At Granules, we think that customer satisfaction is the key to success for any organization.
In addition to being price competitive, we believe service and quality to be integral in enhancing partner satisfaction. Customer centricity lies strong within our core, resulting in lasting customer relationships. We believe in strategic partnerships that exist due to customers’ beliefs in our broad internal product development capability, reliability, transparency and service.
Partnerships with leading players in the US, Europe and other regulated markets
Dossiers/ANDAs for APIs and finished dosages, which can be repacked and marketed by customers under their own brand name
Access to value-added products, such as rapid-release caplets and bi-layer tablets
Strong technical and operations team to develop and implement process efficiencies
Strong R&D team to work on developing and commercializing products with inherent complexities
At Granules, we have progressively invested in expanding capacities to leverage economies of scale, and ensure sufficient supply to our customers.
We are among the world’s largest quality-conscious API manufacturers, by volume. We also possess the largest PFI facility in the industry, along with one of the largest finished dosage capacities, globally. Our focus on process innovation helps us leverage our scale, which ultimately drives value for our customers.
Our expertise in large-scale manufacturing is demonstrated through industry leading six ton PFI batch size, which gives us a sustainable competitive advantage. The large batch size ensures lower testing costs for our customers and more consistency in production. Our finished dosage facility has an installed capacity of 18 billion doses per year, one of the world’s largest single-site capacities.
Quality and Compliance
Successful integration of appropriate Global Quality Standards at each phase of product development life cycle coupled with constant quality risk assessment and risk mitigation processes has differentiated Granules from the rest of competitors, and helped us stay ahead.
Meticulous assessment of applicable requirements, combined with a proactive approach for implementing quality and regulatory standards have proven to be a successful model for us and our clients.
The quality function at Granules is managed by highly qualified professionals with diverse experience in working with leading agencies across the globe (U.S., Canada, EU, Latam, BRIC and Asia Pacific countries, among others), continual improvement processes, problem solving and total quality management tools and techniques.
Quality is reinforced at every aspect of our business. The entire Product Life Cycle is integrated with Continual Quality Improvement philosophy, which is constantly refined to absorb every opportunity to make it more robust and flexible,while complying with the applicable standards. In addition, we also ensure that quality standards are met in the processes, procedures and products of our partnership networks. The manufacturing facilities adhere to rigorous quality framework and assurance procedures.
At Granules, we could successfully demonstrate the integration of quality concepts into development, commercialization, control of critical process parameters and critical quality attributes, control of outsourcing activities (raw materials etc.) and so on. The successful integration and compliance levels were indeed reflected in many regulatory and client audits, and assisted us to stay ahead in the curve. Granules actively works with all vendors and service providers to stay compliant at all times and to continuously explore the opportunities for improvement.
The quality standards are harmonized across the functions with a common goal of achievable and flexible standards, yet fully complying with the national and international regulatory and quality standards. The quality systems are synchronized to meet the global quality and regulatory standards. The basic standards considered for Quality System design includes ICH Q7, ICH guidelines on Quality, Regulatory and Safety, 21CFR Part 210, 211, Part 11, EU GMPs, prescribed cGMPs by WHO, TGA, TPD, ANVISA, Cofepris and MCC, among others.