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01 1Lupin Manufacturing Solutions

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.

GDUFA

DMF Review : Complete

Rev. Date : 2017-05-16

Pay. Date : 2017-04-12

DMF Number : 31500

Submission : 2017-04-03

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 31500 of Lupin Manufacturing Solutions Ltd

Looking for Drug Master Files (DMF) for 31500 of Lupin Manufacturing Solutions Ltd 1

20

Lupin Manufacturing Solutions Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.

They are recognized for Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.

One of their notable products is ESLICARBAZEPINE ACETATE, with a corresponding US DMF Number 31500.

Remarkably, this DMF maintains an Active status since its submission on April 03, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 16, 2017, and payment made on April 12, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II