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List of Drug Master Files (DMF) for 27781 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Alembic Pharmaceuticals Limited (1)

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01 DABIGATRAN ETEXILATE MESYLATE (1)

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01 India (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
27781
Active
2013-12-31
Complete
2014-05-28
2014-03-18
II
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Looking for Drug Master Files (DMF) for 27781 of Alembic Pharmaceuticals Ltd

Looking for Drug Master Files (DMF) for 27781 of Alembic Pharmaceuticals Ltd 1

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

One of their notable products is DABIGATRAN ETEXILATE MESYLATE, with a corresponding US DMF Number 27781.

Remarkably, this DMF maintains an Active status since its submission on December 31, 2013, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 28, 2014, and payment made on March 18, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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