Ami Polymer Pvt. Ltd

Ami Polymer : Enabling Healthcare

Ami Polymer is a global leader in the design and manufacture of high-purity silicone and polymeric solutions, specifically engineered for the most regulated environments in the Biopharma, Pharmaceutical, Medical, and Life Sciences sectors. Established in 1998, we have evolved from a specialized trading venture into a manufacturing powerhouse with a presence in the USA and Europe, serving over 3,000 customers worldwide.

Why Global Industry Leaders Choose Us:

World-Class Infrastructure: We operate extensive manufacturing facilities in Silvassa, India, featuring ISO Class 7 and 8 cleanrooms, along with a dedicated ISO Class 5 cleanroom specifically for medical implants.

Mission-Critical Reliability: Our engineering excellence is proven at the highest levels; our products have been utilized in Chandrayaan 2 & 3 space missions and within the Indian Navy.

Unrivaled Certification: We are the only Indian member of the Bioprocess Systems Alliance (BPSA), USA, and the only manufacturer in India holding NSF-51 certification for platinum-cured silicone resins.

Regulatory Rigor: Our products are supported by 7 USFDA-accredited Drug Master Files (DMF) and comply with USP Class VI, ISO 10993, and FDA 21 CFR 177.2600 standards.

Customization at Scale: With an in-house R&D center and advanced tooling division, we have developed a portfolio of over 5,000 customized products tailored to specific client requirements.

By partnering with the life sciences community, we provide innovative polymer solutions that ensure contamination control, fluid transfer efficiency, and affordable healthcare worldwide.

Commitment to Excellence & Innovation: We strive to set industry benchmarks through relentless research and development, empowering our team to achieve excellence in every facet of our business.

Safety & Biocompatibility: Our mission is to partner with the Life Sciences community by providing innovative polymer solutions that ensure patient safety and support affordable healthcare.

Regulatory Integrity: We maintain a strong focus on compliance, ensuring our products meet the highest global standards, including USP Class VI, ISO 10993, and USFDA Drug Master Files.

Quality & Purity: We utilize advanced cleanroom infrastructure (ISO Class 5, 7, and 8) to deliver products free from contamination, plasticizers, and phthalates for regulated environments.

Ethical & Sustainable Practices: We are dedicated to ethical business conduct and contribute positively to society through initiatives like environmental sustainability (Project ENPAS) and community support.

Customer-Centric Partnership: We don't just deliver products; we provide comprehensive documentation, traceability, and validation support to help our clients' quality and regulatory teams succeed.