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01 1API Pharma

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Looking for Drug Master Files (DMF) for 34514 of Api Pharma Tech Llc

Looking for Drug Master Files (DMF) for 34514 of Api Pharma Tech Llc 1

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Api Pharma Tech Llc, based in Croatia, is a pharmaceutical company.

One of their notable products is PENCICLOVIR, with a corresponding US DMF Number 34514.

Remarkably, this DMF maintains an Active status since its submission on January 12, 2020, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 19, 2020, and payment made on January 13, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II