BIOCON SDN BH

COMPANY CLASSIFICATION

Manufacturer (Factory)

COMPANY INTRODUCTION

Biocon Sdn Bhd is a subsidiary of Biocon Limited, a leading global biopharmaceutical company based in India. Established in Johor, Malaysia, Biocon Sdn Bhd operates Asia's largest integrated insulins manufacturing facility.

Key Details of the Company:

Location: Located in the Bio-XCell biotechnology park in Iskandar Puteri, Johor, Malaysia.

Core Business: The company focuses on the research, development, and high-tech manufacturing of affordable, high-quality biosimilars, specifically recombinant human insulin and insulin analogs such as Glargine and Aspart.

Facility Significance: This state-of-the-art facility is equipped with advanced technology for drug substance and drug product manufacturing, as well as quality control and research and development laboratories. It is designed to meet stringent global regulatory standards.

Global Approvals: The manufacturing site has received approvals from major international regulatory bodies, including the US Food and Drug Administration (US FDA), the European Medicines Agency (EMA), and the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia.

Market Reach: Biocon Sdn Bhd manufactures and supplies insulins to patients in Malaysia and exports its products to over 100 countries globally, playing a critical role in addressing the global diabetes epidemic.

Conclusion:

Biocon Sdn Bhd is a highly advanced biotechnology factory (manufacturer) with integrated research and production capabilities, and is not a trading company.

BIOCON SDN BHD in Malaysia primarily manufactures and contributes to the global supply of various biopharmaceutical products. The key products associated with their operations include:

Recombinant Human Insulin

Insulin Glargine

Insulin Aspart

Insulin Lispro

Other Biosimilar Biologics which are manufactured at their facility for global distribution.