Biocon Biologics Malaysia site classified as VAI by USFDA
Bengaluru: Biocon has announced that the U.S. Food and Drug Administration (FDA) has classified Biocon Biologics' Insulins facilities in Johor Bahru, Malaysia as Voluntary Action Indicated (VAI).
This relates to the cGMP inspection conducted by the agency between September 15 – 27, 2024. The inspection scope had included several biologics manufacturing units comprising one (1) Drug Substance and one (1) Drug Product manufacturing units, one (1) Medical Device Assembly unit, one (1) Analytical Quality Control Laboratory, two (2) Microbiological Control Laboratories and two (2) Warehouses.
“Biocon Biologics remains committed to global standards of Quality and Compliance,” the Company Spokesperson said in a statement.
Biocon Biologics Limited, a subsidiary of Biocon Limited, is a unique, fully integrated, global biosimilars company. The Company has commercialized eight biosimilars in key emerging markets and advanced markets like U.S., Europe, Australia, Canada, and Japan. It has a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases.
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