The PolyPeptide Group has six operational GMP facilities, two in the USA (Torrance and San Diego), three in Europe (Sweden, Denmark, and France), and one in India (Mumbai). All of these facilities are devoted exclusively to the manufacture of active pharmaceutical ingredients (APIs) based on peptides and related substances. This diversity brings an unequalled breadth and depth of knowledge and experience to the Group and provides our customers with the assurance of success for any peptide manufacturing project undertaken. We take pride in our extensive experience in peptide synthesis and purification as well as in regulatory affairs.
The PolyPeptide Group offers a comprehensive range of peptide chemistries including classical solution phase, Boc- and Fmoc solid phase as well as hybrid approaches. The group owns an extensive range of large-scale chromatographic equipment, including some of the largest industrial HPLC columns available. The manufacturing capacity currently ranges from 25 milligrams to hundreds of kilograms with appropriately sized lyophilization capacity. Our regulatory specialists can support your project on both sides of the Atlantic.
The PolyPeptide Group has an outstanding track record of API approvals. Apart from numerous proprietary drug candidates, The PolyPeptide Group manufactures a wide selection of generic peptides including ACTH, Bivalirudin, Calcitonin, Carbetocin, Deslorelin, Desmopressin, Enfuvirtide, Eptifibitide, Felypressin, Gonadorelin, Goserelin, GRF(1-29) amide, Leuprolide, Octreotide, Oxytocin, PTH (1-34), Somatostatin and Arg-Vasopressin. New generic peptides are always in development. These APIs are found worldwide in over 50 registered drug products. Our facilities have been subjected to 6 successful pre-approval inspections by the FDA within the last few years.
We are the company with the proven record of taking peptides from the laboratory bench top to approval and beyond. Please contact us today at www.polypeptide.com.