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List of Drug Master Files (DMF) for 24603 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 PANTOPRAZOLE SODIUM USP (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
24603
Active
2011-01-31
Complete
2013-08-28
2012-12-19
II
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Looking for Drug Master Files (DMF) for 24603 of Raks Pharma Pvt Ltd

Looking for Drug Master Files (DMF) for 24603 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 PANTOPRAZOLE SODIUM USP, with a corresponding US DMF Number 24603.

Remarkably, this DMF maintains an Active status since its submission on January 31, 2011, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of August 28, 2013, and payment made on December 19, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II

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