API R&D
At Wanbury our R&D is the engine that powers groundbreaking advances in global healthcare. We transform ideas into world-class Active Pharmaceutical Ingredients (APIs), meeting today’s needs and setting tomorrow’s standards.
Strategic Planning & Feasibility
From Vision to Viable Solutions
We align our R&D strategy with business goals and regulatory trends, prioritizing new APIs with actionable plans. Our feasibility assessments harness comprehensive literature reviews, advanced computational tools, and deep technical expertise to design synthetic routes that are both technically sound and economically robust.
Process Development: Engineering Breakthroughs
Innovate, Validate, Optimize
- Route Design: Develop scalable, safe, and sustainable synthetic pathways for APIs.
- Raw Material Procurement: Ensure uncompromised quality and traceability through integrated SAP systems.
- Proof of Concept: Validate innovative routes with pilot API samples that meet rigorous testing benchmarks.
- Process Optimization: Enhance yield, purity, and cost-effectiveness using DOE and Quality by Design methodologies.
- Impurity Profiling: Characterize and control impurities—including GTIs and nitrosamines—to secure product integrity.
- Analytical Method Development: Collaborate with Analytical R&D to craft precise HPLC, GC, and LC-MS/MS methods.
Technology Transfer & Scale-Up
From Lab Bench to Global Manufacturing
- Seamless Transfer: Collaborate with Manufacturing and QA teams to transfer validated processes, supported by stringent risk assessments per ICH Q9 and M7.
- Pilot-Scale Synthesis: Produce API batches in kilo labs for clinical trials and stability studies, bridging innovation with real-world application.
- Process Validation: Confirm reproducibility and compliance with cGMP in state-of-the-art manufacturing facilities.
Quality & Regulatory Excellence
Setting the Global Benchmark
- Rigorous Standards: Uphold cGMP, ICH, and EHS guidelines in every process.
- Impurity & Stability Control: Monitor impurities and perform ICH Q1A-stability studies to define optimal shelf-life and storage conditions.
- Comprehensive Documentation: Maintain meticulous records for IP protection and global regulatory submissions, ensuring audit-readiness and robust dossier preparation for agencies like the FDA, EMA, PMDA, and Health Canada.
Operational Rigor & Sustainable Innovation
- Laboratory Excellence: Implement 5S standards and ALCOA+ principles to guarantee data integrity and operational efficiency.
- Equipment & Sample Management: Calibrate and qualify instruments on a strict schedule, with detailed logs supporting continuous improvement and audit trails.
- Proactive Risk Management: Employ FMEA and CAPA methodologies to mitigate risks, while integrating green chemistry initiatives to minimize our environmental footprint.
- Collaborative Culture: Foster cross-functional partnerships and continuous training, ensuring every innovation is safely and effectively translated into real-world impact.
Formulation R&D
At Wanbury, our state-of-the-art Formulations R&D centre epitomizes our commitment to pharmaceutical excellence. Dedicated exclusively to Quality and Formulation Development, our facility brings together expert teams who drive breakthrough research and transform innovative ideas into impactful therapies.
Our professionals, each holding advanced degrees in Life Sciences and Pharmaceutical Science, blend rigorous scientific excellence with practical insights. They ensure that every formulation not only adheres to the highest standards of safety, efficacy, and regulatory compliance but also sets new benchmarks for global healthcare.
General Administration
We streamline operations to ensure agile project management and optimal resource utilization. By coordinating cross-departmental functions seamlessly, we enable rapid decision-making and foster a culture of efficiency and innovation. Our proactive approach ensures that every process is optimized to support strategic growth and exceptional performance.
Quality Control
Our state-of-the-art Quality Control lab is divided into a Wet Chemistry section, where meticulous sample preparation is carried out, and an Instrumentation section, where precision analytical testing is performed. Equipped with advanced instruments—a few examples are dual Agilent HPLC systems, ElectroLab dissolution testers, a Shimadzu UV-Visible spectrophotometer, Newtronics stability chambers, Metler and Wenser analytical balances, a Thermocambel disintegration tester, and a Systonic pH meter—our lab ensures every analysis meets the highest standards of accuracy and compliance.
Quality Assurance & Regulatory Affairs
Our Quality Assurance team ensures strict adherence to GMP and regulatory standards—including those of the FDA, DCGI, DPCO, and NPPA—by conducting regular vendor audits, managing product approvals and recalls, and maintaining rigorous document control. We oversee change controls, risk assessments, corrective actions, tracking licenses, regulatory updates, and approving product artwork and packaging, ensuring every facet meets our uncompromising standards of quality and safety.
Analytical Method Development/Validation
Our R&D team conducts method development and validation, essential to our rigorous Drug Development and Chemistry, Manufacturing and Controls (CMC) processes. They ensure the analytical methods used to assess a drug’s identity, purity, potency, and stability are accurate, precise, and reliable. This rigorous process—critical for confirming the quality, safety, and efficacy of our products—plays a pivotal role during the technology transfer of new formulations to CMO sites (Contract Manufacturing Organizations).
By systematically evaluating and optimizing methods for sensitivity, specificity, and robustness, we integrate these validated techniques into our product testing specifications, ensuring that every attribute is measured within our medicines.
Formulations Development
At Wanbury, more than half of our flagship branded formulations are conceived, developed, and successfully commercialized by our Formulations R&D department.
This process blends an active drug with excipients through pre-formulation studies, design, testing, technology transfer, manufacturing, and stability testing to produce a stable, bioavailable, and effective final product.
Process & Equipment’s
Our Formulations & Development facility is outfitted with state-of-the-art manufacturing equipment designed for precise formulation trials and pilot-scale batch production. This advanced suite includes high-performance tablet compression and coating machines from Cadmac and Teksai Kraft Engineering, a Rapid Mixer Granulator by Saral Engineering, an innovative Octagonal Blender from Gangson Ltd, and sophisticated liquid syrup/drops stirrers and homogenizers from Remi Ltd, among several other cutting-edge instruments—all integral to our commitment to excellence and reproducibility in drug development.
Beyond Formulation’s
Our Formulations R&D team further enhances our API business by developing and commercializing a variety of DC granules of Metformin Hydrochloride, available in multiple optimized concentrations. In addition, our agile approach to product development has led to the successful creation and commercialization of over 15 innovative products in the past two years, with several promising candidates currently in development and verification stages.