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01 1Steroid SpA

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GDUFA

DMF Review : Complete

Rev. Date : 2025-10-14

Pay. Date : 2025-09-24

DMF Number : 39594

Submission : 2024-03-20

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 39594 of Steroid Spa

Looking for Drug Master Files (DMF) for 39594 of Steroid Spa 1

20

Steroid Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ESTRADIOL VALERATE, with a corresponding US DMF Number 39594.

Remarkably, this DMF maintains an Active status since its submission on March 20, 2024, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 14, 2025, and payment made on September 24, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II