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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 : 2012-10-26

Pay. Date : 2012-12-13

DMF Number : 13250

Submission : 1998-09-29

Status : Active

Type : II

Neuland

Looking for Drug Master Files (DMF) for 13250 of Neuland Laboratories Ltd

Looking for Drug Master Files (DMF) for 13250 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 CIPROFLOXACIN HYDROCHLORIDE USP, with a corresponding US DMF Number 13250.

Remarkably, this DMF maintains an Active status since its submission on September 29, 1998, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 26, 2012, and payment made on December 13, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II