Premium Hemodialysis Solutions Manufacturer

Welcome to Alpine D Medics Pvt Ltd

At Alpine D Medics Pvt Ltd, we specialize in manufacturing high-quality hemodialysis concentrates, delivering reliable solutions for renal care across India. As a CDSCO-licensed facility, we uphold the highest standards of safety and efficacy, certified under ISO 13485:2016 by IAF-recognized bodies, with EGAC and LMS assessments ensuring global compliance. Our commitment to excellence is reflected in every product we produce, supporting dialysis centers and hospitals with precision-engineered concentrates that meet stringent regulatory requirements.

State-of-the-Art Infrastructure

Our Tiruppur-based facility features advanced infrastructure designed for seamless, contamination-free operations. We operate a dedicated RO and DM plant for ultra-pure water production, essential for hemodialysis solutions. The cleanroom environment is maintained by an AHU system with precise temperature and humidity control, ensuring optimal conditions throughout the manufacturing process.

Our production layout follows a unidirectional man-material flow, from raw material de-dusting and quarantine to approval, sampling, and dispatch. This includes specialized SS tanks for mixing and storage, segregated areas for production, packing, and finished goods quarantine. To promote sustainability, we integrate an ETP (Effluent Treatment Plant) for responsible waste management, minimizing environmental impact while adhering to all local regulations.

Unwavering Quality Assurance

Quality is at the heart of Alpine D Medics. Our QA and QC processes align fully with ISO 13485:2016 and CDSCO guidelines, incorporating rigorous validation at every stage—from raw material intake to final dispatch. Our in-house laboratories are equipped with state-of-the-art instrumentation for analytical testing, microbiology analysis, and chemical validation. We conduct comprehensive stability studies, microbial monitoring, and process validations to guarantee product integrity and patient safety.

Every batch undergoes multi-tiered checks, including environmental monitoring and documentation per GMP standards. This meticulous approach ensures our hemodialysis concentrates—such as acidic and bicarbonate solutions—deliver consistent performance, free from contaminants, and compliant with international pharmacopeial norms.

Our Certifications and Compliance

We proudly showcase our certifications as hallmarks of excellence and reliability:

• ISO 13485:2015 : Certifying our robust quality management system for medical devices, recognized globally for compliance and safety.​

• EGAC Accreditation : Affirming our adherence to international standards through the Egyptian Accreditation Council, ensuring credible and impartial assessments.​

• LMS Assessment Limited : Validating our certification processes with precision and integrity from this UK-based body, focused on ISO standards for medical manufacturing.​

• CDSCO License : Authorizing our operations under India's premier regulatory authority, guaranteeing product safety and efficacy in the medical device sector.​

These badges not only represent our achievements but also our ongoing dedication to the highest standards in quality assurance and regulatory compliance.

Partner with us for innovative, compliant renal care solutions that prioritize quality and reliability. Contact us today to learn more about our products and capabilities.

✓ ISO 13485:2016 IAF EGAC Certified     ✓ GMP Standards     ✓ Quality Assured Products     ✓ Regulatory Compliant     ✓ CDSCO Licensed