PolyPeptide Group

PolyPeptide Group is a leading Contract Development & Manufacturing Organization (CDMO) that specialises in the production of peptide- and oligonucleotide-based active pharmaceutical ingredients.

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PolyPeptide-Group-1.jpeg

Description

PolyPeptide Group is a global contract development and manufacturing organisation (CDMO) specialising in peptide-based active pharmaceutical ingredients (APIs).

Established in 1952, PolyPeptide Group has grown into a leading manufacturer of peptide-based APIs, operating facilities across Europe, the United States, and India. The company has produced over 1,000 GMP-quality peptides, demonstrating deep technical expertise and a commitment to quality. In 2021, PolyPeptide expanded its product range to include oligonucleotide APIs, further broadening its service offerings. With a diversified customer base that includes large pharmaceutical companies, biotech firms, and academic institutions, PolyPeptide supports clients throughout the entire drug development process, from pre-clinical stages to commercial manufacturing.

Key Products and Services:

  • GMP Compliance: Ensuring all products meet stringent Good Manufacturing Practice standards.
  • Pre-GMP Development: Assisting clients in the early stages of product development before GMP standards are applied.
  • Production: Manufacturing peptide and oligonucleotide APIs at various scales to meet client needs.
  • Quality Assurance and Control: Maintaining high-quality standards through rigorous testing and validation processes.
  • Regulatory Support: Guiding clients through the complex regulatory landscape to achieve product approvals.
  • Commercial Manufacturing: Providing large-scale production capabilities for commercial products.
  • Custom Research and Development: Offering tailored solutions for research-grade peptides and radiolabeled peptides.
  • Generic Peptides and Cosmetic Peptides: Supplying a range of generic and cosmetic peptide products.
  • Individualized Peptides and Oligonucleotides: Developing personalized peptide and oligonucleotide solutions to meet specific client requirements.

PolyPeptide Group's mission is to assist customers in securing regulatory approvals and successfully launching and commercialising their products. With core values of innovation, excellence, and trust, the company fosters an agile, open, and collaborative work environment, continuously developing its organisation and sharing best practices across its global operations.

Certification
Canada Health Canada, United States FDA, South Africa MCC, China NMPA, Europe EMA, France ANSM, Russia Roszdravnadzor, Japan PMDA, South Korea MFDS, Denmark DKMA, Sweden MPA, Mexico COFEPRIS, WHO, India CDSCO, Belgium FAMHP

Capabilities

Contact Information

Website
Address
P.O. Box 30089 , Limhamn, SE-200 61 , Sweden, Sweden
Zip/Post Code
90503

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