Licensing & manufacturing

SOPHARMA AD is a holder of Manufacturing Authorization with the following manufacturing sites:


Scope of authorisation

Human Medicinal Products

  • Sterile products:
    • Aseptically prepared;
    • Terminally Sterilized.

  • Non-sterile products:
    • Capsules;
    • Hard shell;
    • Suppositories;
    • Tablets;
    • Liquids for external use;
    • Liquids for internal use: syrups, oral suspensions, oral solutions;
    • Semi-solids: creams, gels, ointment.

Human Investigational Medicinal Products
SOPHARMA AD has Registration as Manufacturer, Importer and Distributor of Active Substances which are used as main ingredients in the manufacturing of medicinal products for human use.

Address(es) of site(s) where registered activities take place:

110, 23rd Pehoten Shipchenski Polk Blvd., Kazanlak 6100, Bulgaria
16 Iliensko Shosse Str., Sofia 1220, Bulgaria

All manufacturing activities are GMP compliant and are included in the GMP Certificates issued by the Competent Authorities.