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PEPTIDES COMPANION

Space Peptides / a SPACE PHARMACEUTICALS company

GMP peptide manufacturing

Generic Active Pharmaceutical Ingredients (APIs) Product Line

Our generic API product line focuses on women’s health, diabetes and osteoporosis.

 

Peptide nameMode of action and clinical use
Atosibanan inhibitor of the hormones oxytocin and vasopressin used as an intravenous medication as a labour repressant to halt preterm labor (Gynecology, Obstretrics).
Cetrorelixan injectable gonadotropin-releasing hormone (GnRH) antagonist used in assisted reproduction (Gynecology).
Bivalirudina thrombin inhibitor. It inhibits both circulating and clot-bound thrombin, while also inhibiting thrombin-mediated platelet activation and aggregation (Cardiovascular).
Liraglutideused to treat diabetes mellitus type 2 and obesity (Endocrinology).
Semaglutideused for the treatment of diabetes mellitus type 2 (Endocrinology).
Teriparatidea form of parathyroid hormone consisting in the bioactive portion of the hormone. It is an effective anabolic (promoting bone formation) agent used in the treatment of osteoporosis (Endocrinology, Musculoskeletal).
Elcatonina caltonin derivative used as an anti-parathyroid agent for remitting or eliminating pain caused by osteoporosis (Endocrinology, Musculoskeletal).

New Chemical Entities (NCE)

For the most stringent requirements, we have delivered peptides with > 99.5% purity and less than 0.1% of any single impurity.

The typical components are:

  • Process development, optimization and validation
  • Scale-up
  • Process control and impurity studies
  • Comprehensive analytical studies
  • Three batches for process validation
  • Stability studies and documentation preparation
  • Drug Master Files (DMF) and market registration / Regulatory affairs

Figures: Space Peptides is expanding with a large-scale manufacturing site in Jiangsu, China, with a total capacity of 1100kg/year (in progress).