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Results For "ANDA"

2089 News Found

Budget 2025: Industry expects tax incentives and thrust on affordable healthcare
Policy | January 23, 2025

Budget 2025: Industry expects tax incentives and thrust on affordable healthcare

Expand the scope of the Production-Linked Incentive (PLI) scheme and increase its allocation to cover more pharmaceutical products and raw materials


Glenmark Pharmaceuticals USA launches Phytonadione Injectable Emulsion USP
News | January 22, 2025

Glenmark Pharmaceuticals USA launches Phytonadione Injectable Emulsion USP

According to IQVIATM sales data for the 12-month period ending November 2024, the Vitamin K1 Injectable Emulsion USP, 10 mg/mL market achieved annual sales of approximately $19.7 million


Heraeus acquires Umicore’s Platinum API business outside of South America
News | January 19, 2025

Heraeus acquires Umicore’s Platinum API business outside of South America

The company ensures a reliable and strong portfolio at competitive prices without compromising on excellent quality


Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags
Drug Approval | January 18, 2025

Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags

This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles


Calquence combination approved in US for untreated mantle cell lymphoma
Drug Approval | January 18, 2025

Calquence combination approved in US for untreated mantle cell lymphoma

Based on ECHO Phase III trial results which showed more than 16 months of progression-free survival improvement vs. chemoimmunotherapy alone


AstraZeneca receives CDSCO approval to launch eculizumab in India
Drug Approval | January 17, 2025

AstraZeneca receives CDSCO approval to launch eculizumab in India

Eculizumab is indicated for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria and atypical Hemolytic Uremic Syndrome


Alembic announces USFDA final approval for Brexpiprazole Tablets
Drug Approval | January 16, 2025

Alembic announces USFDA final approval for Brexpiprazole Tablets

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets


Bayer’s pharma growth strategy progressing well as pipeline advances
News | January 15, 2025

Bayer’s pharma growth strategy progressing well as pipeline advances

Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid


Odisha to implement AB PM-JAY scheme
News | January 14, 2025

Odisha to implement AB PM-JAY scheme

The scheme is fully digitized and covers approximately 45% of India's population