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01 1Aspen API

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PharmaCompass

01

GDUFA

DMF Review : Complete

Rev. Date : 2013-08-02

Pay. Date : 2013-01-14

DMF Number : 6026

Submission : 1985-09-03

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 6026 of Fine Chemicals Corp Pty Ltd

Looking for Drug Master Files (DMF) for 6026 of Fine Chemicals Corp Pty Ltd 1

20

Fine Chemicals Corp Pty Ltd, based in Netherlands, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Aspen API. More than just an API™

One of their notable products is FLUPHENAZINE DECANOATE, with a corresponding US DMF Number 6026.

Remarkably, this DMF maintains an Active status since its submission on September 03, 1985, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of August 02, 2013, and payment made on January 14, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II