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cGMP Kilo Scale Synthesis
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.
- 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.