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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 : 2015-03-25

Pay. Date : 2014-07-07

DMF Number : 4942

Submission : 1983-04-29

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 4942 of Indena Spa

Looking for Drug Master Files (DMF) for 4942 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 RESERPINE USP, with a corresponding US DMF Number 4942.

Remarkably, this DMF maintains an Active status since its submission on April 29, 1983, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 25, 2015, and payment made on July 07, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II