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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>
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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.

 
Kiran Mazumdar Shaw speaks to ET NOW on extension of target action date for Trastuzumab by 3 months


 

USFDA Target Action Date for Trastuzumab reset to December 3, 2017

The US FDA has notified our partner Mylan that they will extend the target action date for their Trastuzumab 351(k) application to Dec 3, 2017 in order to review some of the clarificatory information submitted to them as a part of the application review process. This three month extension has no impact on the anticipated timetable for commercialization of this product in the U.S.


(Video Credit: CNBC TV 18)

 
Biocon: Engaged in Affordable
Innovation for Global Impact
Stock Update
 

  Company Announcements  
 

Oct. 10, 2017 
 US FDA Issues Complete  Response Letter for  Proposed Biosimilar  Pegfilgrastim

Sept. 18, 2017 
 Biocon's Facility in  Vishakhapatnam completes  US FDA  Inspection with no  observation

Sept. 07, 2017 
 Biocon´s Insulins facility in  Malaysia Receives EU GMP  Compliance Certificate

Sept. 06, 2017 
 JDRF Supports Biocon Study  of Novel, Fast-acting Oral  Insulin Tregopil for Type 1  Diabetes Treatment

Aug. 30, 2017 
 USFDA Target Action Date  for Trastuzumab Reset to  December 3, 2017

Jul. 27, 2017 
 Biocon Reports Q1FY18  Revenue at Rs 988 Crore;  EBITDA at Rs 246 Crore;  Net Profit at Rs 81 Crore

 
 
 
 


 
 
 

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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