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Looking for Drug Master Files (DMF) for 9493 of Lusochimica Spa

Looking for Drug Master Files (DMF) for 9493 of Lusochimica Spa 1

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Lusochimica Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is NICARDIPINE HYDROCHLORIDE, with a corresponding US DMF Number 9493.

Remarkably, this DMF maintains an Active status since its submission on January 08, 1992, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 18, 2013, and payment made on December 20, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II