Biocon India Limited

To be an integrated biotechnology enterprise of global distinction.


Essential to this Mission is Excellence in:

• Intellectual asset creation through discovery, research and development.

• State-of-the-art manufacturing capabilities.

• Internationally benchmarked quality and regulatory systems.

• New medical insight through disease specific clinical research.

• Customer relationship through outstanding products and services.

• Human resource development through training, mentoring and empowering.

• Management of research and business partnerships.

• Mr. Peter Bains.

• Prof. Catherine Rosenberg.

• Prof. Ravi Mazumdar.

• Mr. John Shaw.

• Ms. Kiran Mazumdar-Shaw.

• Mr. Suresh Talwar.

• Dr. Bala S. Manian.

• Prof. Charles L. Cooney.

• Dr. Neville Bain.

Biocon follows good manufacturing, laboratory and documentation practices that ensure consistent high quality results. Our state-of-the-art analytical facilities monitor and maintain strict quality of our products, processes and services, consistently meeting Ph.Eur, USP and other national and international quality standards.


Biocons quality chain covers three key functional areas:

• Quality Control

• Quality Assurance

• Regulatory Affairs

Quality Control :

Quality Control (QC) is responsible for all analyses undertaken at Biocon. From analytical support during product development and validations to training Biocon customers, QC is supported by a highly qualified team of professionals.


Quality Assurance (QA)

• Is responsible for implementation of quality systems and release of all manufactured products.

• Develops and ensures harmonisation of all systems throughout the organisation. It is also responsible for all audits including regulatory (national and international), customer, GMP, GLP and GCP.

Regulatory Affairs :

Regulatory Affairs ensures compliance with national and international regulatory requirements.

• To maintain the highest quality standards for all Biocon products.

• To develop novel analytical methods for new products.

• To maintain and monitor quality systems within Biocon according to national and international quality standards.

• To register Biocon's drug products in many more regulated markets.

• To file regulatory dossiers for new products.

• To ensure personnel validation through training and evaluation.

• To support customers with their technical and regulatory queries.

• An Impressive track record in filing regulatory documents in CTD (common Technical documents) format, worldwide.

• Filing of IMPD and approval of Clinical trial application to conduct clinical study in EU.

• Filing of Dossiers for Human Insulin formulations with product registered in 22 countries.

• Drug Master files for small molecules and registration of the same in EU through Mutual recognition procedure (MRP) and Decentralised procedures (DCP).

• Dossiers for Oral formulations and parenterals.

• Approval for our products and testing facilities by the Indian state and central Drug Control Authorities.

• For the period between April 2008 and May 2009, Biocon has undergone 48 successful compliance audits by various national and international customers and regulatory authorities.

November 29, 1978

Biocons Founding Day the start of a biorevolution in India. Over the years, Biocon has evolved from an enzyme manufacturing company into a fully integrated biopharmaceutical enterprise. Today, we leverage a formidable combination of proprietary fermentation technologies and research skills to develop affordable therapy for unmet medical needs Biocon India is incorporated as a joint venture between Biocon Biochemicals Ltd. of Ireland and an Indian entrepreneur, Kiran Mazumdar-Shaw


1979

Biocon is the first Indian company to manufacture and export enzymes to USA and Europe.


1989

Unilever plc. acquires Biocon Biochemicals Ltd. in Ireland and merges it with its subsidiary, Quest International. Biocon is the first Indian biotech company to receive US funding for proprietary technologies


1990

Biocon scales up its in-house research programme, based on a proprietary solid substrate fermentation technology, from pilot to plant level.


1993

Biocons R&D and manufacturing facilities receive ISO 9001 certification from RWTUV, Germany.


1994

Biocon establishes Syngene International Pvt. Ltd. as a Custom research Company (CRC) to address the growing need for outsourced R&D in the pharmaceutical sector


1996

The commercial success of Biocon's proprietary fermentation plant leads to a 3-fold expansion. Biocon leverages its technology platform to enter bio pharmaceuticals and statins.


1997

Biocon spearheads initiatives in human healthcare through a dedicated manufacturing facility.


1998

Unilever inks a deal with ICI to sell its specialty chemicals division of which Quest International is a part. Unilever agrees to sell its shareholding in Biocon to the Indian promoters. Biocon becomes an independent entity


2000

Biocon commissions its first fully automated submerged fermentation plant to produce specialty pharmaceuticals. Biocon establishes Clinigene, India's first Clinical Research Organisation (CRO) to pursue clinical research and development.


2001

Biocon becomes the first Indian company to be approved by US FDA for the manufacture of lovastatin, a cholesterol-lowering molecule. Biocons proprietary bioreactor, PlaFractor is granted a US 2001 and world-wide patent


2002

Clinigenes clinical laboratory is the first in India to receive CAP accreditation.


2003

Biocon is the first company worldwide to develop human insulin on a Pichia expression system.


2004

Biocon creates a buzz in the stock market in March 2004 with its hugely successful IPO. Day 1 on the bourses closes with a market value of $1.11 billion, making Biocon only the second Indian company to cross the $1 billion mark on the first day of listing.


2005

Biocon signs a commercial agreement for supply of insulin API to Asia, Africa and the Middle East.


2006

Biocon inaugurates Biocon Biopharmaceuticals, Indias largest multi-product Biologics facility at Biocon Park. Biocon inaugurates Biocon Park, India's largest integrated biotechnology hub, comprising an integrated cluster of research laboratories and manufacturing facilities spread across 90 acres in KIADB (Karnataka Industrial Areas Development Board) industrial estate.

Kiran Mazumdar-Shaw has received several awards on behalf of Biocon and in her personal capacity as one of India's leading business entrepreneurs.


2010

• Biocon wins Bio-Excellence Award for Outstanding Achievement in the Healthcare Sector at Bangalore Bio

2009

• Biocon among Top 20 Indian companies in Forbes ‘Best Under A Billion’ list.

• Biocon wins Bio-Excellence Award for Outstanding Achievement in the Healthcare Sector at Bangalore Bio.

• Syngene wins Bio-Excellence Award for outstanding achievement in the Biotech Service Sector at Bangalore Bio.

• Biocon bags IDMA Best Patent of the year award.

• BIOMAb EGFR was voted ‘Bio-Spectrum Asia-Pacific Product of the year 2008.

• Biocon wins prestigious BioSingapore Asia Pacific Biotechnology Award for Best Listed Company

2008

• Biocon is ranked among the top 20 global biotechnology companies (Source: Med Ad News, June 2008)

• Biocon is the 7th largest biotech employer in the world (Source: Med Ad News, June 2008)

2007

• Syngene receives "BioServices Company of the Year", BioSpectrum Awards

• Biocon's BIOMAb EGFR wins "Product of the Year.

• BioSpectrum Awards.

2006

• Best IT User Award in the Pharmaceutical Sector, NASSCOM.

2004

• India's first and No. 1 biotech company with a global ranking of 16* (Source: Biospectrum July 2004)

• Biocon in India's top 5 Life Sciences companies (at close of trade as on July 30, 2004).

• Best Reinvention of HR Function Award, Indira Group, Mumbai.

• Best Employer Of India Award, Hewitt

2003

• Bio-Business Award for bio-entrepreneurship, Rabo India.

• Express Pharma Pulse Award for excellence in the pharmaceutical industry.

2001

• Biotech Product, Process Development and Commercialisation Award, Department of Biotechnology, Ministry of Science and Technology, Government of India

2000

• Technology Pioneer Recognition, World Economic Forum

1985

• Export Performance Award, Karnataka State Financial Corporation (KSFC).
  

• National Award for Best Small Industry, Government of India.

2010

• Featured on the Forbes list of ‘The World’s 100 Most Powerful Women.

• Featured on the Financial Times ‘Top 50 Women in Business list.

• Named among TIME magazine’s 100 most influential people in the world.

2009

• Honoured with Nikkei Asia Prize for Regional Growth.

• Honoured with 'Express Pharmaceutical Leadership Summit Award for Dynamic Entrepreneur.

2008

• Honorary Degree of Doctor of Science from the Heriot-Watt University, Edinburgh.

• Honorary Degree of Doctor of Science from the University of Glasgow.

2007

• Honoured with the, 'Veuve Clicquot Initiative For Economic Development For Asia' award.

• Honorary Doctor of Technology, University of Abertay, Dundee ( UK )

2005

• Padmabhushan Award , one of India's highest civilian honours, from the President of India, Dr. APJ Abdul Kalam.

• Honorary Degree of Doctor of Science (Honoris Causa) from Indian Institute of Technology, Roorkee.

• The Indian Chamber of Commerce Lifetime Achievement Award.

Biocons discovery-led R&D focuses on the entire drug development pathway - from process development, to non-clinical and clinical research. The depth and breadth of our technological and scientific expertise enables us to develop new and affordable therapeutics for the worlds most debilitating diseases. R&D’s ability to leverage frontier science, from cloning right through to identifying novel clinical biomarkers, continues to advance Biocons reputation as a leading innovator company.

We have on our R&D team, outstanding scientists from the best institutes around the world. Our hard-to-find skill sets, continuous interaction with international thought leaders and participation in technical programs to enable knowledge creation, positioning Biocons R&D for challenging biopharmaceutical development.