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01 1Aurobindo Pharma Limited

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PharmaCompass

Looking for Drug Master Files (DMF) for 27021 of Apitoria Pharma Private Ltd

Looking for Drug Master Files (DMF) for 27021 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 METHENAMINE HIPPURATE USP (NON-STERILE DRUG SUBSTANCE), with a corresponding US DMF Number 27021.

Remarkably, this DMF maintains an Active status since its submission on April 09, 2013, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of July 08, 2013, and payment made on April 15, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II