01 1Raks Pharma
01 1ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE, USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-02-27
Pay. Date : 2016-12-27
DMF Number : 31183
Submission : 2016-12-28
Status : Active
Type : II
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Raks Pharma Pvt Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.
One of their notable products is ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE, USP, with a corresponding US DMF Number 31183.
Remarkably, this DMF maintains an Active status since its submission on December 28, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 27, 2017, and payment made on December 27, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
