01 1Macleods Pharmaceuticals Limited
01 1PALIPERIDONE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-10-31
Pay. Date : 2023-09-25
DMF Number : 35245
Submission : 2022-04-12
Status : Active
Type : II
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Macleods Pharmaceuticals Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is PALIPERIDONE USP, with a corresponding US DMF Number 35245.
Remarkably, this DMF maintains an Active status since its submission on April 12, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 31, 2023, and payment made on September 25, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
