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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 : 2021-02-08

Pay. Date : 2020-12-30

DMF Number : 35381

Submission : 2020-12-25

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 35381 of Lupin Manufacturing Solutions Ltd

Looking for Drug Master Files (DMF) for 35381 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 DEUTETRABENAZINE, with a corresponding US DMF Number 35381.

Remarkably, this DMF maintains an Active status since its submission on December 25, 2020, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 08, 2021, and payment made on December 30, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II