01 1DISHMAN NETHERLANDS B.V.
01 1CALCITRIOL
01 1Netherlands
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-04-19
Pay. Date : 2018-03-26
DMF Number : 14093
Submission : 1999-04-16
Status : Active
Type : II
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Carbogen Amcis Bv, based in Netherlands, is a pharmaceutical company that stands out with its certifications from EDQM.
One of their notable products is CALCITRIOL, with a corresponding US DMF Number 14093.
Remarkably, this DMF maintains an Active status since its submission on April 16, 1999, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 19, 2018, and payment made on March 26, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
