Dasha Pharmaceuticals

Generic API & Intermediates

Dasha Pharmaceuticals extend the process development support for late phase molecule. The development methodology include, familiarization, process optimization plan and identification of unit operation for further development, stress studies, CMA, CPP, CQA, impurity   identification, structure elucidation, impurity purging methodology, crystallization, salt screening, polymorphic evaluation, Re-process strategy as preventive plan and Re-work plan for correction, FMEA, QBD, cleaning procedure, Demonstration batches followed by Engineering batches before validation.

In addition, method development for IPC, intermediates, raw material analysis, impurity evaluation, stability studies, residual solvent, release analysis, defining the specifications for intermediates and API’s, also all other analytical techniques that fulfil the quality of  API like metal content, PGI. Also will provide the support in documentation for filing.

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