Our State-of-the-Art Global Infrastructure
Cytonova Labs is a global pharmaceutical manufacturer specializing in complex Active Pharmaceutical Ingredients. With ultra-modern R&D hubs and high-capacity GMP plants across key regions, we combine cutting-edge science, robust quality systems, and reliable scale to keep critical therapies supplied worldwide.
Global API Manufacturing. Ultra-Modern R&D.
R&D & INNOVATION
MANUFACTURING RESPONSIBILITY
We bridge clinical lead discovery with industrial scale-up. Our R&D centers integrate molecular biology insights with flow chemistry and high-throughput screening to reduce lead times for complex synthesis programs.
Compliance is our foundation. We operate under a Zero-Tolerance quality framework, ensuring every gram of API meets internal purity specifications that often exceed national pharmacopeia standards.
- 280+ Dedicated Scientists
- 14 Lead Molecules in Clinical Support
- Advanced Impurity Profiling Lab
- 100% Zero-Waste Aqueous Discharge
- Continuous Air Emission Monitoring
- Ethical Supply Chain Audits
What "global scale" actually runs on: Standardized capabilities across our fourteen sites.
MANUFACTURING EXCELLENCE
Reactor scale standardized for clinical and commercial volume. 4,800 KL total volume.
CAPACITY
AUTOMATION
100% digital batch records (EBR) across every site in the global manufacturing network.
QUALITY
210+ in-line Process Analytical Technology (PAT) instruments for real-time monitoring.
LOGISTICS
38 qualified shipping lanes managing global cold chain delivery to 90 countries.
Who We Are
Leaders in Complex API Molecular Engineering
Cytonova Labs serves as a vital bridge between innovation and market, operating as a full-service CRO and CDMO. In our CRO capacity, we handle API discovery and analytical development; as a CDMO, we execute large-scale synthesis of high-potency molecules, ensuring robust API structural integrity.
What We Do
Integrated API Design & CDMO Services
We provide end-to-end support for Active Pharmaceutical Ingredients via our integrated model. Our teams focus on lead optimization and commercial scale-up of high-potency APIs for life-saving oncology therapies.
Global Reach: US, EU & Asia
Strategic API Authorization Across 50+ Nations
We enable international access to oncology APIs by aligning our CRO data and CDMO manufacturing exports with global pharmacopeia standards. Cytonova Labs maintains a compliant supply chain that meets the complex needs of healthcare systems globally.
API Quality, Compliance & Regulatory Strategy
Superior cGMP Assurance for Complex API Supply
Our global QMS ensures ICH compliance for all APIs, backed by rigorous CRO analytical oversight and CDMO process control. We provide sponsors with comprehensive CMC documentation.
HISTORY
1998 — First reactor line commissioned
Cytonova Labs begins production of a single anti-infective API.
2004 — First US FDA approval
Hyderabad site clears its first US FDA inspection.
2013 — Ningbo site acquired
Cytonova Labs acquires its first manufacturing sites in India and outside India.
2019 — Global headquarters opens in San Francisco
Establishing corporate and R&D strategy in the heart of biotech.
2024 — Network-wide digital batch records completed
All fourteen sites move to a unified electronic batch record system.
