Biocon has made significant investments in building commercial scale, globally compliant manufacturing infrastructure across diverse technology platforms. Our state-of-the-art manufacturing facilities – both microbial and mammalian – are designed to conform to the most stringent cGMP guidelines, comply with international regulatory standards and meet client requirements worldwide. Our products are manufactured at scale for both developed and emerging markets in Bengaluru (India) and Johor (Malaysia).

Our investments in building global scale have led us to rank among the world’s Top 15 biomanufacturing companies. We are among the leading insulin producers worldwide and have one of the largest antibodies manufacturing capacities in South Asia.

The breadth and scale of Biocon’s manufacturing technologies encompass large-scale microbial fermentation, chemical synthesis, mammalian cell culture, protein & antibody purification, aseptic formulation and fill-finish. Our manufacturing facilities are designed to stringent cGMP standards and are supported by state-of-the-art process development and quality control laboratories and an efficient service infrastructure.

Our capabilities and technologies have helped us emerge as an end-to-end player with a strong pipeline of approved biosimilars.

Our investment strategy is to build capacity in a modular manner, in line with our projection of market opportunity.

Award-Winning mAbs Facility in Bengaluru

Our 350,000 sq. ft. mAbs Drug Substance (B3) facility in Biocon Park is one of the largest mAbs manufacturing facilities in India in terms of the built-up area of a single building/site. This is India’s first biopharma facility awarded by the International Society for Pharmaceutical Engineering (ISPE).

Malaysia: Center of Excellence (CoE) for Insulins

Biocon Biologics has created a Center of Excellence (CoE) for insulins in Malaysia with end-to-end capabilities to manufacture a broad portfolio of regular, basal and rapid insulins. The state-of-the-art insulins facility in Johor is the first and only biopharmaceutical sterile injectables facility in Malaysia to receive U.S. Food and Drug Administration (FDA) and European Medicines Agency approvals. More recently, Biocon’s biosimilar insulin Glargine made at Malaysia received a historic U.S. FDA approval as the ‘first interchangeable biosimilar’.

The 562,000 sq. ft. facility has been recognized as the first and largest integrated insulin manufacturer in Malaysia by the prestigious Malaysia Book of Records, which officially recognizes record-creating and record-breaking achievements in the fields of human endeavour, building & structures, transportation, arts & entertainment, business, sports & games, science & technology, nature etc. in Malaysia.

Our facility in Malaysia is Asia’s largest integrated insulins facility that manufactures Drug Substance and Drug Products in vials, cartridges and insulin delivery devices.