USFDA inspects Gland Pharma’s Dundigal facility
The inspection was concluded with two 483 observations
The inspection was concluded with two 483 observations
The product is bioequivalent and therapeutically equivalent to the reference listed drug
The product is used to treat amyotrophic lateral sclerosis
Before joining Gland, Loomba was associated with Shalina Labs, Harman Finochem, Aurobindo Pharma, Sun Pharmaceuticals and Ranabaxy Laboratories.
The Product is expected to be the first generic approval on the market
Gland Pharma has reported total income of Rs. 1426.57 crores during the period ended September 30, 2023
The company is committed to address the observations and will submit its response to US FDA within the stipulated time
Gland Pharma has reported total income of Rs. 1246.23 crores during the period ended June 30, 2023
Gland Pharma has reported total income of Rs. 823.95 crores during the period ended March 31, 2023
Subscribe To Our Newsletter & Stay Updated