State-of-the-Art Oncology API Manufacturing Facility
Zyphar’s Biopharmaceuticals operates a purpose-built, containment-focused manufacturing facility designed for the development and manufacture of high-potency and oncology APIs. Our infrastructure integrates advanced process equipment, robust containment systems, analytical capabilities, and quality systems to support operations from laboratory-scale development through commercial manufacturing.
The API manufacturing facility is located at Ranjangaon MIDC, Maharashtra, strategically located approximately 60 km from Pune. The facility is spread across 6,456 sq. ft., with a constructed area of 5,290 sq. ft. encompassing dedicated blocks for Oncology API manufacturing, Quality Control, Quality Assurance, warehousing, administration, and essential utilities. To support our growing manufacturing and development capabilities, an additional 10,000 sq. ft. Warehouse and R&D facility was commissioned in 2024, further strengthening our infrastructure and operational capacity.
Process Safety
At Zyphar’s Biopharmaceuticals, process safety is an integral part of our drug development and manufacturing approach. Our experienced scientists possess specialized expertise in identifying process hazards, assessing risks, and developing robust and scalable manufacturing processes.
We evaluate the robustness of every developed route at an early stage by systematically identifying potential hazards, assessing associated risks, and implementing appropriate controls. Process conditions are continuously reviewed and optimized to ensure safer, reliable, and commercially viable operations at plant scale. Wherever possible, we focus on eliminating or minimizing hazardous conditions and replacing unsafe operations with inherently safer alternatives.
Our team conducts comprehensive process investigations supported by detailed monitoring of reaction kinetics, thermodynamics, and critical process parameters. The resulting data enables systematic process optimization, supports scale-up decisions, and strengthens subsequent risk assessments.
Through a proactive, science-driven approach to process safety, we aim to deliver processes that are not only efficient and scalable, but also safe, controlled, and sustainable for commercial manufacturing.
Analytical & Regulatory Expertise
Our analytical team combines experienced laboratory professionals with specialized expertise in handling advanced analytical instrumentation and supporting complex testing requirements. Our dedicated method development and validation team brings extensive experience in developing, optimizing, and validating analytical methods to ensure robust product specifications, reliable analytical performance, and consistent regulatory compliance.
At Zyphar’s Biopharmaceuticals, our quality and analytical systems are designed to operate in accordance with applicable GMP, ISO and ICH guidelines, along with relevant regulatory requirements. Through a science-driven and compliance-focused approach, we ensure that our analytical methods, specifications, testing practices, and quality systems consistently meet the requirements of our customers and applicable regulatory authorities.
Manufacturing Infrastructure
- Stainless Steel Reactors up to 1,200 L capacity
- Glass Reactors in 50 L, 100 L, 200 L and 300 L capacities
- Receiving, charging and storage vessels
- Condensers, vacuum systems and controlled heating/cooling systems
- Chillers and temperature-controlled process systems
- Solvent recovery systems
- Scrubber systems for the safe control and neutralization of hazardous and toxic vapours generated during oncology API manufacturing
- State-of-the-art Category IV & V containment facility
- Stainless Steel Isolators for controlled handling of potent and cytotoxic materials
- Glove Box technology for high-potency pharmaceutical substances
- PAPR systems integrated with HEPA filtration technology
- Closed powder transfer and closed handling systems
- Vented Balance Enclosures (VBEs) for controlled dispensing and protection against airborne cytotoxic powders
- Local Exhaust Ventilation (LEV) systems
- OEL/OEB-based containment strategies
- Comprehensive PPE management and personnel protection systems
- Air monitoring and environmental controls
- Agitated Nutsche Filter Dryers (ANFD)
- Pressure Nutsche Filters
- Centrifuges
- Filter cartridges and vacuum filtration systems
- Decanters, where applicable
- Closed transfer systems for controlled material movement
- Vacuum Tray Dryers (VTD)
- Rotary Cone Vacuum Dryers (RCVD)
- Controlled vacuum and temperature conditions for sensitive and high-potency APIs
- Multi Mills
- Sifters
- Blenders
- Filtration systems
- Controlled material handling and transfer systems
- Dedicated R&D and Process Development laboratory
- Capabilities ranging from gram-level development to kilo-level process development
- Process optimization, scale-up and technology-transfer capabilities
- Support for process understanding, robustness assessment and manufacturing scale-up
Our Quality Assurance function is supported by established systems for:
- Batch Record Management
- Documentation Management
- Change Control
- Deviations, CAPA and investigation management
- Validation and qualification
- Stability Management
- Controlled document systems
- Quality risk management
- Data integrity and GxP compliance
- Autoclaves
- Incubators
- Laminar Airflow systems
- Microbiological testing and environmental monitoring capabilities
- Water pre-treatment systems
- Purified Water generation and distribution infrastructure
- Temperature and environmental control systems
- Vacuum, compressed air and other critical process utilities
- Effluent Treatment Plant (ETP) with a capacity of approximately 2,000 L/day
- Scrubber systems for hazardous vapour control
- Controlled waste handling systems
- Environmental and process monitoring systems
- Semi-automated, electronically controlled operating systems
- Systems designed in accordance with GAMP principles
- Electronic monitoring and control of critical process parameters
- Controlled and traceable manufacturing operations
Annual Oncology API Manufacturing Capacity: up to 18,000 kg/year – Capacity is dependent on the product, process, batch size, containment requirements and manufacturing campaign.