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.

Global regulatory filings and support.

Globally Recognized Quality Standards

Coral's facility has been successfully inspected and approved by major international regulatory authorities including the US FDA, European Union, EDQM, and WHO on multiple occasions, demonstrating our commitment to maintaining the highest quality standards.

Comprehensive Regulatory Compliance

Our manufacturing site is certified by Indian health authorities (both state and central) and holds official written confirmation from India's central drug regulator certifying compliance with European Union cGMP standards.

Established Quality Management Systems

Proudly ISO 9001 certified for over a decade, ensuring consistent quality processes, with ISO 14001 environmental management certification currently in progress.

Extensive Drug Master Files Portfolio

Global filings across multiple product lines, with complete Drug Master Files and Technical packages available for all products to facilitate seamless regulatory submissions.

Strategic Global Market Authorizations

Established regulatory presence in key pharmaceutical markets including US FDA Drug Master Files (with GDUFA fees paid), European Pharmacopoeia (CEP) certifications, and approvals in Brazil, Australia, Korea, Taiwan, and numerous other international markets.

Dedicated Regulatory Partnership

Full-spectrum support through every stage of clients' regulatory journeys, from initial filing strategies to ongoing maintenance and timely updates, ensuring continuous market access and compliance.

Manufacturing quality controls.

Each step of production is carefully designed, tested, and validated to maintain the highest quality and reproducibility across batches. Our in-process checks ensure that any deviations are detected and addressed immediately.

Using state-of-the-art techniques, we conduct comprehensive analytical testing to confirm identity, purity, and potency. These methods provide highly accurate, reliable, and reproducible data for every batch.

Every quality control activity is meticulously recorded, allowing complete traceability and transparency. This ensures regulatory compliance while also providing valuable data for continuous improvement.

Our proactive quality systems enable early detection and quick resolution of any variations, preventing costly delays and ensuring product integrity.

We employ data-driven methodologies to analyze trends, optimize processes, and minimize variability—delivering APIs with unmatched consistency and performance.

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.

Bringing audit excellence and regulatory compliance to every phase of API development.

Proven Regulatory Success

Regular inspections by US FDA, EMA, and global authorities with consistent approvals.

Client Audits

A strong track record of positive outcomes with key pharmaceutical partners.

Continuous Quality Improvement

Ongoing enhancements to meet and exceed industry standards.

QUALITY assurance

Uncompromising quality, unwavering compliance.

A robust quality management system.

Global regulatory filings and support.

Globally Recognized Quality Standards

Comprehensive Regulatory Compliance

Established Quality Management Systems

Manufacturing quality controls.

Validated Processes

Advanced Analytical Testing

Thorough Review & Documentation

Rapid Issue Resolution

Statistical Quality Analysis

Reliable, high-quality API production at our core.

Bringing audit excellence and regulatory compliance to every phase of API development.

Proven Regulatory Success

Client Audits

Continuous Quality Improvement

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