Pharmaceuticals - , Maharashtra, India
We are a privately held research driven pharmaceutical company focussed on pharmaceutical drug product development and technology transfer to manufacturing site across the globe. We aim to provide challenging solutions to generic as well as brand companies to develop and establish new technology platforms and seamless transfer of existing technologies. Also, engaged in the development of Generic and Non- Infringing product technology including conducting studies necessary for a comprehensive dossier preparation of ANDA/EMEA submission.The research activities are conducted in a state of the art modern R&D facility set up with a vast scientific knowledge pool confirming to international standards. We are a state of art pharmaceutical research and development facility spread over 3000 sq. built as per international standards. We have adequate eequipment and instruments to carryout research and development activities with highest quality standards.Pre-Formulation studies: API Characterization, API forced degradation (As per ICH and FDA requirement), Solubility profiling in buffers and non-aqueous solvents, Excipients compatibility testing, Solid-state and solution-state stability and photo-stability, LOD/LOQ, Physical characterization. We are certainly in a position to cater to you outsourced needs of the product development especially Proof of concept, lab batch development, stability and analytical development and validation. We also provide you with totally non-infringing methods and also scalable formula and process with batch record as per your requirement. We are indeed in a position to conduct effective and sustainable technology transfer at your customer shop floor.
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