Enzalutamide
| Status | Pipeline |
| Development phase | |
| Therapeutic cat. | Oncology |
| Polymorphic form | Anhydrous form R1 |
| CAS No. | 915087-33-1 |
| Reference Product | |
| Injectable Form | |
| EU DMF readiness |  |
| CEP | |
| CHINESE DMF | |
| JAPANESE DMF | |
| KOREAN DMF | |
| CANADIAN DMF | |
| CADIFA | |
| US DMF readiness | |
| OEB No. | |
| Samples |
Drug description
Enzalutamide is a prescription medicine used to treat prostate cancer in men who have received surgery or hormone therapy to lower testosterone.Enzalutamide is sometimes used when the cancer no longer responds to treatment, but has not spread to other parts of the body.Enzalutamide is also used when the cancer has responded to treatment and has spread to other parts of the body (metastatic).It is not known if enzalutamide is safe and effective in children or females.
Polpharma API
- Crystallisation and micronisation available
- PSD upon request
- European API manufacturer
Disclaimer
Products protected by patents (SPC) in Poland are developed solely for the purpose of Regulatory Submissions or R&D purposes intended to support Regulatory Submissions. These products are not offered for sale or made available in countries where such products are subject to patent (SPC) protection and where the offer for sale or any related activity constitutes patent infringement. It is within the buyer’s responsibility and liability to check the patent situation of the product in the import market(s). Based on exemption under art. 5(2) of the Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products Apixaban, Dapagliflozin (amorphous), Linagliptin, Rivaroxaban and Ticagrelor, which are protected by SPCs in Poland, can be manufactured and offered only for the purpose of export to non-EU countries, provided all requirements of the Regulationare met.
