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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 : 2013-08-07

Pay. Date : 2013-07-29

DMF Number : 13523

Submission : 1998-09-01

Status : Active

Type : II

Centrient Pharmaceuticals

Looking for Drug Master Files (DMF) for 13523 of Centrient Pharmaceuticals Netherlands Bv

Looking for Drug Master Files (DMF) for 13523 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 NYSTATIN, with a corresponding US DMF Number 13523.

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 August 07, 2013, and payment made on July 29, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II