Theon Lifescience is a leading sterile injectables manufacturer serving the world’s most regulated markets. We have a EuGMP, USFDA, TGA Aus, ANVISA, WHO-GMP, and ISO-compliant facility, delivering uncompromising quality standards & healthcare solutions at accessible prices.
Our cutting-edge technology, and large-scale production capacity is qualified for continuous sterile manufacturing for Lyophilized Inj, General Liquid Injection, Ampoules, PFS and Ophthalmic Formulations.
Our dedicated production lines for sterile injectable includes:
With a dominant focus on sterile formulations, we deliver world-class quality injectables and operate under cGMP-certified protocols, combining cutting-edge infrastructure, stringent quality systems, and regulatory excellence for patients, professionals, and partners across the world. Our facility spans 10.46 acres with a 4,55,000 sq. ft. injection block, designed in compliance with EU GMP, USFDA, TGA Aus, and ANVISA guidelines, ensuring smooth operations with minimal human intervention.
We Undertake The Technology Transfer For Liquid vials, Ampoules, PFS and Ophthalmic Generic Formulations.
All lines are qualified and ready for media fill in this month of May 2025.
Automatic Ampoule loading, washing machine, tunnel filling and sealing machine is qualified along with terminal sterilizer, labelling machine and Blister machine and complete Ampoule line set up is ready for operations.
Ophthalmic Filling and sealing Machine ROMACO (3 piece) is qualified and ready for operations
Aseptic Process Simulation Activity is Scheduled in May 2025 and is under process.
Our all areas of four lines: vial, ampoules, PFS, and Ophthalmic are Qualified for continuous sterile manufacturing.
Complete vial line starting from loading of vials, washing, 04 tunnel, filling and sealing is qualified along with Automatic Loading and un-loading system for Lyophilizer and lyophilizer is qualified and ready operations.
PFS Filling Machine is Under Qualification.
Manufacturing Vessel System Compounding and Holding 08 vessels are qualified for all four lines and ready for operations.
Media Fill activities will Be Completed in June 2025 Before Starting the Commercial Production.
We are a dedicated hub for formulation development and innovative sterile injectables, focused on driving global market readiness. Our expertise spans complex generics, novel delivery systems, and seamless technology transfer support.
We are specialized in manufacturing liquid vials, ampoules, lyophilized injectables, pre-filled syringes, and ophthalmic preparations. Our advanced technology transfer capabilities ensure regulatory compliance, and faster market entry for complex generics and novel formulations.
With a world-class infrastructure, we can produce high-volume, and reliable production. We can adjust to market demands because of our automation and process optimization, guaranteeing a reliable supply chain for both developing and heavily regulated international markets.
We are committed to build an eco-conscious manufacturing facility as our units are equipped with 100 KLD ETP and 50 KLD STP for wastewater treatment. From waste minimization to responsible sourcing of raw materials, every step reflects our dedication to sustainability.
Facility validated for stringent international regulatory requirements.
From robotic PFS filling to advanced compounding and vessel systems.
Focused on creating value for global partners through reliability and innovation.
21 CFR part 11 compliant systems with real-time monitoring and traceability.

Automated lines capable of handling millions of units annually.
Facility validated for stringent international regulatory requirements.
From robotic PFS filling to advanced compounding and vessel systems.
Automated lines capable of handling millions of units annually.
21 CFR part 11 compliant systems with real-time monitoring and traceability.
Focused on creating value for global partners through reliability and innovation.
Our objective is simple: to develop life-saving medications while also preserving the environment.
Our Globally Recognized Quality Standards and Certifications
Measurable Results Delivered with our Manufacturing Excellence
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Let’s discuss how Theon Lifesciences can support your pharmaceutical manufacturing needs with ethical innovation and global compliance.