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Biocon Malaysia

Biocon has brought affordable cancer and insulin therapeutic options to patients in Malaysia through a strategic partnership between Duopharma Biotech Berhad, Malaysia’s leading pharmaceutical company. The award of a RM300 million contract to Biocon Sdn Bhd and Duopharma Marketing Sdn Bhd to supply locally produced Insugen (recombinant human insulin) and the successful launch of Basalog One (Insulin Glargine pen) as well as Zuhera (Trastuzumab) have positioned Biocon as an innovative and progressive company in Malaysia. The partnership of Biocon and Duopharma Biotech has established both these companies as key players in the diabetes and cancer markets, with the government, healthcare professionals and patients.

Through subsidiary Biocon Sdn Bhd, Biocon has set up Asia’s largest integrated Biocon’s insulin manufacturing and R&D facility in Malaysia with an investment of USD 300 million. This is the largest foreign investment in biotechnology in Malaysia and reflects Biocon’s commitment to serve patients in different parts of the world. The site houses a state-of-the-art R&D center and highly automated Drug Substances and Drug Products facilities for manufacturing vials, cartridges and syringes.

Commercial operations of the Johor facility commenced in 2016 and Biocon’s recombinant human Insulin is the first locally manufactured biosimilar product approved for sale in Malaysia. The supply of insulins in Malaysia has provided a good base for the state-of-the-art manufacturing facility in Johor to operate economically. This provides Biocon with the foundation to explore export opportunities to bring affordable insulin therapies from its Malaysian plant to the rest of the world.

The Malaysia facility has regulatory clearances from the health authorities of the U.S. and EU.

Regulatory Clearances from Global Health Authorities

01 Apr, 2020 Biocon's Insulin Manufacturing Facility in Malaysia Receives EIR from U.S. FDA with Voluntary Action Indicated (VAI) Classification, Inspection Stands Closed Download Pdf
22 Aug, 2019 Biocon's Malaysia Insulin Glargine Manufacturing Facility Receives EU GMP Certification, Provides Fillip to its Capacity Download Pdf


Biocon Sdn. Bhd.,
No. 1, Jalan Bioteknologi 1,
Kawasan Perindustrian SiLC,
79200 Iskandar Puteri, Johor,

T +607-5600000
E: queries.malaysia@biocon.com

For Job Opportunities at Biocon Malaysia
write to careers.malaysia@biocon.com

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Press Release
Biocon's Insulin Manufacturing Facility in Malaysia Receives EIR from U.S. FDA with Voluntary Action Indicated (VAI) Classification, Inspection Stands Closed
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