At Winthrox, our new product development program generally includes pre-formulation studies, excipient compatibility studies, analytical methods development and validation, formulation development and optimization, formal stability studies, and manufacturing process development according to ICH Guidelines. At Winthrox, we also have a quality program dedicated to continuous improvement of product quality of running products at a dedicated high-tech R&D site.
These laboratory-scale batches are subjected to stability as per the ICH norms. The complete documentation of the laboratory data is presented in a format compliant with international standards . Through a combination of state-of-the art analytical instrumentation, infrastructure meeting global development standards, and world-class expertise and level of scientific excellence, we ensure that our clients receive true added value to their R&D projects, completed in the speediest and most cost-effective manner without compromising data quality.
At Winthrox, we understand that a sound infrastructure meeting global standards is an essential part of achieving our deliverables. Our laboratories are well-equipped to handle:
- Tablets, immediate release
- Tablets, controlled or sustained-release including MUPs
- Tablets, enteric coated
- Capsules, filled with powder, granules, mini tablets or pellets
- Capsules, controlled or sustained-release
- Oral liquids and suspensions
- Ocular drops
- Sachets
- Injectable dosage forms including lyophilized products