Biocon receives EIR from USFDA for good manufacturing practice inspection

Currrent Affairs
Biocon on Friday said it has gotten the foundation review report (EIR) from US wellbeing controller for the post-endorsement and great assembling practice (GMP) investigation of its little particles fabricating office in Bengaluru.
"The EIR has been shut with a willful activity demonstrated (VAI) arrangement for the perceptions, the organization representative said in a recording to BSE.
"Biocon has gotten the EIR from the US Food and Drug Administration (FDA) for the post-endorsement and GMP assessment of its little atoms dynamic pharmaceutical fixing (API) fabricating office at twentieth KM, Biocon Campus, Bengaluru, directed between Feb 20 and Feb 26, 2020," according to the recording.
At the finish of the review a month ago, the organization had given a Form 483, with two perceptions, which were procedural in nature and are being tended to by the organization, the documenting said.
"We stay focused on worldwide guidelines of value and consistence," organization representative included.

The portions of Biocon were exchanging at Rs 257.00 each on the BSE, up 1.76 from the past close.

Biocon's Malaysia arm gets good manufacturing certificate from EU regulator

Current Affairs

Biocon Ltd's Malaysian subsidiary has received the Certificate of Good Manufacturing Practice (cGMP) compliance from the European drug regulator for its integrated insulin facility, helping it expand capacity to serve the diabetes market in the European Union.
It has received the Certificate of GMP compliance from the European Medicines Agency from the representative European inspection authority, Health Products Regulatory Authority (Ireland), said the company.
The Malaysian facility was inspected in May 2019. It is Asia's largest integrated insulin facility and manufactures drug substances and drug products in vials, cartridges, and insulin delivery devices.
The recombinant human Insulin (rh-Insulin) and insulin glargine manufactured at this facility are addressing the needs of over 350,000 diabetics in Malaysia. Biocon and Mylan's biosimilar insulin glargine, under the brand Semglee, had previously received regulatory approval from EMA in March 2018 and was launched in key European markets by its partner Mylan in November 2018.

 Over a period of 15 years, Biocon has provided over 2 billion doses of insulin, cumulatively, worldwide. Its rh-Insulin is registered in over 40 countries, while its insulin glargine has been approved in over 60. Biocon's biologics business registered a revenue growth of 96 per cent at Rs 490 crore in the first quarter of FY20. This business aims to impact 2.6 million patient lives in FY20 and aspires to position the company as a global leader, said Biocon in a statement.

Technical calls from HDFC Securities: Buy Biocon, CESC

International News

Nifty View
Nifty has taken support on its 100-DMA (day-moving average) and managed to close above 11,550. Any close below 11,500 would resume the downtrend which could push Nifty towards 200-DMA level of 11,110. However, trend would be considered bearish unless Nifty closes above 11,800.
BUY BIOCON
CMP: Rs 245
Target: Rs 260
Stop-loss: Rs 235
The stock has partially filled the gap which was formed in the range of 225-241 registered in Dec 2017. This gap could act as a bullish reversal point. Oscillators have been forming positive divergence on the daily charts, indicating stock is getting accumulated on the dips.
Considering the technical evidences discussed above, we recommend buying the stock at CMP (current market price), for the target of Rs 260, keeping a stop loss at Rs 235 on closing basis.
BUY CESC
CMP: Rs 786
Target: Rs 825
top-loss: Rs 760

 The stock has been forming higher tops and higher bottoms on the daily charts....Read More