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List of Drug Master Files (DMF) for 20557 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 LEVALBUTEROL HCL (1)

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01 India (1)

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01 Active (1)

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01 Complete (1)

20557
Active
2007-05-23
Complete
2013-03-07
2013-02-14
II
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Looking for Drug Master Files (DMF) for 20557 of Aarti Pharmalabs Ltd

Looking for Drug Master Files (DMF) for 20557 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 LEVALBUTEROL HCL, with a corresponding US DMF Number 20557.

Remarkably, this DMF maintains an Active status since its submission on May 23, 2007, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 07, 2013, and payment made on February 14, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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