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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 : 2013-01-08

Pay. Date : 2012-12-13

DMF Number : 18892

Submission : 2005-10-21

Status : Active

Type : II

Neuland

Looking for Drug Master Files (DMF) for 18892 of Neuland Laboratories Ltd

Looking for Drug Master Files (DMF) for 18892 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 LEVOFLOXACIN USP (HEMIHYDRATE), with a corresponding US DMF Number 18892.

Remarkably, this DMF maintains an Active status since its submission on October 21, 2005, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 08, 2013, and payment made on December 13, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II