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List of Drug Master Files (DMF) for 14411 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Aspen API (1)

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01 PENBUTOLOL SULFATE (1)

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01 Netherlands (1)

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01 Active (1)

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01 Complete (1)

14411
Active
1999-09-17
Complete
2014-12-02
2013-12-03
II

Looking for Drug Master Files (DMF) for 14411 of Fine Chemicals Corp Pty Ltd

Looking for Drug Master Files (DMF) for 14411 of Fine Chemicals Corp Pty Ltd 1

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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 PENBUTOLOL SULFATE, with a corresponding US DMF Number 14411.

Remarkably, this DMF maintains an Active status since its submission on September 17, 1999, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of December 02, 2014, and payment made on December 03, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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