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Annual Report 2017

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Biocon Ltd., Asia's premier biopharmaceutical company, is committed to ensure a global right to healthcare by addressing the worldwide need for safe, effective and affordable biotherapeutics.

We have harnessed the power of biotechnology through affordable innovation to enhance access to new and differentiated therapies for diseases that are chronic, where medical needs are largely unmet.

The Company is a pioneer in bringing the benefit of high quality, yet affordable, novel biologics and biosimilars to patients in India and other emerging markets. Today, we are India's largest and fully-integrated biopharmaceutical company that develops, manufactures and supplies advanced, life-saving biopharmaceuticals for diabetes, cancer and autoimmune conditions at price points that make them affordable and thus accessible.

As an innovation-led organization focused on providing affordable access, we have leveraged our inherent strengths in advanced science to develop, manufacture and deliver a rich portfolio of Small Molecules APIs & Formulations and Complex Biologics - both Novels and Biosimilars - including Monoclonal Antibodies (MAbs), rh-insulin and Insulin Analogs.

Our global scale capacities for manufacturing high quality, affordable biologics have positioned us as the world's fourth largest insulins producer, enabling us to address the growing needs of diabetes patients across the globe. As one of the leading oncology companies in India, we have brought safe, efficacious and affordable medicines for cancer to cater to the needs of patients, caregivers and medical practitioners in the country. br>


Biocon Q2FY18 Performance Highlights by Kiran Mazumdar-Shaw, CMD, Biocon

Kiran Shaw speaks to CNBC TV18 on EU GMP compliance certificate for Biocon Malaysia Facility  


Biocon´s Insulins facility in Malaysia Receives EU GMP Compliance Certificate

The EUDRA GMP certificate reflects Biocon Malaysia facility to be in compliance with the principles and guidelines of Good Manufacturing Practices for Active Substances, Sterile Drug Products and Quality Control Testing operations. The facility was inspected by EMA in April 2017.

Biocon Malaysia is one of Asia´s largest state-of-the-art integrated insulins manufacturing facilities, set up with an investment of about USD 275 million.

It is the first overseas biopharma manufacturing & research facility of Biocon, located at the BioXcell Biotech Park in Johor, Malaysia, employing over 600 professionals.

The facility is designed to manufacture rh- insulin and insulin analogs to cater to the needs of people with diabetes, in global markets.

Biocon: Engaged in Affordable
Innovation for Global Impact
Stock Update

  Company Announcements  

Dec. 13, 2017 
 Biocon´s Clarification post  media reports on “Biocon  on the FDA list for not  paying facility fee”. Biocon  has paid Facility Fee for its  API facility to USFDA in Sep  2017

Dec. 01, 2017 
 U.S. FDA Approves Mylan  and Biocon´s OgivriTM the  First Biosimilar for  Trastuzumab, for the  Treatment of HER2­Positive  Breast and Gastric Cancers

Dec. 01, 2017 
 European Medicines Agency  Accepts Marketing  Authorization Applications  for Mylan and Biocon´s  Proposed Biosimilars  Trastuzumab and  Pegfilgrastim

Nov. 23, 2017 
 Biocon Launches  KRABEVA® − Biosimilar  Bevacizumab for Treating  Several Types of Cancer in  India

Nov. 20, 2017 
 Biocon's Drug Product  Facility Receives EIR with  VAI status, Inspection  Closed

Nov. 07, 2017 
 Resubmission of Biosimilar  Trastuzumab and  Pegfilgrastim Dossiers with  EMA

Oct. 26, 2017 
 Biocon Q2FY18 Press  Release



Biocon Malaysia

  Media Coverage  

 Aug 2017:  Trastuzumab commercialisation on track, Biocon says after USFDA extends review deadline by 3 months

 July 2017:   Biocon Featured in ´Outlook Business Outperformers´ special edition.








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