Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
KEY PRODUCTS
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01 1Centrient Pharmaceuticals
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01 1CEFADROXIL MONOHYDRATE USP (PURIDROX ®)
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01 1Netherlands
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01 1Active
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01 1Complete
Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-22
Pay. Date : 2013-01-11
DMF Number : 13749
Submission : 1998-09-01
Status : Active
Type : II
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Centrient Pharmaceuticals Netherlands Bv, based in Netherlands, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
They are recognized for Centrient is a leading manufacturer of Beta-Lactam Antibiotics and a provider of next-generation Statins and Antifungals.
One of their notable products is CEFADROXIL MONOHYDRATE USP (PURIDROX ®), with a corresponding US DMF Number 13749.
Remarkably, this DMF maintains an Active status since its submission on September 01, 1998, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 22, 2014, and payment made on January 11, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II