The company has been told that the May inspection has been closed and they can carry on CAPA implementation, said Kiran Mazumdar Shaw, CMD, Biocon.
"The US Food and Drug Administration (USFDA) has issued an Establishment Inspection Report in relation to the cGMP (current good manufacturing practice) inspection of its aseptic drug product facility that was audited between May 25 -June 3, 2017," Biocon said in a BSE filing.
The company today said the expanded scope of partnership also includes addition of a new facility and ramping up the team of scientists working for it.
Axis Direct is bullish on Biocon has recommended buy rating on the stock with a target price of Rs 410 in its research report dated November 02, 2017.
In an interview to CNBC-TV18, Kiran Mazumdar Shaw, Chairperson & MD of Biocon spoke about the results and her outlook for the company.
Net Sales are expected to increase by 8.4 percent Y-o-Y (up 9.1 percent Q-o-Q) to Rs. 1018.9 crore, according to Kotak.
Sandeep Wagle of powermywealth.com suggests buying Hexaware Technologies and Biocon.
Prakash Gaba of prakashgaba.com is of the view that one can go long in Apollo Hospitals and Biocon.
This product is a part of the biosimilars portfolio being developed jointly by Biocon and Mylan. "The US Food and Drug Administration has issued a CRL for Mylan's Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar Pegfilgrastim", Biocon spokesperson said in a statement.
The company, however said it does not expect this CRL to impact the commercial launch timing of biosimilar Pegfilgrastim in the US. This product is a part of the biosimilars portfolio being developed jointly by Biocon and Mylan.
Ashwani Gujral of ashwanigujral.com recommends buying Prestige Estates, MOIL, TVS Motor, Kotak Mahindra Bank and Bata India.
In an interview to CNBC-TV18, Vishal Manchanda, Pharma Analyst at Nirmal Bang Institutional Equities shared his views and readings on the news as well as on Biocon stock.
Siyaram Silk, HEG Limited, Jindal Worldwide, Goa Carbon and VIP Industries were the stocks that hit 52-week high in the Nifty while within the BSE Index, stocks like Gillette India, Kotak Mahindra Bank, Bharat Financial, Bata India, Tata Steel, TVS Motor and TVS Electronics hit 52-week high in today's trade.
Biocon is under pressure today. The target action date for cancer drug pegfilgrastim is today.
The chairperson and managing director of Bengaluru- headquartered Biocon Ltd, with a fortune of USD 2.16 billion, was placed at the 72nd position on Forbes magazine's annual 'India Rich List 2017'.
Sudarshan Sukhani of s2analytics.com is of the view that one can buy Biocon and Bajaj Auto and can sell Indo Count Industries.
Divis Laboratories, Dr Reddy's Laboratories, Aurobindo Pharma, Biocon and Lupin will get astrological support, says Satish Gupta of astrostocktips,
VK Sharma, Head - PCG and Capital Market Strategy at HDFC Securities suggests buying Titan Company, Eicher Motors, Biocon, Dr Reddy's Labs and IDFC.
Sudarshan Sukhani of s2analytics.com is of the view that one can buy L&T, Asian Paints, Whirlpool of India, Sun TV Network and Bajaj Finance and advises selling Ajanta Pharma and Dish TV.
Mitessh Thakkar of mitesshthakkar.com is of the view that one can buy Balkrishna Industries, Exide Industries, Granules India and Just Dial and sell Repco Home Finance.
Biocon on Monday said it received zero observations for its active pharmaceutical ingredient (API) plant in Visakhapatnam, Andhra Pradesh.
Sudarshan Sukhani of s2analytics.com is of the view that one can buy Ashok Leyland, Biocon and Hindalco Industries and sell Castrol India.
The Bengaluru-based firm, which has been chasing the target since 2011, has identified these verticals as its key focus areas. Biocon had posted a revenue of Rs 4,078.7 crore in 2016-17.
The Europe GMP compliance certificate helps Biocon insulin, particularly insulin glargine to gain entry into the highly regulated Europe market.
Ashwani Gujral of ashwanigujral.com suggests buying Eicher Motors on every dip.