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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 : 2013-04-23

Pay. Date : 2012-11-13

DMF Number : 26316

Submission : 2012-10-09

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 26316 of Lupin Manufacturing Solutions Ltd

Looking for Drug Master Files (DMF) for 26316 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 RUFINAMIDE USP, with a corresponding US DMF Number 26316.

Remarkably, this DMF maintains an Active status since its submission on October 09, 2012, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of April 23, 2013, and payment made on November 13, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II