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01 1Jubilant Generics

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PharmaCompass

Looking for Drug Master Files (DMF) for 22864 of Jubilant Biosys Ltd

Looking for Drug Master Files (DMF) for 22864 of Jubilant Biosys Ltd 1

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Jubilant Biosys 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 ESCITALOPRAM OXALATE USP (ESP PROCESS), with a corresponding US DMF Number 22864.

Remarkably, this DMF maintains an Active status since its submission on August 26, 2009, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 31, 2014, and payment made on March 20, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II