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Results For "Shilpa"

85 News Found

Shilpa Medicare receives US approval for Varenicline Tablets, 0.5 mg and 1 mg
News | April 10, 2025

Shilpa Medicare receives US approval for Varenicline Tablets, 0.5 mg and 1 mg

Shilpa’s product has been approved as a generic version to the innovator - Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V. (PF Prism)


Shilpa’s Unit-2 passes second consecutive FDA inspection with no 483s
Drug Approval | April 09, 2025

Shilpa’s Unit-2 passes second consecutive FDA inspection with no 483s

Raichur site is the group’s largest API facility and part of a wider network of seven sites


Shilpa Biologicals partners with mAbTree Biologics AG for a novel immunooncology asset
News | March 18, 2025

Shilpa Biologicals partners with mAbTree Biologics AG for a novel immunooncology asset

This program aims to develop a fully human monoclonal antibody against a novel immune checkpoint protein that enables T cell activation


Shilpa Pharma Lifesciences received CEP from EDQM for API, Teriflunomide
Drug Approval | January 24, 2025

Shilpa Pharma Lifesciences received CEP from EDQM for API, Teriflunomide

Teriflunomide is a novel disease-modifying agent that was approved for use in the treatment of multiple sclerosis


Shilpa Medicare's Unit IV receives Eurasia GMP approval
Drug Approval | December 28, 2024

Shilpa Medicare's Unit IV receives Eurasia GMP approval

Both units of Shilpa Medicare (Unit IV and Unit VII), have now received GMP approval from Eurasia


Shilpa Medicare’s Unit VII, Nacharam, Hyderabad receives GMP certificate from EMA, Austria
News | December 22, 2024

Shilpa Medicare’s Unit VII, Nacharam, Hyderabad receives GMP certificate from EMA, Austria

The company has received the GMP Certification after successful closure of the inspection


Shilpa Medicare’s JV Oncosol gets USFDA approval for IMKELDI
News | November 28, 2024

Shilpa Medicare’s JV Oncosol gets USFDA approval for IMKELDI

IMKELDI is an advanced liquid formulation of imatinib designed to provide dosing accuracy


Shilpa Pharma Lifesciences received CEP from EDQM for API, Octreotide
Drug Approval | November 19, 2024

Shilpa Pharma Lifesciences received CEP from EDQM for API, Octreotide

Octreotide is synthetic peptide manufactured by Shilpa Pharma Lifesciences through solid phase synthesis