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Results For "USFDA"

1355 News Found

India remains a very important part of our ecosystem: Vaios Barlas, Global Director Healthcare, Clariant and Bhushan Thekedar, Head of Global Business Development Healthcare, Clariant
interviews | February 21, 2025

India remains a very important part of our ecosystem: Vaios Barlas, Global Director Healthcare, Clariant and Bhushan Thekedar, Head of Global Business Development Healthcare, Clariant

We will continue to expand our range of purified excipients, offering pharmaceutical companies a dependable partner


Briefs: Caplin Point Laboratories, Hikal and Cipla
Drug Approval | February 10, 2025

Briefs: Caplin Point Laboratories, Hikal and Cipla

Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru


FDA approves EMBLAVEO for the treatment of adults with complicated intra-abdominal infections
News | February 08, 2025

FDA approves EMBLAVEO for the treatment of adults with complicated intra-abdominal infections

EMBLAVEOTM is the first and only monobactam/?-lactamase inhibitor combination antibiotic therapy approved by the USFDA


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
Clinical Trials | 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