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01 1Centrient Pharmaceuticals

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothCentrient 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

Centrient Pharmaceuticals

Looking for Drug Master Files (DMF) for 13749 of Centrient Pharmaceuticals Netherlands Bv

Looking for Drug Master Files (DMF) for 13749 of Centrient Pharmaceuticals Netherlands Bv 1

20

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