Temperature & Logistics

GDP-Compliant Logistics Operations We collaborate with specialized pharmaceutical logistics partners who are experienced in handling regulated medicines under Indian climatic conditions, including high ambient temperatures and humidity. All logistics activities are aligned with Good Distribution Practices (GDP) to ensure medicines are stored, transported, and delivered in a manner that maintains their quality and integrity. Standard operating procedures are in place to govern storage, packing, dispatch, transit, and delivery, with trained personnel overseeing each step of the logistics process. EU-GDP Certified Warehouse Infrastructure Our logistics framework includes access to EU-GDP certified warehouse facilities designed to support compliant pharmaceutical storage and distribution. These warehouses provide validated environments for both 2–8°C cold chain storage and controlled room temperature storage, supported by calibrated temperature control systems. To strengthen international supply reliability, we operate through two EU-GDP certified warehouse facilities located in Belgium and Bulgaria. These strategically positioned hubs enable compliant storage, consolidation, labeling (where applicable), and onward distribution of specialty medicines for Named Patient Programs. The warehouses operate under documented GDP procedures, including environmental monitoring, deviation management, access control, and regular quality reviews, ensuring product integrity prior to international shipment. Temperature Monitoring and Data Logging: Continuous temperature monitoring is implemented across storage and transportation stages to ensure uninterrupted temperature control. Shipments are supported by: Validated temperature-controlled and insulated packaging systems Electronic data loggers providing trip-based or real-time temperature data Pre-dispatch verification of packaging configuration Post-delivery review and documentation of temperature records Temperature data is reviewed upon receipt to confirm compliance with defined limits. Any temperature excursion is documented and evaluated through established risk assessment procedures, with appropriate actions taken in line with GDP requirements. Product Integrity, Traceability, and FMD Alignment Maintaining product integrity and authenticity is a key focus of our logistics operations. Where applicable, Falsified Medicines Directive (FMD)-aligned verification and traceability processes are followed to support product authentication and prevent the risk of falsified medicines entering the supply chain. These measures strengthen traceability, accountability, and patient safety throughout international and local distribution pathways. Risk Mitigation and Transit Management: Pharmaceutical logistics involves managing multiple variables, including transit delays, customs clearance, route variability, and seasonal climate challenges. We implement structured risk mitigation strategies to minimize the impact of such challenges. This includes contingency planning, partner coordination, shipment tracking, and proactive communication to ensure continuity of supply without compromising temperature integrity or product quality. Commitment to Quality and Patient Safety Through validated infrastructure, EU-GDP certified warehouse facilities in Belgium and Bulgaria, continuous temperature monitoring, data-driven oversight, and structured risk management, we ensure that medicines reach healthcare providers and patients in full compliance with manufacturer specifications, regulatory expectations, and patient safety requirements. Our temperature and logistics practices are designed to support safe, reliable, and compliant access to medicines for named patients, reinforcing our commitment to quality and responsible pharmaceutical distribution.