Ramp-up and new biosimilars should help boost profit
Biocon Ltd on Monday said the US health regulator conducted a pre-approval inspection and good manufacturing practice (GMP) examination of the API manufacturing facility and has issued a Form 483, with five observations. As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. "The US Food and Drug Administration (FDA) conducted a Pre-Approval Inspection (PAI) and GMP inspection of the Active Pharmaceutical Ingredients (API) manufacturing facility of Biocon Ltd," Biotechnology major said in a filing to BSE. At the conclusion of the inspection of the Bengaluru facility, which took place between January 20-24, 2020, the agency issued a Form 483, with five observations, the filing said. "We will respond to the FDA with a Corrective and Preventive Action Plan (CAPA) and are confident of ...
The company is uniquely positioned in the US as it is the only Indian pharmaceutical firm with two commercialised biosimilars in the market
The consolidated Ebitda margin stood at 27% in Q3FY20.
Biocon has maintained a strong base near 280 levels which is a good support level and currently has indicated a positive bullish candle pattern to imply strength
This values Biocon Biologics at Rs 21,450 crore or around $3 billion, on a pre-money equity basis
Sebi, in its October 2017 report on corporate governance, said listed firms should have a different person heading the management and another in place as chairman of the board
Even as the Street will monitor product ramp-up, commercialisation of more biosimilars will drive prospects further
Mittal takes over from Arun Chandavarkar, who retired on November 30 after 29 years at Biocon
Bengaluru-headquartered biopharmaceuticals company Biocon Ltd on Tuesday said Siddharth Mittal has taken over as its chief executive officer and joint managing director. "Siddharth Mittal has taken over as Chief Executive Officer & Joint Managing Director of the company starting December 1, 2019," the company said in a BSE filing. Mittal has been serving as Chief Financial Officer (CFO) of Biocon since August 2014, the filing said. Mittal takes over from Arun Chandavarkar who retired as chief executive and joint MD of the company on November 30. "I am very pleased to welcome Siddharth as CEO & Joint MD of Biocon," Biocon CMD Kiran Mazumdar-Shaw said.
Ogivri is used to treat breast cancer and gastric cancer and Biocon has regulatory approval to sell it in more than 80 countries worldwide.
Ogivri will be launched at a competitive discount for customers to help ensure access and increase treatment options for patients
Biswas will succeed incumbent CFO M B Chinappa, who will stay within the Biocon group of companies and join Biocon Biologics in a new role
Biocon CMD Kiran Mazumdar-Shaw opined that few pragmatic policies can help put India on the top again
The US Food and Drug Administration's (USFDA's) nod to Biocon's supplemental biologics licence application for the new unit will expand the company's capacity multifold, the company said
Accordingly, she filed a settlement application without admitting or denying the default and remitted Rs 3,01,758 in September 2019.
It continues to be the only company from Asia to feature on the prestigious US-based 'Science' magazine's annual 'Science Careers Top 20 Employers' list, since its debut in 2012
'We are trying to develop a strategy where we could make people to stop using disposable plastic devices', said Shaw
Excluding the exceptional item, the PBT grew 9 per cent on year-on-year basis
Biocon's ready-to-use pre-filled disposable pen with insulin Glargine is manufactured at its plant in Bengaluru