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01 1Aurobindo Pharma Limited

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PharmaCompass

Looking for Drug Master Files (DMF) for 39541 of Apitoria Pharma Private Ltd

Looking for Drug Master Files (DMF) for 39541 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 CEFPODOXIME PROXETIL USP (PROCESS II), with a corresponding US DMF Number 39541.

Remarkably, this DMF maintains an Active status since its submission on March 27, 2024, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 09, 2024, and payment made on March 21, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II