01 1NerPharMa
01 1MELPHALAN HYDROCHLORIDE DRUG SUBSTANCE
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-18
Pay. Date : 2014-07-23
DMF Number : 27306
Submission : 2013-07-10
Status : Active
Type : II
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Nerpharma Srl, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA.
One of their notable products is MELPHALAN HYDROCHLORIDE DRUG SUBSTANCE, with a corresponding US DMF Number 27306.
Remarkably, this DMF maintains an Active status since its submission on July 10, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 18, 2014, and payment made on July 23, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
