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Results For "USFDA"

1211 News Found

Aurbindo Pharma posts Q3 FY25 profit at Rs. 846 Cr
News | February 08, 2025

Aurbindo Pharma posts Q3 FY25 profit at Rs. 846 Cr

During the quarter, US formulations revenue decreased by 2.3% YoY to Rs. 3,671 crore.


FDA approves Roche’s Susvimo as the first and only continuous delivery treatment diabetes-related blindness
Drug Approval | February 05, 2025

FDA approves Roche’s Susvimo as the first and only continuous delivery treatment diabetes-related blindness

Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME)


Gland Pharma reports Q3 FY25 revenue at Rs. 1,384 Cr
News | February 04, 2025

Gland Pharma reports Q3 FY25 revenue at Rs. 1,384 Cr

Our Q3 FY25 revenue was at Rs. 1,384.1 crore with an EBITDA of Rs. 360 crore resulting in a 26% EBITDA margin


Wockhardt’s Zaynich achieves highest-ever efficacy meeting superiority in a global, pivotal, registration- enabling Phase III study
Diagnostic Center | February 03, 2025

Wockhardt’s Zaynich achieves highest-ever efficacy meeting superiority in a global, pivotal, registration- enabling Phase III study

Such combined efficacy (achieving clinical cure and microbiologic cure) of Zaynich is highest ever among all the FDA-approved novel antibiotics developed in the last more than 10 years


Jubilant Ingrevia commissions new cGMP facility for supplying Niacinamide to global clients
News | January 31, 2025

Jubilant Ingrevia commissions new cGMP facility for supplying Niacinamide to global clients

The new facility, which has a capacity of 5,000 metric tonnes, will manufacture nutraceuticals and dietary-active ingredients for human consumption.


NATCO announces approval of its ANDA for Everolimus tablets for Oral Suspension
Drug Approval | January 31, 2025

NATCO announces approval of its ANDA for Everolimus tablets for Oral Suspension

Everolimus TFOS is a kinase inhibitor indicated in adult and paediatric patients aged one year and older with tuberous sclerosis complex for the treatment of subependymal giant cell astrocytoma


Granules strengthens ADHD portfolio with FDA approval for Lisdexamfetamine Dimesylate capsules
Drug Approval | January 31, 2025

Granules strengthens ADHD portfolio with FDA approval for Lisdexamfetamine Dimesylate capsules

Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder in adults and pediatric patients aged six years and older


Granules India Q3 FY25 PAT drops 6% to Rs 118 Cr
News | January 27, 2025

Granules India Q3 FY25 PAT drops 6% to Rs 118 Cr

The company said it voluntarily paused production at the Gagillapur plant in September 2024 for risk assessment on account of the USFDA observations


Dr Reddy’s Labs Q3 FY25 profit up 2% YoY at Rs. 1,413 Cr
News | January 23, 2025

Dr Reddy’s Labs Q3 FY25 profit up 2% YoY at Rs. 1,413 Cr

The revenue from operations in Q3 FY25 is Rs. 8,358.6 crore, up 16% YoY


Briefs: Cipla and IOL Chemicals and Pharmaceuticals
News | January 21, 2025

Briefs: Cipla and IOL Chemicals and Pharmaceuticals

Mesalazine is used to treat inflammatory bowel disease