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01 1Neuland Laboratories

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

GDUFA

DMF Review : Complete

Rev. Date : 2015-12-14

Pay. Date : 2015-12-07

DMF Number : 22973

Submission : 2009-07-22

Status : Active

Type : II

Neuland

Looking for Drug Master Files (DMF) for 22973 of Neuland Laboratories Ltd

Looking for Drug Master Files (DMF) for 22973 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 SALMETEROL XINAFOATE USP, with a corresponding US DMF Number 22973.

Remarkably, this DMF maintains an Active status since its submission on July 22, 2009, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of December 14, 2015, and payment made on December 07, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II