USFDA

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. Alembic is one of the leaders in branded generics in India.

The Food and Drug Administration granted accelerated approval to repotrectinib (AUGTYRO, Bristol-Myers Squibb Company) for adult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and that have progressed following treatment or have no satisfactory alternative therapy.

Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as Zydus) has received final approval from the United States Food and Drug Administration (USFDA) to market Dapsone Gel, 7.5%, (USRLD : Aczone® Gel 7.5%). 

Dapsone Gel is used to treat acne and will be manufactured at the group’s topical manufacturing facility at Changodar, Ahmedabad (India). 

Dapsone Gel, 7.5% had annual sales of USD 35.8 mn in the United States (IQVIA MAT March 24).