01 1Shilpa Medicare
01 1MELPHALAN HYDROCHLORIDE (MPH)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-04-23
Pay. Date : 2014-12-31
DMF Number : 28930
Submission : 2015-01-03
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 MELPHALAN HYDROCHLORIDE (MPH), with a corresponding US DMF Number 28930.
Remarkably, this DMF maintains an Active status since its submission on January 03, 2015, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 23, 2015, and payment made on December 31, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
