Socosur

About Socosur

Socosur Chem. is a French consulting company and its core business is importation and distribution of Active Substances with successful track record of ANSM GDP inspections.

Our 3 activities are
-        Importation and Distribution focused on Active Pharmaceutical Ingredients, especially in Antibiotics, Cardiology, Ophthalmic and Oncology therapeutics.
-        Solution provider for Biotech companies looking to industrialize their Active Pharmaceutical Ingredients.
-        Toxicology risk assessment reports, for human and veterinary medicines, signed by Eurotox experts: PDE, OEL, organic, elemental impurities and extractible _ leachable impurities, Environmental Risk Analysis …

Certifications
  • FR
  • 2015
    On CPhI since
  • 1
    Certificates
  • 1 - 24
    Employees
Consultancy
Distributor/Import Export
Contact info

Products from Socosur

  • Brinzolamide

    Product Brinzolamide

    Socosur offers wide range of api's which includes brinzolamideCategory: Ophtalmology
    Therapeutic class: Carbonic anhydrase inhibitors


    Contact us for more information
  • Ciclosporine A

    Product Ciclosporine A

    Socosur offers wide range of api's which includes ciclosporine a. Category: ophtalmology. Therapeutic class: immunosupressant. Contact us for more information.
  • Epinastine Hydrochloride

    Product Epinastine Hydrochloride

    Socosur offers wide range of api's which includes epinastine hydrochloride. Category: ophtalmologyTherapeutic class: antihistamine decongestant


    Contact us for more information.
  • Erythromycin Base

    Product Erythromycin Base

    Socosur offers wide range of api's which includes erythromycin baseCategory: dermatology
    Therapeutic class: antibiotic
    Contact us for more information.
  • Erythromycin Stearate

    Product Erythromycin Stearate

    Socosur offers wide range of api's which includes erythromycin stearate. Category: antiinfectives. Therapeutic class: antibiotic. Contact us for more information.
  • Erythromycin Thiocyanate

    Product Erythromycin Thiocyanate

    Socosur offers wide range of api's which includes erythromycin thiocyanate. Category: veterinary use. Therapeutic class: antibiotic. Contact us for more information.
  • Fenofibrate

    Product Fenofibrate

    Socosur offers wide range of api's which includes fenofibrate. Category: cardiovascular sytem. Therapeutic class: treatment hypercholesterolaemia and hypertriglyceridaemia. Contact us for more information.
  • Fluorescein Sodium

    Product Fluorescein Sodium

    Socosur offers wide range of api's which includes fluorescein sodium. Category: ophtalmology. Therapeutic class: diagnosis. Contact us for more information.
  • Isosorbide Dinitrate

    Product Isosorbide Dinitrate

    Socosur offers wide range of api's which includes isosorbide dinitrate. Category: cardiovascular sytem. Therapeutic class: coronary vasodilator. Contact us for more information.
  • Isosorbide Mononitrate

    Product Isosorbide Mononitrate

    Socosur offers wide range of api's which includes isosorbide mononitrate. Category: cardiovascular sytem. Therapeutic class: cardiology antianginal. Contact us for more information.
  • Rifamycin Sodium

    Product Rifamycin Sodium

    Socosur offers wide range of api's which includes rifamycin sodium. Category: antiinfectives. Therapeutic class: antibiotics. Contact us for more information.
  • Vancomycin Hydrochloride

    Product Vancomycin Hydrochloride

    Socosur offers wide range of api's which includes vancomycin hydrochloride. Category: antiinfectives. Therapeutic class: antibiotics. Contact us for more information.

Socosur Resources

  • Whitepaper Implications of calculating the PDE as the exposure limit for the analysis of risks in shared installations

    In November 2014, the European Medicines Agency (EMA) published the Directive EMA/CHMP/ CVMP/SWP/169430/2012 on the establishment of exposure limits based on health criteria during the manufacture of different drugs in shared installations.In January 2015, the European Commission also revised Chapters 3 and 5 of the EU GMP Guidelines, updating the sections on the prevention of cross-contamination.
    These updates entered into force in March of the same year.
    Further, Annex 15 of the EU GMP Guidelines (item 10.6) stipulates that "The residual contamination limits of the product must be based on a toxicological assessment".
    The dates for implementation of the new EMA Guidelines were June 2015 for new products and December 2015 for existing products (with deferral of these deadlines for a year for veterinary products).
    Up until then, the limit values of 10 ppm or1/1000 of the lowest clinical dose were used for cleaning validations. The use of conventional limits translated, on the one hand into excessively restrictive limits for low toxicity products, far exceeding the limits necessary to guarantee patient safety. And on the other hand, the conventional limits did not offer enough protection for products considered to be highly toxic. Up until then, the categories with the highest risks concerned “certain hormones", "certain cytotoxic agents", etc., with no specific criteria.
    Release of the EMA Directive implies determining exposure limits in accordance with toxicological criteria, and on the basis of characteristics inherent to each substance.The PDE (Permitted Daily Exposure) is calculated from pharmacological, toxicological and pharmacokinetic data and is similar to the ADE value (Acceptable Daily Exposure) described in the IPSE (International Society for Pharmaceutical Engineering) RiskMaPP.The two values represent the maximum daily dose of a substance that is not likely to cause adverse effects in an individual who is exposed to this dose or to a lower dose, every day throughout their life. In order to facilitate the implementation of these new GMP regulations in the pharmaceutical industry, the Socosur team of toxicology experts launched a project to calculate PDE values for Active Pharmaceutical Ingredients ("API"), as external service provider in January 2015.With an experience that is unique in Europe as a result of having performed the toxicological assessment and preparation of 1200 PDE monographs, we conducted an in-depth meta-analysis of the data obtained.A classification of PDE values was established, identifying 5 groups and allocating a danger level to each of them.
    The results were analyzed against the ATC classification (anatomical, therapeutic, chemical) therapeutic groups.