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01 1Vamsi Labs

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothVamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

GDUFA

DMF Review : Complete

Rev. Date : 2021-01-11

Pay. Date : 2020-11-04

DMF Number : 34808

Submission : 2020-04-15

Status : Active

Type : II

Vamsi Labs

Looking for Drug Master Files (DMF) for 34808 of Vamsi Labs Ltd

Looking for Drug Master Files (DMF) for 34808 of Vamsi Labs Ltd 1

20

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

They are recognized for Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.

One of their notable products is TIOTROPIUM BROMIDE MONOHYDRATE, with a corresponding US DMF Number 34808.

Remarkably, this DMF maintains an Active status since its submission on April 15, 2020, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 11, 2021, and payment made on November 04, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II