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01 1ACS DOBFAR SPA

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PharmaCompass

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BePharma
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Looking for Drug Master Files (DMF) for 21535 of Acs Dobfar Spa

Looking for Drug Master Files (DMF) for 21535 of Acs Dobfar Spa 1

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

One of their notable products is IMIPENEM (STERILE BULK), with a corresponding US DMF Number 21535.

Remarkably, this DMF maintains an Active status since its submission on April 15, 2008, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 23, 2013, and payment made on September 12, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II