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01 1Indena

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothIndena - Advancing botanical science with a century of innovation, quality, and trusted global expertise.

GDUFA

DMF Review : Complete

Rev. Date : 2013-03-07

Pay. Date : 2013-02-25

DMF Number : 10088

Submission : 1993-02-10

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 10088 of Indena Spa

Looking for Drug Master Files (DMF) for 10088 of Indena Spa 1

20

Indena Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

They are recognized for Indena - Advancing botanical science with a century of innovation, quality, and trusted global expertise.

One of their notable products is COLCHICINE USP, with a corresponding US DMF Number 10088.

Remarkably, this DMF maintains an Active status since its submission on February 10, 1993, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 07, 2013, and payment made on February 25, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II