01 1Dishman Carbogen Amcis
01 1ROPIVACAINE HYDROCHLORIDE MONOHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-19
Pay. Date : 2013-02-25
DMF Number : 25506
Submission : 2011-11-14
Status : Active
Type : II
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Dishman Carbogen Amcis Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
They are recognized for Energise your science for life
One of their notable products is ROPIVACAINE HYDROCHLORIDE MONOHYDRATE, with a corresponding US DMF Number 25506.
Remarkably, this DMF maintains an Active status since its submission on November 14, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 19, 2013, and payment made on February 25, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
