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Results For "ANDA"

2126 News Found

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


Senores receives ANDA approval for marketing Metoprolol Tartrate and Hydrochlorothiazide Tablet USP
Drug Approval | January 13, 2025

Senores receives ANDA approval for marketing Metoprolol Tartrate and Hydrochlorothiazide Tablet USP

Metoprolol Tartrate and Hydrochlorothiazide Tablet is the combination tablet of metoprolol tartrate, a beta adrenoceptor blocker and hydrochlorothiazide (HCTZ), a thiazide diuretic, indicated for the treatment of hypertension, to lower blood pressure


Roche’s Polivy combination therapy sets new standard of care for untreated aggressive lymphoma
Diagnostic Center | December 09, 2024

Roche’s Polivy combination therapy sets new standard of care for untreated aggressive lymphoma

Patients treated with Polivy in combination with R-CHP required fewer subsequent treatments, potentially reducing burdens on patients and healthcare systems


NABH integrates FOGSI’S maternal health standards across its certification programs
News | November 15, 2024

NABH integrates FOGSI’S maternal health standards across its certification programs

The MoU signed in 2022 has progressed and culminated in the subsumption of FOGSI-led Manyata initiative’s 20 quality standards across NABH’s Certification programs


Abbott India reports Q2 FY25 standalone PAT at Rs. 358.61 Cr
News | November 08, 2024

Abbott India reports Q2 FY25 standalone PAT at Rs. 358.61 Cr

The company has reported total income of Rs. 1,693.15 crores during the period ended September 30, 2024


Granules India receives ANDA approval for Bupropion Hydrochloride ER Tablets
Drug Approval | October 19, 2024

Granules India receives ANDA approval for Bupropion Hydrochloride ER Tablets

Granules now has a total of 67 ANDA approvals from the USFDA


CDSCO, NRAI meets WHO international standards for vaccine regulations
Policy | October 14, 2024

CDSCO, NRAI meets WHO international standards for vaccine regulations

India has been declared ‘functional’ against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI


Indoco Remedies receives final ANDA approval from the USFDA for Cetirizine Hydrochloride Tablets
Drug Approval | October 04, 2024

Indoco Remedies receives final ANDA approval from the USFDA for Cetirizine Hydrochloride Tablets

Cetirizine is used for relief of symptoms of hay fever and other allergic conditions


Alkem denies claims of Pan-D, Clavam 625 batches being substandard quality
News | September 27, 2024

Alkem denies claims of Pan-D, Clavam 625 batches being substandard quality

The samples of both products mentioned in the CDSCO list are spurious and not manufactured by Alkem


AstraZeneca advances ambition to improve standards of care in multiple cancer types
News | September 04, 2024

AstraZeneca advances ambition to improve standards of care in multiple cancer types

Presidential Symposium for NIAGARA will highlight practice-changing impact of a perioperative Imfinzi-based regimen in bladder cancer