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    Support throughout all phases of development

    The softgel service provider of choice for the pharmaceutical, over-the-counter and health & wellness industries.

    Certification and Compliances

    Licenses & Certifications

    Capcium is committed to producing high-quality products that meet FDA, Health Canada, and EMEA cGMP standards. We possess a Drug Establishment License (DEL),  Site License from Health Canada’s Natural Health Products Directorate (NHPD), Cannabis Act site license, NSF certification.

    Certifications & Compliances

    GMP Manufacturing Good Practice
    Santé Canada - Health Canada
    US FDA
    European Medicines Agency

    Category / Segment

    Drug Establishment License

    All Canadian drug establishments must hold, since January 1, 1998, an establishment license to fabricate, package, label, distribute, import, wholesale, or test a drug. A necessary license in order to manufacture and distribute drug product issued after a satisfactory cGMP inspection.

    Health Canada Natural Products

    The Program assesses all NHPs before allowing their sale in Canada. It also verifies that NHPs are properly manufactured (without contamination or incorrect ingredients). The Program monitors companies involved in NHPs to make sure they respect the Natural Health Products Regulations.

    NSF Certification

    NSF certification services assure suppliers, retailers, regulators and consumers that an independent organization has reviewed a product or system to comply with specific standards for safety and quality. Ensuring that companies comply and be accountable to meet safety standards.

    Cannabis License

    A federal license is required to cultivate, process and sell cannabis for medical or non-medical purposes. All federal license holders can conduct related activities such as possession, transportation, storage, destruction, research and development, and sale of bulk cannabis to other federal license holders.

    Solutions for all fields of health

    Capcium manufactures with industry leading safety and quality standards, we provide regulatory support for the marketed territories and for the market segment applications.

    Capcium - Pharmaceutical Solutions

    Pharmaceuticals

    Capcium leverages ways to increase efficiency to accelerate time to market through a more collaborative, customer-focused drug life cycle. Our precision-focused, pharmaceutical-grade cGMP manufacturing operation’s agility supports the specific needs of our pharmaceutical customers.

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    Capcium - Over-the-Counter Solutions

    Over the Counter (OTC)

    Capcium is dedicated to developing and manufacturing name brand and non-prescription drug products in the most cost effective solutions to support the growing market demand, from pain relievers analgesics, to cough and cold medication.

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    Capcium - Nutritional Solutions

    Nutritional

    Capcium’s ability to handle oils, complex pastes and size diversity formulations with no leakages, ensures that your final dose product will be compliant with all the regulations, meeting its label claim and achieve its optimal ingredient delivery.

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    Let’s discuss your project

    Softgels, what we do best, our focus, our experience, your contract manufacture service provider of choice.

    Our Services