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01 1Raks Pharma

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PharmaCompass

Looking for Drug Master Files (DMF) for 36938 of Raks Pharma Pvt Ltd

Looking for Drug Master Files (DMF) for 36938 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 CALCIUM GLUCONATE MONOHYDRATE USP, with a corresponding US DMF Number 36938.

Remarkably, this DMF maintains an Active status since its submission on April 12, 2022, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 25, 2022, and payment made on March 24, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II