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Formulation & Fill-Finish
The launch of human insulin in 2004 represented Biocon’s foray into the aseptic formulations space. In order to facilitate the complex formulation requirements for insulin with different pharmacokinetic profiles, and also to support the extensive pipeline of protein, peptide and antibody products, Biocon commissioned its first aseptic formulation and fill-finish facility. This facility is equipped to deliver liquid and lyophilized vials, cartridges for injection devices (pens) and pre-filled syringes. The multi-product facility can also cater to similar requirements from clients and partners and is designed to the highest of international standards, especially since protein and antibody products, unlike small molecules, cannot be terminally sterilized.
This facility has been approved by several National Regulatory Agencies around the world and fulfills the global demand for Biocon’s sterile injectable products. |
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