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01 1Aurobindo Pharma Limited

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PharmaCompass

Looking for Drug Master Files (DMF) for 35239 of Apitoria Pharma Private Ltd

Looking for Drug Master Files (DMF) for 35239 of Apitoria Pharma Private Ltd 1

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Apitoria Pharma Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is AZILSARTAN KAMEDOXOMIL, with a corresponding US DMF Number 35239.

Remarkably, this DMF maintains an Active status since its submission on September 28, 2020, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 21, 2021, and payment made on September 28, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II