Brexpiprazole
| Status | Pipeline |
| Development phase | |
| Therapeutic cat. | Neurology |
| Polymorphic form | anhydrous form (from I) |
| CAS No. | 913611-97-9 |
| 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
Brexpiprazole is an antipsychotic medication that is used to treat the symptoms of schizophrenia. It is also used together with other medications to treat major depressive disorder in adults. Brexpiprazole may also be used for purposes not listed in this medication guide.
Polpharma API
- Product of high chemical purity
- No N-nitrosamine impurities
- High polymorphic purity after micronization
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.
