FDC informed that the drug maker has received final approval from United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Cefixime 400 mg tablets.
The announcement was made at the fag end of market hours yesterday.Cefixime is used to treat bacterial infections in many different parts of the body. It belongs to the class of medicines known as cephalosporin antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.
The US drug regulator had conducted an inspection at the company's manufacturing facility located at Baddi, Himachal Pradesh, in the month of August 2024. On 13 November 2024, it had received the establishment inspection report (EIR) from USFDA with no observations (Zero 483s).
The inspection was carried out in relation to the ANDA-Cefuroxime Proxetil tablets and ANDA-Cefixime 400 mg tablets.
FDC is engaged in the manufacturing and marketing of ORS (oral rehydration salts), anti-infectives, and ophthalmics.
The companys consolidated net profit rose 3.2% to Rs 72.04 crore on 5.7% increase in net sales to Rs 513.85 crore in Q2 FY25 over Q2 FY24.
The scrip added 0.66% to currently trade at Rs 517.95 on the BSE.
Powered by Capital Market - Live News
Disclaimer: No Business Standard Journalist was involved in creation of this content
 "Stock Market, Market, Crash, Lost, decline, statistic, Crisis, Capital, BSE, NSE")
 "Starbucks")
 "Protest, Parliament Protest, Rahul Gandhi, Rahul, congress leader")
 "Carabao Cup")
 "Stock Market, Market, Crash, Funds, up, Stock, Gain, Lost, decline, statistic, Crisis, Capital, BSE, NSE")
