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PharmaCompass

Looking for Drug Master Files (DMF) for 5134 of Recordati Industria Chimica E Farmaceutica Spa

Looking for Drug Master Files (DMF) for 5134 of Recordati Industria Chimica E Farmaceutica Spa 1

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Recordati Industria Chimica E Farmaceutica Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is DOPAMINE HCl, with a corresponding US DMF Number 5134.

Remarkably, this DMF maintains an Active status since its submission on June 10, 1983, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 30, 2015, and payment made on May 30, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II