Contract Manufacturing & Research
Contract Manufacturing:
Daurala Organics started contract manufacturing in 2012. After conducting process development, we are currently commercially manufacturing 2 statin intermediates on a contract basis for a pharma Multinational.
Contract Research:
Contract Research was started in the year 2009. Worked on 5 key starting materials of various APIs.
Contract Manufacturing Strengths:
P & ID- GA Plan
- URS
- Qualifications (DQ, IQ ,OQ ,& PQ)
- Quality risk assessment (QRA)
- AIA,HIRA & HAZOP studies
- Cleaning validation
- Water Trials
- Validation Batches
- Proper documentation (i.e., Change control, deviation etc.)
- Developed and maintained manufacturing facility as per GMP
Contract Research Strengths:
- Fully equipped R&D Lab
- Dedicated R&D team for Contract Research
- Process development
- Process Validation
- Working standard preparation & qualification
- Analytical method development & validation
- Cost reduction
- Technology transfer report for further scale up.
- Mass balance
- Procedure for effluent treatment