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公司介绍 :
Hikal is a CDMO partner to global companies with 35 + years of rich experience in custom process development, manufacturing, custom synthesis, and APIs. Our CDMO Capabilities We offer comprehensive end-to-end CDMO services, supporting pharmaceutical and biotech innovators from pre-clinical development through to commercial manufacturing. ✅ Our Core Strengths Custom Synthesis & Process Development • Expertise in developing scalable, cost-effective, and robust chemical processes tailored to client needs. • Analytical Method Development & Scale-Up • Advanced analytical capabilities ensure product quality, regulatory compliance, and seamless scale-up. API, Intermediates & Specialty Chemicals • Proven experience in delivering high-quality active pharmaceutical ingredients and complex intermediates. Global Regulatory Compliance • Facilities and processes aligned with standards from US FDA, EMA, PMDA, and other major regulatory bodies. Advanced Infrastructure • Includes HPAPI containment, flow chemistry labs, and state-of-the-art manufacturing suites. 🌍 Global Reach & Regulatory Compliance Markets Served: US, EU, Japan Facilities: Six sites in India, including FDA- and GMP-compliant plants Certifications: USFDA, EU GMP, PMDA approvals for multiple sites. ⚗️ Technology Platforms Hikal applies a broad toolbox of advanced chemistries: Chiral Chemistry Biocatalysis Energetic Chemistry Solid-State Chemistry Continuous Manufacturing / Flow Chemistry Including liquid-liquid extraction systems for commercial APIs 🌱 Strategic Positioning Benefiting from the China-plus-one strategy, Hikal attracts global innovators seeking to diversify supply chains. Focused on low-carbon technologies, cost-effective manufacturing, and transparent project management
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