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List of Drug Master Files (DMF) for 28906 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 RIFAXIMIN (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
28906
Active
2015-02-03
Complete
2015-03-27
2014-12-12
II
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Looking for Drug Master Files (DMF) for 28906 of Raks Pharma Pvt Ltd

Looking for Drug Master Files (DMF) for 28906 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 RIFAXIMIN, with a corresponding US DMF Number 28906.

Remarkably, this DMF maintains an Active status since its submission on February 03, 2015, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 27, 2015, and payment made on December 12, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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