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01 1Emnar Pharma

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GDUFA

DMF Review : Complete

Rev. Date : 2026-01-28

Pay. Date : 2025-12-01

DMF Number : 35441

Submission : 2020-12-25

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 35441 of Emnar Pharma Private Ltd

Looking for Drug Master Files (DMF) for 35441 of Emnar Pharma Private Ltd 1

20

Emnar Pharma Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is LEVETIRACETAM USP, with a corresponding US DMF Number 35441.

Remarkably, this DMF maintains an Active status since its submission on December 25, 2020, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 28, 2026, and payment made on December 01, 2025, indicating their dedication to facilitating drug approvals, Categorized as Type II