01 1Amino Chemicals
01 1PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
01 1Malta
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-12
Pay. Date : 2019-02-19
DMF Number : 18297
Submission : 2005-04-21
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 PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE, with a corresponding US DMF Number 18297.
Remarkably, this DMF maintains an Active status since its submission on April 21, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 12, 2019, and payment made on February 19, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
