As Candidate

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    cGMP Kilo Scale Synthesis Chemistry

    We have a well-established kilo laboratory for the synthesis of compounds in multi grams to kilograms level. During kilo synthesis we always look for the cost effectiveness.

    • Develop and optimize safe, eco-friendly and cost effective processes.
    • Manufacturing of all clinical trials material under cGMP conditions.
    • Support all IND enabling activities as per the international guidelines.
    • Assist in reducing IND and NDA filing timelines and escalating the launch of the drug in the market.

    Key Features

    • Access to international quality analytical labs and facilities at the same location.
    • Equipped with 20L to 200L capacity reactors to handle a wide range of reactions under -80 to +200 degree C temperature range.
    • Thorough understanding of the chemistry involved for seamless technology transfer from R&D laboratory to kilo scale synthesis.
    • Hazop studies prior to carrying out any unknown reaction and other HSE measures.
    • Project management expertise enabling troubleshooting and problem solving on real time basis.
    • Efficiency, time optimization, innovative analytical approach with highest QC standards.
    • Independent and separate QA function to ensure rigid adherence to International guidelines and laid down SOPs.
    • Experienced production and QA professionals.