01 1Rolabo Outsourcing
01 1ATROPINE USP
01 1Spain
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-12-23
Pay. Date : 2015-09-22
DMF Number : 29521
Submission : 2015-09-25
Status : Active
Type : II
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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 ATROPINE USP, with a corresponding US DMF Number 29521.
Remarkably, this DMF maintains an Active status since its submission on September 25, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 23, 2015, and payment made on September 22, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
