01 1Rolabo Outsourcing
01 1PALONOSETRON HYDROCHLORIDE
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-20
Pay. Date : 2014-03-10
DMF Number : 24497
Submission : 2010-12-23
Status : Active
Type : II
20
Rolabo Outsourcing Sl, based in Spain, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is PALONOSETRON HYDROCHLORIDE, with a corresponding US DMF Number 24497.
Remarkably, this DMF maintains an Active status since its submission on December 23, 2010, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of May 20, 2014, and payment made on March 10, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
