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01 1Aragen Life Sciences

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PharmaCompass

Looking for Drug Master Files (DMF) for 34095 of Aragen Life Sciences Ltd

Looking for Drug Master Files (DMF) for 34095 of Aragen Life Sciences Ltd 1

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Aragen Life Sciences Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is PENTOSAN POLYSULFATE SODIUM, with a corresponding US DMF Number 34095.

Remarkably, this DMF maintains an Active status since its submission on September 13, 2019, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 12, 2019, and payment made on August 28, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II