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01 1Neuland Laboratories

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PharmaCompass

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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : Complete

Rev. Date : 2016-04-15

Pay. Date : 2016-03-17

DMF Number : 25733

Submission : 2012-01-26

Status : Active

Type : II

Neuland

Looking for Drug Master Files (DMF) for 25733 of Neuland Laboratories Ltd

Looking for Drug Master Files (DMF) for 25733 of Neuland Laboratories Ltd 1

20

Neuland Laboratories Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Neuland Laboratories- A dedicated 100% API provider.

One of their notable products is DEFERASIROX, with a corresponding US DMF Number 25733.

Remarkably, this DMF maintains an Active status since its submission on January 26, 2012, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of April 15, 2016, and payment made on March 17, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II