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01 1Quimica Sintetica

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Looking for Drug Master Files (DMF) for 40075 of Quimica Sintetica Sa

Looking for Drug Master Files (DMF) for 40075 of Quimica Sintetica Sa 1

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Quimica Sintetica Sa, based in Spain, is a pharmaceutical company that stands out with its certifications from EDQM.

One of their notable products is SPINOSAD, with a corresponding US DMF Number 40075.

Remarkably, this DMF maintains an Active status since its submission on July 30, 2024, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 11, 2024, and payment made on August 15, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II