Process Development and Scale up
- Process development and scale up services to both Innovators and Generics customers.
- Process optimisation of existing processes.
- Process development for existing intermediates for which source is not available, or where
second source is required. - Process development, with non-infringing route.
- Process scale-up and technology transfer as per specified guidelines.
- Analytical method development and validation.
- Impurity characterisation.
- Support for regulatory documentation & filing at various regulatory agencies.
Contract Manufacturing
- From our GMP compliant leased facilities, we offer third party manufacturing as well as contract manufacturing services to our customers.
- We have a well-qualified team to decode and adopt the technology transfer documents received from our customer.
- Our well-qualified production team will then initiate, the lab trials, adopt the process, scale-it up and deliver the commercial batches at stipulated timelines.
- We can take the contract manufacturing for our customers, who will give the exact “know how”, suppliers, process etc.
- We can also take up third party manufacturing, where in the process will be ours, we will develop competitive suppliers for various inputs.
Formulation Development
- Formulation development for the APIs which we have developed for our customer.
- Technical Document Preparation.
- Selection and finalisation of vendors for all the Raw Materials and Packing materials.
- Non-GMP/ GMP batches of the formulations.
- Analytical Method / Validation for the process developed by us.
- Impurity Characterisation.
- Support for regulatory documentation & filing at various regulatory agencies.
Niche Services
➤ Herbal formulations
➤ Neutraceutical formulations