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Results For "ANDA"

3094 News Found

Infinitus launches MCP server to bring standardized AI interoperability to healthcare
Digitisation | September 29, 2025

Infinitus launches MCP server to bring standardized AI interoperability to healthcare

New infrastructure makes it possible for healthcare organizations to integrate AI agents seamlessly into critical workflows like benefit verification and prior authorization


Caplin Steriles granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA
Drug Approval | September 04, 2025

Caplin Steriles granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA

Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure


Xspray Pharma licenses patent rights to Handa Therapeutics, secures royalty agreement
News | August 17, 2025

Xspray Pharma licenses patent rights to Handa Therapeutics, secures royalty agreement

Its lead product, Dasynoc, is awaiting FDA approval with a PDUFA date of October 7, 2025


Senores Pharmaceuticals acquires ANDAs from Teva Pharmaceuticals USA
News | August 13, 2025

Senores Pharmaceuticals acquires ANDAs from Teva Pharmaceuticals USA

The acquired ANDAs represent a market opportunity of about US$ 38 million in the USA


Revvity introduces new IVD reference standards for monitoring oncology diagnostic testing workflows
News | June 02, 2025

Revvity introduces new IVD reference standards for monitoring oncology diagnostic testing workflows

Revvity launches its first set of IVD Mimix reference standards, providing diagnostic labs with trusted quality controls for optimizing tests and monitoring workflows


Senores Pharmaceuticals acquires ANDA for Topiramate HCl 25, 50, 100 and 200 mg tablets
News | May 06, 2025

Senores Pharmaceuticals acquires ANDA for Topiramate HCl 25, 50, 100 and 200 mg tablets

Topiramate is indicated as a treatment of epilepsy and migraine


Strides acquires identified ANDAs from Nostrum Laboratories, USA
News | May 03, 2025

Strides acquires identified ANDAs from Nostrum Laboratories, USA

The portfolio consists of liquids and immediate release solid orals which are in the therapeutic segment to treat infections associated with UTIs


Aurobindo receives final ANDA approval for Rivaroxaban Tablets USP, 2.5mg
Drug Approval | April 14, 2025

Aurobindo receives final ANDA approval for Rivaroxaban Tablets USP, 2.5mg

The product will be launched in Q1FY26


Glenmark receives ANDA approval for Olopatadine Hydrochloride ophthalmic solution USP, 0.2%
Drug Approval | March 21, 2025

Glenmark receives ANDA approval for Olopatadine Hydrochloride ophthalmic solution USP, 0.2%

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC), will be distributed in the US by Glenmark Therapeutics, USA.