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Looking for Drug Master Files (DMF) for 34956 of Biocon Ltd

Looking for Drug Master Files (DMF) for 34956 of Biocon Ltd 1

20

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 LENALIDOMIDE, with a corresponding US DMF Number 34956.

Remarkably, this DMF maintains an Active status since its submission on July 31, 2020, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 10, 2020, and payment made on July 17, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II