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List of Drug Master Files (DMF) for 29066 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Raks Pharma (1)

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01 RIVAROXABAN (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
29066
Active
2015-03-18
Complete
2015-04-28
2015-02-16
II
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Looking for Drug Master Files (DMF) for 29066 of Raks Pharma Pvt Ltd

Looking for Drug Master Files (DMF) for 29066 of Raks Pharma Pvt Ltd 1

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Raks Pharma Pvt Ltd, based in India, is a pharmaceutical company that stands out with its certifications from WHO-GMP.

One of their notable products is RIVAROXABAN, with a corresponding US DMF Number 29066.

Remarkably, this DMF maintains an Active status since its submission on March 18, 2015, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of April 28, 2015, and payment made on February 16, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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