01 1Shilpa Medicare
01 1PRUCALOPRIDE SUCCINATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-10-14
Pay. Date : 2020-08-13
DMF Number : 35038
Submission : 2020-08-28
Status : Active
Type : II
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Shilpa Pharma Lifesciences 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 PRUCALOPRIDE SUCCINATE, with a corresponding US DMF Number 35038.
Remarkably, this DMF maintains an Active status since its submission on August 28, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 14, 2020, and payment made on August 13, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II
