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List of Drug Master Files (DMF) for 28252 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 LURASIDONE HYDROCHLORIDE (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
28252
Active
2014-06-04
Complete
2014-08-20
2014-05-30
II
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Looking for Drug Master Files (DMF) for 28252 of Raks Pharma Pvt Ltd

Looking for Drug Master Files (DMF) for 28252 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 LURASIDONE HYDROCHLORIDE, with a corresponding US DMF Number 28252.

Remarkably, this DMF maintains an Active status since its submission on June 04, 2014, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of August 20, 2014, and payment made on May 30, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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