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List of Drug Master Files (DMF) for 30083 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 POTASSIUM DOBESILATE (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
30083
Active
2016-02-25
Complete
2016-04-01
2015-12-18
II
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Looking for Drug Master Files (DMF) for 30083 of Raks Pharma Pvt Ltd

Looking for Drug Master Files (DMF) for 30083 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 POTASSIUM DOBESILATE, with a corresponding US DMF Number 30083.

Remarkably, this DMF maintains an Active status since its submission on February 25, 2016, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of April 01, 2016, and payment made on December 18, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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