Shares of Gland Pharma surged as much as eight percent on Monday after the company announced that the United States Food and Drug Administration (USFDA) concluded the inspection at its Visakhapatnam facility in Andhra Pradesh with zero observation.
NSE
In a filing to the stock exchanges, Hyderabad-based Gland Pharma said that the inspection was concluded with "no action indicated" (NAI) status.
The US drug regulator conducted Good Manufacturing Practice (GMP) Inspection at the Company’s VSEZ Sterile Oncology facility at Visakhapatnam between July 20 and July 28.
"The inspection was concluded with Zero 483 observations and classification of no action indicated (NAI), " Gland Pharma said.
According to the USFDA website, Form 483 is issued to a company after the conclusion of an inspection and the NAI status indicates no objectionable conditions or practices were found during the inspection
Earlier this month, Gland Pharma announced that the USFDA completed the inspection of its Dundigal facility in Hyderabad with one observation.
In June, the pharma company stated that its Pashamylaram facility at Hyderabad had also received one observation following the pre-approval inspection for seven products by the USFDA.
Also, Gland Pharma received approval from USFDA for its new drug application for Fomepizole, which is used for the treatment of ethylene glycol and methanol poisoning.
Shares of Gland Pharma are trading 3 percent higher at Rs 1,330.50. The stock is up for the third day in a row, during which it has gained over 10 percent. The stock is up 55 percent from its 52-week low.