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01 1Swati Spentose

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.

GDUFA

DMF Review : Complete

Rev. Date : 2014-10-06

Pay. Date : 2013-09-23

DMF Number : 25830

Submission : 2012-02-22

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 25830 of Swati Spentose Private Ltd

Looking for Drug Master Files (DMF) for 25830 of Swati Spentose Private Ltd 1

20

Swati Spentose Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

They are recognized for SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.

One of their notable products is LIDOCAINE USP, with a corresponding US DMF Number 25830.

Remarkably, this DMF maintains an Active status since its submission on February 22, 2012, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 06, 2014, and payment made on September 23, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II