01 1Amino Chemicals
01 1ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE
01 1Malta
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-12
Pay. Date : 2013-07-08
DMF Number : 27259
Submission : 2013-07-15
Status : Active
Type : II
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Amino Chemicals Ltd, based in Malta, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE, with a corresponding US DMF Number 27259.
Remarkably, this DMF maintains an Active status since its submission on July 15, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 12, 2014, and payment made on July 08, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
