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Results For "ANVISA"

31 News Found

Zeon Lifesciences appoints GK Sharma as Group Technical Director
People | April 11, 2025

Zeon Lifesciences appoints GK Sharma as Group Technical Director

Sharma brings a wealth of expertise in optimizing manufacturing processes for fermentation-based APIs and sterile injectables


SMS Pharmaceuticals completes USFDA inspection at Hyderabad facility
Drug Approval | March 22, 2025

SMS Pharmaceuticals completes USFDA inspection at Hyderabad facility

The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483


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


Caplin Point receives EIR from FDA with Zero 483 observations
Drug Approval | January 07, 2025

Caplin Point receives EIR from FDA with Zero 483 observations

The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.


Briefs: Alembic Pharmaceuticals and Veerhealth Care
Drug Approval | December 12, 2024

Briefs: Alembic Pharmaceuticals and Veerhealth Care

The successful completion of RRA assessment by the USFDA, would enable company to open up its business in the USA market


Supriya Lifescience expands global footprint with Esketamine Hydrochloride approval
News | December 09, 2024

Supriya Lifescience expands global footprint with Esketamine Hydrochloride approval

Esketamine hydrochloride is a vital drug to be used for treating mental illness and is likely to significantly impact the LATAM market


Aurobindo Pharma receives USFDA approval for Estradiol Vaginal Inserts USP, 10 mcg
Drug Approval | August 06, 2024

Aurobindo Pharma receives USFDA approval for Estradiol Vaginal Inserts USP, 10 mcg

The approved product has an estimated market size of US$ 268 million for the twelve months ending June 2024, according to IQVIA


Rusan Pharma’s API plant in Ankleshwar receives USFDA GMP approval
Drug Approval | July 22, 2024

Rusan Pharma’s API plant in Ankleshwar receives USFDA GMP approval

Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well


Briefs: Eugia Pharma Specialities and IOL Chemicals and Pharmaceuticals
Drug Approval | May 06, 2024

Briefs: Eugia Pharma Specialities and IOL Chemicals and Pharmaceuticals

Eugia Pharma Specialities receives 7 observations from USFDA for Unit II


Gland Pharma appoints Satnam Singh Loomba as COO
People | April 29, 2024

Gland Pharma appoints Satnam Singh Loomba as COO

Before joining Gland, Loomba was associated with Shalina Labs, Harman Finochem, Aurobindo Pharma, Sun Pharmaceuticals and Ranabaxy Laboratories.