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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 : 2019-10-16

Pay. Date : 2019-09-20

DMF Number : 32435

Submission : 2018-03-30

Status : Active

Type : II

Neuland

Looking for Drug Master Files (DMF) for 32435 of Neuland Laboratories Ltd

Looking for Drug Master Files (DMF) for 32435 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 PALIPERIDONE PALMITATE STERILE, with a corresponding US DMF Number 32435.

Remarkably, this DMF maintains an Active status since its submission on March 30, 2018, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 16, 2019, and payment made on September 20, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II