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Biocon Ltd (BION.NS)

BION.NS on National Stock Exchange of India

611.40INR
26 Mar 2019
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Latest Key Developments (Source: Significant Developments)

Biocon Says Bengaluru Facility Gets Six Form 483 Observations
Wednesday, 6 Mar 2019 

March 6 (Reuters) - Biocon Ltd ::SAYS BIOCON FACILITY COMPLETES PRE APPROVAL U.S. FDA INSPECTION.BIOCON LTD - INSPECTION AT BENGALURU FACILITY TOOK PLACE BETWEEN FEB 25 - MAR 5, RESULTING IN FORM 483 WITH SIX OBSERVATIONS.  Full Article

Biocon Says Pre-Approval Inspection Of Injectable Manufacturing Line Resulted In Form 483 With 2 Observations
Monday, 18 Feb 2019 

Feb 18 (Reuters) - Biocon Ltd ::BIOCON - PRE-APPROVAL INSPECTION OF ADDITIONAL NEW INJECTABLE MANUFACTURING LINE FOR A BIOLOGIC DRUG PRODUCT RESULTED IN FORM 483 WITH 2 OBSERVATIONS.THERE WERE NO OBSERVATIONS AND NO FORM 483 WAS ISSUED AFTER THE PRE-APPROVAL INSPECTION OF ORAL SOLID DOSAGE FACILITY .SAYS BIOCON FACILITIES COMPLETE PRE APPROVAL U.S.FDA INSPECTION.  Full Article

Biocon Says Ogivri Approved In European Union
Wednesday, 19 Dec 2018 

Dec 19 (Reuters) - Biocon Ltd ::SAYS OGIVRI, BIOSIMILAR TRASTUZUMAB JOINTLY DEVELOPED BY BIOCON AND MYLAN, HAS BEEN APPROVED IN EUROPEAN UNION.BIOCON - OGIVRI IS INDICATED FOR TREATMENT OF PATIENTS WITH HER2 POSITIVE EARLY BREAST CANCER , METASTATIC BREAST CANCER AND METASTATIC GASTRIC CANCER.  Full Article

Biocon Says Biosimilar Pegfilgrastim Co-Developed By Co Gets Approval In EU
Friday, 30 Nov 2018 

Nov 30 (Reuters) - Biocon Ltd ::BIOSIMILAR PEGFILGRASTIM CO-DEVELOPED BY BIOCON RECEIVES APPROVAL IN EU.EUROPEAN COMMISSION HAS GRANTED MARKETING AUTHORIZATION FOR FULPHILA TO CO'S PARTNER MYLAN.  Full Article

Biocon's Bengaluru Generic Formulations Facility Completes U.S. FDA Inspection With No 483 Observations
Monday, 12 Nov 2018 

Nov 12 (Reuters) - Biocon Ltd ::BIOCON'S GENERIC FORMULATIONS FACILITY IN BENGALURU COMPLETES U.S. FDA INSPECTION WITH NO 483 OBSERVATIONS.  Full Article

India's Biocon Sept-Qtr Consol Profit Surges
Thursday, 25 Oct 2018 

Oct 25 (Reuters) - Biocon Ltd ::SEPT QUARTER CONSOL PROFIT 3.55 BILLION RUPEES VERSUS PROFIT OF 688 MILLION RUPEES LAST YEAR.CONSENSUS FORECAST FOR SEPT QUARTER CONSOL PROFIT WAS 1.33 BILLION RUPEES.SEPT QUARTER CONSOL REVENUE FROM OPERATIONS 13.21 BILLION RUPEES VERSUS 9.69 BILLION RUPEES LAST YEAR.SEPT QUARTER EXCEPTIONAL ITEM OF 1.89 BILLION RUPEES.  Full Article

Biocon & Mylan Announce Positive CHMP Opinion For Ogivri
Friday, 19 Oct 2018 

Oct 19 (Reuters) - Biocon Ltd ::SAYS BIOCON AND MYLAN ANNOUNCE POSITIVE CHMP OPINION FOR OGIVRI, BIOSIMILAR TRASTUZUMAB.  Full Article

India's Biocon June Qtr Consol Profit Rises
Thursday, 26 Jul 2018 

July 26 (Reuters) - Biocon Ltd ::JUNE QUARTER CONSOL PROFIT 1.20 BILLION RUPEES VERSUS PROFIT OF 813 MILLION RUPEES LAST YEAR.JUNE QUARTER CONSOL REVENUE FROM OPERATIONS 11.24 BILLION RUPEES VERSUS 9.34 BILLION RUPEES LAST YEAR.  Full Article

India's Biocon Says Sterile Drug Product Unit In Bangalore Gets EU GMP Certification
Wednesday, 4 Jul 2018 

July 4 (Reuters) - Biocon Ltd ::STERILE DRUG PRODUCT FACILITY IN BANGALORE RECEIVES EU GMP CERTIFICATION.  Full Article

Biocon Clarifies Co Retains Economic Interest In Etanercept Collaboration With Mylan
Thursday, 28 Jun 2018 

June 28 (Reuters) - Biocon Ltd ::REFERS TO MYLAN ANNOUNCEMENT OF COMMERCIALIZATION AGREEMENT WITH LUPIN FOR BIOSIMILAR ETANERCEPT FOR CERTAIN MARKETS.CLARIFIES IT RETAINS ITS ECONOMIC INTEREST IN ARRANGEMENT IN ACCORDANCE WITH EXISTING COLLABORATION AGREEMENT WITH MYLAN.  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.

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