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01 1Lupin Ltd

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PharmaCompass

Looking for Drug Master Files (DMF) for 31143 of Lupin Ltd

Looking for Drug Master Files (DMF) for 31143 of Lupin Ltd 1

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Lupin 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 HYDROCORTISONE VALERATE USP, with a corresponding US DMF Number 31143.

Remarkably, this DMF maintains an Active status since its submission on December 30, 2016, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 02, 2017, and payment made on January 09, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II