QUALITY assurance
Uncompromising quality, unwavering compliance.
From raw materials to final delivery, our quality-first approach ensures consistency, compliance, and confidence in every API we produce.
A robust quality management system.
At Coral Drugs, quality isn’t just a requirement—it’s a commitment. Our comprehensive Quality Management System (QMS) ensures:
- Consistency & Compliance: Every step, from raw materials to final delivery, follows stringent quality controls.
- Data-Driven Decisions: Advanced analytics and real-time feedback improve accuracy and efficiency.
- Operational Excellence: We continuously identify and eliminate bottlenecks to optimize production.
Regulatory & Quality Excellence
Regulatory Inspections
Our manufacturing facility is routinely inspected by top regulatory authorities, including the US FDA, EU agencies, EDQM, WHO, and India’s CDSCO and State FDA. These inspections confirm full compliance with current Good Manufacturing Practices (GMP) and reinforce our reputation for regulatory excellence.
Customer Audits
We are regularly audited by global pharmaceutical companies who rely on us for transparency, reliability, and product quality. Our consistent performance in these audits reflects the high level of trust placed in us by customers across diverse markets.
ISO-Certified Quality Systems
We are ISO 9001 certified for robust quality management systems that support consistency and continual improvement. Our ISO 14001 certification is currently underway, underscoring our commitment to responsible, environmentally sound manufacturing.
Sustained Supply of High-Quality APIs
Decades of operational reliability and technical expertise allow us to ensure uninterrupted supply of premium APIs. We prioritize consistency and long-term dependability in every aspect of our production and delivery.
Global Regulatory Filings & Market Access
Our extensive DMF portfolio covers major markets worldwide, including the US (GDUFA-compliant), Europe (via CEP), Brazil, Korea, Taiwan, and beyond—enabling our partners to achieve efficient and compliant market entry.
Manufacturing quality controls.
Reliable, high-quality API production at our core.
We deliver continuous, reliable, and high-purity APIs through:
- Vertically Integrated Operations: Full control over quality and supply chain.
- Advanced Production Planning: Ensuring efficiency and on-time delivery.
- Proactive Change Management: Effective handling of deviations and process improvements.
- Ongoing Equipment Qualification: Regular maintenance and validation for peak performance.
- Skilled Workforce: Continuous training to uphold the highest quality standards.
