About Hikma Thymoorgan

Hikma Thymoorgan was founded in 1980 and acquired by Hikma in 2007 with offices and factory in Vienenburg Germany, near the Harz Mountains. Thymoorgan is Good Manufacturing Practice certified and has manufacturing authorisation according to German Drug Law (§13 AMG).

Since 2010, the plant has also been approved by the US regulatory agency for export to the USA. The site specialises in manufacturing sterile, high potent drugs for parenteral use filled in glass vials, such as cytotoxic/cytostatic drugs for cancer treatments and antibiotics.

Our capabilities include:

  • Technology Transfer of products:

    • Analytical method transfers and verification

    • Microbiological method validation

    • Manufacturing of laboratory scale batches

    • Manufacturing of submission batches

    • Full process validation

  • Manufacturing of pilot batches for clinical trials

  • Laboratory scale batches for lyophilisation cycle verification and optimisation prior to manufacture

  • Stability chambers for Zone I, II, IVa and

    refrigerated products (25°C/60%RH, 30°C/65%RH, 40°C/75%RH, 2-8°C) allowing for stability studies for most countries

Our compliance record includes

  • US approval since 2010

  • Three US FDA audit inspections were successfully completed without any observation from form 483

  • EU approved

  • Regularly inspected by German Authorities (last in 2019)

  • GCC and Libyan approval in 2010

  • Several approvals by CIS countries

  • Brazil approval since 2011.

  • Russia approved in 2019

German Medical Information Enquiries, Complaints and Adverse Events Reporting

For further information or to report adverse events in Germany, please contact
portugaleupharmacovigilance@hikma.com