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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothFareva: One stop for innovative drug development, precision manufacturing and high-quality APIs.

GDUFA

DMF Review : Complete

Rev. Date : 2013-05-22

Pay. Date : 2013-05-01

DMF Number : 18288

Submission : 2005-04-15

Status : Active

Type : II

Company Banner

Looking for Drug Master Files (DMF) for 18288 of Excella Gmbh And Co Kg

Looking for Drug Master Files (DMF) for 18288 of Excella Gmbh And Co Kg 1

20

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

They are recognized for Fareva: One stop for innovative drug development, precision manufacturing and high-quality APIs.

One of their notable products is ROPIVACAINE HYDROCHLORIDE, with a corresponding US DMF Number 18288.

Remarkably, this DMF maintains an Active status since its submission on April 15, 2005, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 22, 2013, and payment made on May 01, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II