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Información sobre |
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BCN Peptides S.A. |
| Tipo de compañía: Productor químico a granel |
BCN Peptides is focussed entirely to the cGMP manufacture of Bioactive Peptides by Solid Phase Synthesis.
Our Key Technologies are:
• Solid Phase Synthesis.
• HPLC Purification.
• Lyophilisation under GMP conditions.
• Sterile Manufacture of Peptides
We concentrate our efforts in the following activities:
• Synthesis under cGMP of Bulk Generic Peptides.
• Custom Synthesis of proprietary API Peptides.
Our new facility allows us to be one of the leading companies into the GMP Industrial manufacture of bioactive peptides. We can manufacture multikilo batches of GMP Peptide using SPPS technology.
BCN Peptides Manufactures from the first R&D milligrams, through the pilot batches for the preclinical and Clinical Trials, up to the Bulk Quantities required for Commercialization.
We take care of Validating the manufacturing and analytical processes, synthesizing the related Impurities, performing the Stability Studies, writing the IMPD/IND and CTD/DMF, and any other quality or regulatory aspects that the FDA/USP or the EMEA/EP might require.
BCN Peptides works under High Quality Standards for strongly regulated markets. The company has been audited and approved by:
• FDA Approved
• EDQM Approved for the manufacture of Sterile Peptides.
• 6 CEP of the European Pharmacopoeia.
The products with CEP are: Salmon Calcitonin (sterile), Somatostatin, Leuprolide (sterile), Desmopressin, Buserelin and Goserelin.
BCN Peptides has been approved as Quality Control Pharmaceutical Laboratory by the Spanish Health Authorities, and is allowed to analyze and release Drug Product and also perform Stability Studies for Drug Product. This is a service which allow us to help our customers in their formulation work, with all the Quality Control related aspecs.
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| Dirección |
BCN Peptides S.A.
Poligon Industrial Els Vinyets-Els Fogars II
08777 Sant Quintí de Mediona
Barcelona, Spain
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| Telefono |
+34 93 819 13 99 |
| Fax |
+34 93 826 49 09 |
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Enviar email |
| Contactar a |
Dr. Jordi Piró |
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