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List of Drug Master Files (DMF) for 31667 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 ELTROMBOPAG OLAMINE (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
31667
Active
2017-04-29
Complete
2017-06-01
2017-04-21
II
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Looking for Drug Master Files (DMF) for 31667 of Raks Pharma Pvt Ltd

Looking for Drug Master Files (DMF) for 31667 of Raks Pharma Pvt Ltd 1

20

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 ELTROMBOPAG OLAMINE, with a corresponding US DMF Number 31667.

Remarkably, this DMF maintains an Active status since its submission on April 29, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 01, 2017, and payment made on April 21, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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