Synbias Pharma AG offers a robust selection of oncology-focused APIs with global regulatory documentation, including US DMFs, CEPs, and other key filings. Our portfolio includes anthracyclines and nucleoside analogs designed to meet the highest quality standards.
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.
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, 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.
Through a significantly optimized synthetic pathway, Gemini PharmChem has re-engineered the production of Valrubicin to proactively exclude the formation of typical process-related impurities. By integrating a sophisticated, multi-stage high-efficiency chromatographic purification protocol - applied to both the key intermediate and the final API - we ensure exceptional process robustness and product purity. This advanced technological approach not only streamlines production but guarantees a superior quality profile that meets the most stringent pharmaceutical standards.
The production of Pirarubicin at Gemini PharmChem achieves a market-leading purity profile by leveraging a strategically shortened synthetic route compared to standard manufacturing processes. A key advantage of our method is the use of our own high-purity Doxorubicin API as the starting material, which minimizes the introduction of impurities from the very outset. The process is further enhanced by a multi-stage purification protocol, incorporating high-efficiency chromatographic stages followed by a cascade of crystallization steps to yield a final API of unmatched chemical purity.
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.
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