | 8 |
| epidural | 6 |
| intracaudal | 6 |
| intramuscular | 3 |
| intrathecal | 1 |
| ophthalmic | 1 |
| subcutaneous | 1 |
| Labeller name on the listing | NDCs |
|---|---|
| xellia pharmaceuticals usa llc | 34 |
| xellia pharmaceuticals aps | 15 |
| xellia pharmaceuticals ltd | 1 |
Catalogue
Marketed products
50| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| Acetylcysteine | Acetylcysteine | injection, solution, intravenous | 70594-111ANDA |
| - | Amphotericin B | powder | 45932-0008BULK INGREDIENT |
| BUPIVACAINE HCl | Bupivacaine hydrochloride | injection, solution, epidural, intracaudal, perineural | 70594-115ANDA |
| - | Bacitracin Zinc | powder | 45932-0022BULK INGREDIENT |
| Bupivacaine HCl | Bupivacaine hydrochloride | injection, solution, epidural, intracaudal, perineural | 70594-114ANDA |
| Bupivacaine HCl | Bupivacaine Hydrochloride | injection, solution, perineural | 70594-116ANDA |
| Bupivacaine HCl | Bupivacaine hydrochloride | injection, solution, epidural, intracaudal, perineural | 70594-117ANDA |
| Bupivacaine HCl | Bupivacaine hydrochloride | injection, solution, epidural, intracaudal, perineural | 70594-118ANDA |
| Bupivacaine HCl | Bupivacaine Hydrochloride | injection, solution, perineural | 70594-119ANDA |
| Bupivacaine HCl | Bupivacaine hydrochloride | injection, solution, epidural, intracaudal, perineural | 70594-120ANDA |
| Bupivacine HCl | Bupivacaine hydrochloride | injection, solution, epidural, intracaudal, perineural | 70594-121ANDA |
| - | COLISTIMETHATE SODIUM | powder | 45932-0053BULK INGREDIENT |
| Carboprost Tromethamine | carboprost tromethamine | solution, intramuscular | 70594-112ANDA |
| Colistimethate | Colistimethate Sodium | injection, powder, for solution, intramuscular, intravenous | 70594-023ANDA |
| - | Colistimethate sodium | powder | 45932-0015BULK INGREDIENT |
| - | Colistimethate sodium | powder | 45932-0016BULK INGREDIENT |
| - | Colistin Sulfate | powder | 45932-0003BULK INGREDIENT |
| Daptomycin | Daptomycin | injection, powder, lyophilized, for solution, intravenous | 70594-034ANDA |
| Daptomycin | Daptomycin | injection, powder, lyophilized, for solution, intravenous | 70594-053NDA |
| Daptomycin | daptomycin | injection, powder, lyophilized, for solution, intravenous | 70594-060NDA |
| Daptomycin | daptomycin | injection, powder, lyophilized, for solution, intravenous | 70594-066NDA |
| - | Gramicidin | powder | 61046-0003BULK INGREDIENT |
| MEROPENEM | MEROPENEM | injection, powder, for solution, intravenous | 70594-075ANDA |
| MEROPENEM | MEROPENEM | injection, powder, for solution, intravenous | 70594-076ANDA |
| Neostigmine Methylsulfate | Neostigmine Methylsulfate | injection, intravenous | 70594-069ANDA |
| Neostigmine Methylsulfate | Neostigmine Methylsulfate | injection, intravenous | 70594-072ANDA |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | injection, intravenous | 70594-063ANDA |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | injection, intravenous | 70594-064ANDA |
| Phenylephrine Hydrochloride | PHENYLEPHRINE HYDROCHLORIDE | injection, intravenous | 70594-065ANDA |
| Polymyxin B | Polymyxin B Sulfate | injection, powder, for solution, intramuscular, intrathecal, intravenous, ophthalmic | 70594-049ANDA |
| - | Polymyxin B Sulfate | powder | 45932-0001BULK INGREDIENT |
| - | Polymyxin B Sulfate | powder | 45932-0002BULK INGREDIENT |
| - | Polymyxin B Sulfate | powder | 45932-0017BULK INGREDIENT |
| - | Polymyxin B Sulfate | powder | 45932-0018BULK INGREDIENT |
| Sumatriptan | SUMATRIPTAN SUCCINATE | injection, subcutaneous | 70594-068ANDA |
| - | Tobramycin sulfate | powder | 45932-0012BULK INGREDIENT |
| - | Tobramycin sulfate | powder | 45932-0014BULK INGREDIENT |
| - | Vancomycin | powder | 45932-0050BULK INGREDIENT |
| Vancomycin | Vancomycin | injection, solution, intravenous | 70594-041NDA |
| Vancomycin | Vancomycin | injection, solution, intravenous | 70594-042NDA |
| Vancomycin | Vancomycin | injection, solution, intravenous | 70594-043NDA |
| Vancomycin | Vancomycin | injection, solution, intravenous | 70594-044NDA |
| Vancomycin | Vancomycin | injection, solution, intravenous | 70594-056NDA |
| Vancomycin | Vancomycin | injection, solution, intravenous | 70594-057NDA |
| Vancomycin | Vancomycin | injection, solution, intravenous | 70594-058NDA |
| - | Vancomycin Hydrochloride | powder | 45932-0009BULK INGREDIENT |
| - | Vancomycin Hydrochloride | powder | 45932-0010BULK INGREDIENT |
| Vancomycin Hydrochloride | vancomycin hydrochloride | injection, powder, lyophilized, for solution, intravenous | 70594-122ANDA |
| Vancomycin Hydrochloride | vancomycin hydrochloride | injection, powder, lyophilized, for solution, intravenous | 70594-123ANDA |
| Voriconazole | Voriconazole | injection, powder, lyophilized, for solution, intravenous | 70594-067NDA |
Neighbours
Registered in the same town
12- Zhejiang Xianju Pharmaceutical Co., Ltd.Taizhou, CHN · 3 sites
- Zhejiang Yongning Pharmaceutical Co., LtdTaizhou, CHN · 2 sites
- EUROAPIBudapest, HUN
- BrightGene Bio-Medical Technology Co., Ltd.Taizhou, CHN
- Gedeon Richter Plc.Budapest, HUN
- Zhejiang Hisun Pharmaceutical Co., Ltd.Taizhou, CHN
- Zhejiang Huahai Pharmaceutical Technology Co LtdTaizhou, CHN
- Zhejiang Yongtai Pharmaceutical Co., Ltd.Taizhou, CHN
- EGIS Pharmaceuticals PLCBudapest, HUN
- Lepu Pharmaceutical Technology Co., Ltd.Taizhou, CHN
- Taizhou Juheng Biotechnology Co LtdTaizhou, CHN
- ZHEJIANG LEPU PHARMACEUTICAL CO., LTD.TAIZHOU, CHN
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Enquiry
Common questions
- Is Xellia Pharmaceuticals ApS FDA approved?
- Xellia Pharmaceuticals ApS holds 3 FDA-registered establishments across 3 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 Xellia Pharmaceuticals ApS's drugs manufactured?
- At registered sites in China, Denmark, Hungary. The FDA register lists Taizhou; Copenhagen S; Budapest. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
- What drugs does Xellia Pharmaceuticals ApS make?
- 50 products are listed under Xellia Pharmaceuticals ApS in the openFDA NDC Directory, most often as injection, solution; powder; 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.