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PharmaCompass

Looking for Drug Master Files (DMF) for 10982 of Union Quimico Farmaceutica Sa (uquifa Sa)

Looking for Drug Master Files (DMF) for 10982 of Union Quimico Farmaceutica Sa (uquifa Sa) 1

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Union Quimico Farmaceutica Sa (uquifa Sa), based in Spain, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is CIMETIDINE USP, with a corresponding US DMF Number 10982.

Remarkably, this DMF maintains an Active status since its submission on July 11, 1994, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of July 15, 2021, and payment made on July 12, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II