Small Molecule API CDMO Service

Small Molecule API CDMO Service

Protheragen-ING Lab offers comprehensive small molecule active pharmaceutical ingredient (API) contract development and manufacturing organization (CDMO) services. Our mission is to accelerate your drug development process with our expertise, cutting-edge technology, and unwavering commitment to quality. We provide end-to-end solutions tailored to meet the unique needs of your project, ensuring seamless integration from development to commercial production.

Our small molecule API CDMO capabilities

Custom Synthesis and Process Development

Our seasoned chemists and process engineers excel in custom synthesis and process development. We work closely with you to understand your specific requirements, enabling us to:

  • Design and optimize synthetic routes: We employ advanced techniques to develop efficient, scalable, and cost-effective synthetic pathways.
  • Develop robust processes: Our focus on process robustness ensures consistent quality and reproducibility, crucial for regulatory approval and commercial success.
  • Scale-up and tech transfer: We facilitate seamless scale-up from laboratory to pilot plant to full-scale production, ensuring process consistency and reliability.

Analytical and Regulatory Support

Quality and compliance are at the heart of our services. Our analytical and regulatory support includes:

  • Analytical method development and validation: Our state-of-the-art analytical laboratories provide comprehensive method development, validation, and transfer services.
  • Regulatory submissions: We assist with the preparation and submission of regulatory documents, ensuring compliance with global regulatory standards.
  • Stability studies: We conduct rigorous stability testing under ICH guidelines to ensure the long-term stability and efficacy of your API.

cGMP Manufacturing

Our manufacturing facilities are designed to meet the highest standards of cGMP. Key features include:

  1. We handle a wide range of production scales, from grams to metric tons, ensuring flexibility and efficiency.
  2. Our facilities are equipped with state-of-the-art technologies, including continuous manufacturing and high-containment systems for potent APIs.
  3. Our robust quality management system ensures every batch meets the stringent quality requirements, backed by comprehensive documentation and traceability.

Formulation Development

Beyond API production, we offer formulation development services to transform your API into a finished drug product. Our formulation capabilities include:

  • Pre-formulation studies: We conduct detailed physicochemical and pre-formulation studies to understand the properties of your API.
  • Dosage form development: We specialize in developing various dosage forms, including oral, injectable, and topical formulations.
  • Scale-up and manufacturing: Our expertise in scale-up ensures that your formulation is ready for clinical trials and commercial production.

Why choose us as your small molecule API CDMO?

  • Extensive experience in developing and manufacturing a wide range of small molecule APIs.
  • Cutting-edge analytical capabilities and state-of-the-art equipment to ensure product quality.
  • Commitment to safety, environmental sustainability, and regulatory compliance.
  • Flexible and responsive project management to meet your specific needs and timelines.
  • Competitive pricing and a reliable supply chain to support your drug development and commercialization efforts.

Partner with Protheragen-ING Lab for your Small Molecule API CDMO needs. Contact us today to learn how we can support your project from concept to commercialization.