At Medkem, we deliver APIs, Intermediates, formulations, and CDMO services across regulated and semi-regulated markets worldwide. With over 25 years of global experience, our expertise spans regulatory compliance, quality assurance, and supply chain reliability, enabling our partners to confidently access diverse healthcare markets.

1. Regulated Markets

We support countries with stringent regulatory frameworks, where compliance, documentation, and quality standards are paramount. Our offerings meet cGMP, USFDA, EU GMP, ICH, PMDA, and other global standards.

Key Countries & Notes:

  • United States (USA)
    • Compliant withUSFDA cGMP
    • SupportsDMF submissions, regulatory audits, and FDA-compliant packaging
  • European Union (EU)
    • Compliant withEU GMP & EMA guidelines
    • FacilitatesEU registration, CEP filings, and controlled export documentation
  • United Kingdom (UK)
    • Adheres toMHRA requirements & UK GMP standards
    • Supports regulatory dossiers and import authorizations
  • Canada
    • MeetsHealth Canada GMP & API/Drug Master File requirements
    • SupportsDrug Establishment Licenses (DEL) and regulatory submissions
  • Australia
    • Compliant withTGA GMP regulations
    • Supports market authorization and product registration
  • Japan
    • Compliant withPMDA and JP-GMP standards
    • Supports API/Formulation registration, import licenses, and technical dossiers
  • South Korea
    • Compliant withMFDS (KFDA) regulations & GMP standards
    • Supports market registration, documentation, and audit readiness

Our approach: Every regulated-market shipment is supported with full technical and regulatory documentation, batch records, Certificates of Analysis (CoA), and compliance-ready dossiers.

2. Semi-Regulated Markets

We serve markets with emerging or evolving regulatory frameworks, where reliable quality and consistent supply are crucial. Medkem ensures technical support, regulatory guidance, and product traceability for these regions.

Key Regions & Notes:

  • Africa
    • Support forlocal regulatory approvals and import licenses
    • Partnering with distributors to ensurecompliant supply chains
  • Middle East
    • Compliance withregional health authorities (e.g., SFDA, MOH approvals)
    • Facilitates market registration, documentation, and logistics
  • Latin America (LATAM)
    • Countries include Brazil, Mexico, Argentina, Chile, etc.
    • SupportsANVISA and local GMP documentation, import approvals, and logistics
  • Asia (excluding Japan & South Korea)
    • Focus on Southeast Asia, South Asia markets
    • Regulatory guidance forlocal market registrations and semi-regulated compliance

Our approach: Medkem provides education and support for distributors and partners to navigate regulatory complexities in semi-regulated markets.

 

3. Export Regions

Medkem ensures seamless global exports by combining regulatory, quality, and logistical expertise. Every shipment is auditable, traceable, and compliant for smooth customs clearance and timely delivery.

Services Offered for Export Regions:

  • Coordination withqualified logistics partners
  • Preparation ofexport-specific documentation (CoA, DMFs, MSDS, stability reports)
  • Regulatory compliance checksfor both regulated and semi-regulated countries
  • Temperature-controlled logistics where applicable forAPIs and formulations
  • Ongoing support forimporter and distributor regulatory requirements

Our mission: Deliver reliable, compliant, and timely pharmaceutical exports to all markets, ensuring uninterrupted supply to global partners.