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Biocon Ltd (BION.NS)

BION.NS on National Stock Exchange of India

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Latest Key Developments (Source: Significant Developments)

Biocon Says Biocon Facilities Complete Pre Approval U.S.FDA Inspection
Sunday, 17 Feb 2019 09:54pm EST 

Feb 18 (Reuters) - Biocon Ltd ::SAYS BIOCON FACILITIES COMPLETE PRE APPROVAL U.S.FDA INSPECTION.BIOCON - THERE WERE NO OBSERVATIONS OND NO FORM 48J WAS ISSUED AFTER THE PRE-APPROVAL INSPECTION OF ORAL SOLID DOSAGE FACILITY.  Full Article

India's Biocon Dec-Qtr Profit Rises
Thursday, 24 Jan 2019 07:00am EST 

Jan 24 (Reuters) - Biocon Ltd ::DEC QUARTER CONSOL PROFIT 2.17 BILLION RUPEES VERSUS PROFIT OF 919 MILLION RUPEES LAST YEAR.CONSENSUS FORECAST FOR DEC QUARTER CONSOL PROFIT WAS 1.76 BILLION RUPEES.DEC QUARTER CONSOL REVENUE FROM OPERATIONS 15.41 BILLION RUPEES VERSUS 10.58 BILLION RUPEES LAST YEAR.  Full Article

Biocon Says FDA Issues Zero 483 Observations For Bengaluru Facility
Wednesday, 14 Nov 2018 05:56am EST 

Nov 14 (Reuters) - Biocon Ltd ::BIOCON - U.S. FDA CONDUCTED PRE APPROVAL INSPECTION OF ORAL SOLID DOSAGE FORMS MANUFACTURING FACILITY AT BIOCON PARK/ BENGALURU FROM NOV 05- NOV 09.BIOCON - AUDIT CONCLUDED WITHOUT ANY OBSERVATIONS AND NO FORM 483 WAS ISSUED.  Full Article

Biocon Says European Medicines Agency's CMPH Recommends Approval Of Fulphila
Friday, 21 Sep 2018 09:33am EDT 

Sept 21 (Reuters) - Biocon Ltd ::BIOCON SAYS EUROPEAN MEDICINES AGENCY'S COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE HAS ISSUED POSITIVE OPINION RECOMMENDING APPROVAL OF FULPHILA.SAYS CHMP POSITIVE OPINION WILL NOW BE CONSIDERED BY THE EUROPEAN COMMISSION.SAYS DECISION ON APPROVAL IS EXPECTED BY NOVEMBER 2018.  Full Article

Biocon Q4 Net Profit Up 2 Percent
Thursday, 26 Apr 2018 10:55am EDT 

April 26 (Reuters) - Biocon Ltd ::Q4 NET PROFIT UP 2 PERCENT TO 1.30 BILLION RUPEES; Q4 TOTAL REVENUE 12.37 BILLION RUPEES VERSUS 9.74 BILLION RUPEES YEAR-AGO.  Full Article

Mylan, Biocon Seek To Accelerate Introduction Of Adalimumab Biosimilar In EU
Wednesday, 11 Apr 2018 07:23am EDT 

April 11 (Reuters) - Biocon Ltd ::MYLAN, BIOCON SEEK TO ACCELERATE INTRODUCTION OF ADALIMUMAB BIOSIMILAR IN EU.  Full Article

India's Biocon ‍Says U.S. FDA Completed Pre-Approval Inspection At Malaysia Unit ​
Tuesday, 20 Feb 2018 10:20pm EST 

Feb 21 (Reuters) - Biocon Ltd ::‍U.S. FDA COMPLETED PRE-APPROVAL INSPECTION AT MALAYSIA FACILITY AND ISSUED FORM 483 WITH 6 OBSERVATIONS​.  Full Article

Cytosorbents Expands Its Partnership With Biocon To Launch Cytosorb In Malaysia
Thursday, 15 Feb 2018 06:55am EST 

Feb 15 (Reuters) - Cytosorbents ::CYTOSORBENTS EXPANDS ITS PARTNERSHIP WITH BIOCON TO LAUNCH CYTOSORB® IN MALAYSIA.CYTOSORBENTS CORP - ‍BIOCON HAS EXCLUSIVE RIGHTS TO DISTRIBUTE CYTOSORB IN MALAYSIA, WHERE CYTOSORB IS ALREADY REGISTERED​.CYTOSORBENTS CORP - ‍FINANCIAL TERMS OF AGREEMENT WERE NOT DISCLOSED​.  Full Article

Mylan And Biocon Receive Positive CHMP Opinion For Semglee, Biosimilar Insulin Glargine
Monday, 29 Jan 2018 06:00am EST 

Jan 29 (Reuters) - Biocon Ltd ::MYLAN AND BIOCON RECEIVE POSITIVE CHMP OPINION FOR SEMGLEE™, BIOSIMILAR INSULIN GLARGINE.MYLAN NV - CHMP POSITIVE OPINION WILL BE CONSIDERED BY EUROPEAN COMMISSION.MYLAN NV - EUROPEAN COMMISSION DECISION ON APPROVAL IS EXPECTED IN APRIL.MYLAN NV - EUROPEAN COMMISSION DECISION ON APPROVAL IS EXPECTED IN APRIL.MYLAN - IN ADDITION TO EUROPEAN SUBMISSION, MARKETING APPLICATIONS FOR SEMGLEE BEEN SUBMITTED IN AUSTRALIA, CANADA, U.S. & PLANNED FOR KEY EMERGING MARKETS.  Full Article

Biocon And Mylan's Biosimilar Trastuzumab Gets Approval From ANVISA, Brazil
Friday, 29 Dec 2017 01:12am EST 

Dec 29 (Reuters) - Biocon Ltd ::CO AND MYLAN'S BIOSIMILAR TRASTUZUMAB RECEIVES APPROVAL FROM ANVISA, BRAZIL THROUGH THEIR PARTNER LIBBS.LIBBS FARMACEUTICA TO COMMERCIALIZE PRODUCT IN BRAZIL UNDER BRAND NAME ZEDORA.  Full Article

India's Biocon quarterly profit more than doubles, beats estimate

Jan 24 Indian biotechnology firm Biocon Ltd's quarterly profit more than doubled, handily beating analysts' estimates, largely driven by strong performance of its biologics businesses.

No consensus analysis data available.