High Potent API LP High Potent API LP

Industry-leaders in High Potent API

Development and Manufacturing

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About Aurigene Pharmaceutical Services

Aurigene Pharmaceutical Services is a well-established integrated CRO/CDMO, with end-to-end capabilities in drug discovery, development, and manufacturing of APIs and formulations. We have more than 20 years of legacy in accelerating breakthrough discoveries for global pharma and biotech companies. Our focus on scientific expertise, technology, innovation, and problem-solving, combined with our strong commitment to sustainability, compliance, and intellectual property protection, has established us as a preferred partner for a number of global pharmaceutical and biotechnology firms. We believe in cultivating and nurturing long-term relationships through our innovative work that emphasizes speed, adaptability, communication clarity, and collaboration.

HPAPI Development and Manufacturing

Looking for a one-stop solution for handling your HPAPI projects? Aurigene Pharmaceutical Services is experienced in providing end-to-end solutions in High Potent API (HPAPI) development and manufacturing (up to OEL 0.1µg/m³), for nearly two decades. With a rich portfolio of projects that are handled from early development to commercialisation phases, our teams of scientists, toxicologists, regulatory and analytical experts are incredibly well-equipped to address the drug innovation needs of our global clients.

Oligonucleotide Synthesis

How Aurigene Pharmaceutical Services can Support your High Potent API (HPAPI) Development and Manufacturing projects

  • Stringent safety practices and containment control philosophy
  • cGMP isolator systems (up to OEL 0.1µg/m³) for highly potent raw materials, intermediates and APIs including charging, filtration, drying, dispensing and packaging
  • Manufacturing of complex substances from gram to multi-kilogram quantities
  • Isolator consists of sampling, dispensing, reaction, isolation and drying process.
  • High containment closing tool kit
  • Negative pressure value inside the isolator
  • AI highly skilled scientific team in both discovery, development and analytical research domains

Aurigene Advantage

  • 20+ years of experience in accelerating drug innovation

  • Highly experienced scientific and scale-up teams

  • Global accreditations

  • Dedicated manufacturing setup withpilot and commercial scale capability

  • Industry-leading expertise in discovery and CMC services

  • Strong and sustainable Operations

  • Advocates of long-term partnerships

  • Flexible services and business model

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