Huapont Shengchem obtained Ruxolitinib Phosphate WC certificate
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- Time of issue:2022-05-27 14:07
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(Summary description)Huapont Shengchem is one of leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Ruxolitinib Phosphate (CAS Number: 1092939-17-7) API. DMF (No. 029480）has been submitted to US FDA and it is available for reference. In early time of this month, Huapont shengchem GMP management system has been inspected by Chongqing Municiple Drug Administration. Huapont Shengchem passed the inspection and obtained Ruxolitinib Phosphate WC certificate (Written confirmation for active substances exported to EU).
Label of JAKAFI® (Manufactured by Incyte Corporation) showes Ruxolitinib Phosphate tablet is a kinase inhibitor indicated for treatment of: (1) intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis in adults; (2) polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea; (3)steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older; (4) chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. A topical use drug product with new preparation (cream) was newly approved by US FDA in 2021.
Huapont Shengchem obtained Ruxolitinib Phosphate WC certificate
(Summary description)Huapont Shengchem is one of leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Ruxolitinib Phosphate (CAS Number: 1092939-17-7) API. DMF (No. 029480）has been submitted to US FDA and it is available for reference. In early time of this month, Huapont shengchem GMP management system has been inspected by Chongqing Municiple Drug Administration. Huapont Shengchem passed the inspection and obtained Ruxolitinib Phosphate WC certificate (Written confirmation for active substances exported to EU).
Label of JAKAFI® (Manufactured by Incyte Corporation) showes Ruxolitinib Phosphate tablet is a kinase inhibitor indicated for treatment of: (1) intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis in adults; (2) polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea; (3)steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older; (4) chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. A topical use drug product with new preparation (cream) was newly approved by US FDA in 2021.
- Categories:News
- Author:
- Origin:
- Time of issue:2022-05-27 14:07
- Views:0
Huapont Shengchem is one of leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Ruxolitinib Phosphate (CAS Number: 1092939-17-7) API. DMF (No. 029480）has been submitted to US FDA and it is available for reference. In early time of this month, Huapont shengchem GMP management system has been inspected by Chongqing Municiple Drug Administration. Huapont Shengchem passed the inspection and obtained Ruxolitinib Phosphate WC certificate (Written confirmation for active substances exported to EU).
Label of JAKAFI® (Manufactured by Incyte Corporation) showes Ruxolitinib Phosphate tablet is a kinase inhibitor indicated for treatment of: (1) intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis in adults; (2) polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea; (3)steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older; (4) chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. A topical use drug product with new preparation (cream) was newly approved by US FDA in 2021.
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