1,50,000 sq. ft. of fully automated sterile manufacturing facility, built to meet EUGMP, USFDA, TGA Australia, Anvisa, WHO-GMP, and ISO standards for uncompromised quality.
Theon Lifescience’s manufacturing facility is a benchmark in precision, safety, and scalability. Situated over 10.46 acres and featuring a 150,000-square-foot sterile injectables block, our facility is engineered to deliver premium injectable solutions while keeping human intervention to a minimum. Each corner of the facility reflects its adherence to EUGMP, USFDA, TGA Australia, Anvisa standards, supporting flawless, sterile operations across every production line.
Equipped for optimal sampling, storage, and inventory control, our warehouse guarantees that raw materials and finished products are stored securely and precisely.
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Supported by 50 KLD and 100 KLD Sewage and Effluent Treatment Plants, our facility uses advanced water purification and monitoring to ensure strict water-quality standards.
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Advanced air handling with BMS integration, sustain a consistently controlled, aseptic environment, minimizing contamination risk and protecting product integrity.
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Essential utilities, including boilers, compressors, and power-backup systems, ensures continuous, and reliable manufacturing operations, through the production process.
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Quality Management System
Environmental Management
Occupational Health & Safety
At Theon Lifesciences, regulatory compliance is non-negotiable. Our facility is certified under EUGMP, USFDA, TGA Australia, Anvisa and WHO-GMP, and ISO standards, and all processes adhere to cGMP protocols.
We maintain 21 CFR part 11 compliant systems with real-time monitoring and traceability, guaranteeing product safety and quality. Media fill tests and aseptic process simulations have been conducted to validate all manufacturing lines, confirming readiness for commercial-scale production in regulated markets worldwide.
Advanced STP and ETP systems guarantee the safe treatment and reuse of water.
Harvested rainwater supports the preservation of natural water levels and the upkeep of landscaping needs.
Our automated processes optimize energy use, lessen waste, and lessen our environmental footprint.
Theon Lifesciences’ facility embodies a seamless coordination of scale, automation, compliance, and sustainability.
Our facility is capable of manufacturing millions of units each year across its array of sterile injectable lines.
Engineered and verified to satisfy strict international regulatory standards.
Automated and monitoring systems guarantee precision, reliability, and process integrity.
Sustainability is integrated into every facet of operations.
Let’s discuss how Theon Lifesciences can support your pharmaceutical manufacturing needs with ethical innovation and global compliance.