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List of Drug Master Files (DMF) for 28945 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Royal DSM (1)

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01 COLESEVELAM HYDROCHLORIDE (1)

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01 Netherlands (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
28945
Active
2014-12-19
Complete
2015-08-04
2015-01-14
II
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Looking for Drug Master Files (DMF) for 28945 of Patheon Austria Gmbh And Co Kg

Looking for Drug Master Files (DMF) for 28945 of Patheon Austria Gmbh And Co Kg 1

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Patheon Austria Gmbh And Co Kg, based in Netherlands, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Royal DSM- Growth & Value: Purpose-led, Performance-driven.

One of their notable products is COLESEVELAM HYDROCHLORIDE, with a corresponding US DMF Number 28945.

Remarkably, this DMF maintains an Active status since its submission on December 19, 2014, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of August 04, 2015, and payment made on January 14, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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