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01 1Raks Pharma

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PharmaCompass

Looking for Drug Master Files (DMF) for 36128 of Raks Pharma Pvt Ltd

Looking for Drug Master Files (DMF) for 36128 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 FDA and WHO-GMP.

One of their notable products is MONOBASIC POTASSIUM PHOSPHATE USP-NF, with a corresponding US DMF Number 36128.

Remarkably, this DMF maintains an Active status since its submission on August 26, 2021, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 07, 2021, and payment made on August 06, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II