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Looking for Drug Master Files (DMF) for 31950 of Biocon Ltd

Looking for Drug Master Files (DMF) for 31950 of Biocon Ltd 1

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Biocon Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is EVEROLIMUS (2% BHT), with a corresponding US DMF Number 31950.

Remarkably, this DMF maintains an Active status since its submission on May 02, 2018, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 01, 2018, and payment made on February 14, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II