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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 : 2017-11-17

Pay. Date : 2017-05-23

DMF Number : 31410

Submission : 2017-03-28

Status : Active

Type : II

Centrient Pharmaceuticals

Looking for Drug Master Files (DMF) for 31410 of Centrient Pharmaceuticals Netherlands Bv

Looking for Drug Master Files (DMF) for 31410 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 ROSUVASTATIN CALCIUM, with a corresponding US DMF Number 31410.

Remarkably, this DMF maintains an Active status since its submission on March 28, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 17, 2017, and payment made on May 23, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II