01 1Shilpa Medicare
01 1FINGOLIMOD HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-29
Pay. Date : 2014-04-30
DMF Number : 28162
Submission : 2014-05-30
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 FINGOLIMOD HYDROCHLORIDE USP, with a corresponding US DMF Number 28162.
Remarkably, this DMF maintains an Active status since its submission on May 30, 2014, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 29, 2014, and payment made on April 30, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
