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PharmaCompass

Looking for Drug Master Files (DMF) for 20598 of Purac Biochem Bv

Looking for Drug Master Files (DMF) for 20598 of Purac Biochem Bv 1

20

Purac Biochem Bv, based in Netherlands, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is SODIUM (S)-LACTATE SOLUTION 50%, 60% SODIUM LACTATE CONTENT, with a corresponding US DMF Number 20598.

Remarkably, this DMF maintains an Active status since its submission on June 11, 2007, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 28, 2017, and payment made on March 17, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II