Quality Assurance & Global Compliance

If there is one attribute to which we attach the utmost importance it is quality. Quality is considered paramount at all locations where we conduct development, manufacture, testing and distribution of pharmaceutical products. Our operations are driven by best-in-class technology and processes, abiding by major international regulatory approvals such as EU GMP, TGA Australia, Health Canada, approval from Nigeria, Sudan, Kenia, Philippines, Thailand, and WHO-GMP. In the API space we have PMDA Japan, EU, TGA, Health Canada and EUGMP.

Our commitment to implementing a robust quality management system is anchored in our determination to sustain a culture of operational excellence, meeting and exceeding the expectations of all stakeholders—including patients, healthcare providers, and global regulatory bodies. Putting patients first is our motto.

To maintain rigorous quality standards, every manufacturing site has well-defined procedures and automated systems in compliance with Current Good Manufacturing Practices (cGMP), WHO, PIC/S, and EU GMP guidelines. This guarantees that every commercial batch meets the most stringent international criteria for identity, purity, safety, and bio-equivalence.

Each site is staffed with qualified analytical chemists and quality assurance professionals guided by our centralized Corporate Quality Department (CQD) with the principle “One company one Quality”. CQD oversees the real-time translation of international GMP revisions into actionable standard operating procedures (SOPs), validation master plans, and qualification protocols with ALCOA++ as a mandatory requirement.

Furthermore, our adherence to quality extends across our entire supply chain. All vendor partners and raw material suppliers undergo periodic audits to ensure strict conformance with our internal and regulatory standards.