Manufacturing competences from R&D to commercial scale:

Multi Step Chemical Synthesis:

Solution Phase is Chemi’s core competence for large scale GMP production. R&D expertise on Solid Phase is available.
Multipurpose reactors and hydrogenators, vacuum dryers and filter dryers.

Down Stream Process:

from the purification of the crude to the release of the final API.
Reverse phase purification by High Performance Displacement Chromatography (HPDC), Ion Exchange Chromatography (IEx), Reverse Osmosis, Ultrafiltration, Freeze-Drying.

Generic & complex Generic peptides

Products at commercial and advanced scale:

US DMF EU DMF CEP
Octreotide
Leuprolide
Goserelin
Glatiramer US AND submitted

Products developed at advanced scale:

PRODUCT INDICATION API CERTIFICATION STATUS
Lanreotide
  • Long-term acromegaly treatment.
  • Local advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
 Scale-up to be planned (Cinisello) R&D completed
100 g scale
Icatibant
  • Symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children from 2 years old.
 Scale-up (Cinisello) Pilot level R&D API.
Market considered too small.
Linaclotide
  • Chronic idiopathic constipation.
  • IBS with constipation.
  • Opioid-induced constipation.
 - R&D development closed, to reopen. Chemical scale-up started.
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New chemical entities (NCEs) starting from clinical phases

Proprietary peptides

Available for CDMO-CMO activities

new- chemical entities

US-FDA, AIFA inspected facilities with JP accreditation:

  • Large scale capacity site in Patrica (Italy)
  • Small and medium scale capacity site in Cinisello (Italy)