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List of Drug Master Files (DMF) for 30803 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 DARUNAVIR (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
30803
Active
2016-10-05
Complete
2017-01-19
2016-09-30
II
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Looking for Drug Master Files (DMF) for 30803 of Raks Pharma Pvt Ltd

Looking for Drug Master Files (DMF) for 30803 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 DARUNAVIR, with a corresponding US DMF Number 30803.

Remarkably, this DMF maintains an Active status since its submission on October 05, 2016, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 19, 2017, and payment made on September 30, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II

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