SynbiasPharma/Gemini
Commercially available products and registration

Doxorubicin HCI

  • CEP is available
  • US-DMF is available
  • CADIFA is available
  • C-DMF is available
  • J-MF is available
  • K-DMF is available
  • Registered in India

Epirubicin HCI

  • CEP is available
  • US-DMF is available
  • C-DMF - registration is in progress
  • J-MF is available
  • Registered in India

Idarubicin HCI

  • ASMF is available (registered in 20 EU countries)
  • US-DMF is available
  • C-DMF - registration is in progress
  • K-DMF is available

Nelarabine

  • US-DMF is available

Valrubicin

  • US-DMF is available

Excellence in API Manufacturing: Superior Purity, Stability, and Efficiency

Epirubicin: A Benchmark of Purity and Stability

Epirubicin produced by Gemini PharmChem sets a new standard in the Epirubicin API market, featuring a crystalline, non-hygroscopic form that offers superior solubility and thermal stability. The product remains stable for at least 48 months at 25°C, eliminating the need for special storage or transportation conditions, which are required for the more common amorphous form of Epirubicin. Gemini PharmChem’s Epirubicin stands out due to its significantly stricter impurity specifications. The product limits impurities (excluding Doxorubicin and Doxorubicinone) to 0.10%, which is much lower than the 0.5% limit set by the European Pharmacopoeia. These enhancements make Epirubicin, produced by Gemini PharmChem, a superior choice for pharmaceutical manufacturers seeking high-quality APIs with long shelf lives and minimal transportation challenges.

Doxorubicin: Purity Through Process Efficiency

An innovative approach to Doxorubicin synthesis results in a shorter and more efficient production process than that of its competitors, yielding a product with unmatched purity. By reducing the number of synthetic steps, Gemini PharmChem minimizes the formation of unwanted by-products and impurities. The company’s Doxorubicin specification limits any impurity (except Doxorubicinone) to 0.10%, far surpassing the European Pharmacopoeia’s limit of 0.5%, ensuring that the final product is both effective and safe for use in cancer therapies.

Idarubicin: Streamlined Synthesis for Enhanced Purity

Idarubicin, another critical product in Synbias-Gemini’s portfolio, benefits from a unique synthesis route that includes fewer stages than that of competing manufacturers and excludes the formation of side isomers of idarubicin. This streamlined process allows for the production of Idarubicin with a typical purity of at least 99.9%, setting it apart as the highest-purity Idarubicin available on the market. The reduced synthetic complexity also means that fewer impurities are introduced during manufacturing, further enhancing the safety and efficacy of the API.

Nelarabine: Stereospecific Synthesis for Precision and Stability

The production of Nelarabine at Gemini PharmChem is distinguished by the use of a stereospecific enzyme-catalyzed synthesis, which allows for precise control and reduces the formation of impurities. The API achieves remarkable purity, with individual impurity limits set at no more than 0.05% and total impurities not exceeding 0.50%. Furthermore, Nelarabine exhibits excellent thermal stability, maintaining its integrity for at least 36 months at 25°C without requiring special storage or transportation conditions. These attributes make it a reliable and efficient choice for pharmaceutical companies focused on long-term stability.

SynbiasPharma/Gemini
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