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List of Drug Master Files (DMF) for 22709 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Aarti Pharmalabs (1)

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01 ADAPALENE (1)

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01 India (1)

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01 Active (1)

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01 Complete (1)

22709
Active
2009-04-08
Complete
2013-05-30
2013-05-21
II
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Looking for Drug Master Files (DMF) for 22709 of Aarti Pharmalabs Ltd

Looking for Drug Master Files (DMF) for 22709 of Aarti Pharmalabs Ltd 1

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Aarti Pharmalabs Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

They are recognized for Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

One of their notable products is ADAPALENE, with a corresponding US DMF Number 22709.

Remarkably, this DMF maintains an Active status since its submission on April 08, 2009, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 30, 2013, and payment made on May 21, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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