01 1Olon S.p.A
01 1VALGANCICLOVIR HYDROCHLORIDE CRYSTALLINE
01 1Italy
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-09-05
Pay. Date : 2018-06-22
DMF Number : 32488
Submission : 2018-06-29
Status : Active
Type : II
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Olon Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is VALGANCICLOVIR HYDROCHLORIDE CRYSTALLINE, with a corresponding US DMF Number 32488.
Remarkably, this DMF maintains an Active status since its submission on June 29, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 05, 2018, and payment made on June 22, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
