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01 1Lupin Ltd

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PharmaCompass

Looking for Drug Master Files (DMF) for 32623 of Lupin Ltd

Looking for Drug Master Files (DMF) for 32623 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 TOLVAPTAN, with a corresponding US DMF Number 32623.

Remarkably, this DMF maintains an Active status since its submission on May 03, 2019, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 18, 2019, and payment made on May 10, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II