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Nikhil Girase

Nikhil Girase

Product Development (Oral-solids and Injectables) for the US market

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location of Nikhil GiraseNavi Mumbai, Maharashtra, India

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  • Timeline

  • About me

    Formulation Development || University Gold Medalist ||GPAT Qualified||

  • Education

    • R. C. PATEL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH, SHIRPUR

      2021 - 2023
      Master's degree A+ With University Gold Medal🏅

    • SES'S R.C.PATEL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH, SHIRPUR, DIST DHULE

      2016 - 2020
      Bachelor of Pharmacy Pharmacy

  • Experience

    • Endo Pharmaceuticals

      Sept 2022 - now
      Product Development (Oral-solids and Injectables) for the US market

      Performed literature survey and patent landscape for new product development.To develop injectable formulations like pre-filled syringes, Lyophilized Injection.To develop IR, ER tablets by using High shear mixing granulation (HSMG) process and Wurster coating technology.To review, evaluate, interpret, and report experimental results to ensure the objectives of the project (pre-formulation study, Dissolution study, stability studies, and routine analysis)Based on results, execution of trials for prototype development.Preparation of Product development report.Preparation of documents (BMR)/ stage gate presentation for engineering, and submission batches to execute at the cGMP facility.Co-ordinate with cross-functional teams for the timely completion of assigned activities.To ensure that all work is performed in compliance with the required applicable SOPs, cGMP, GLP.To execute exhibit batches at Par Formulation, Chennai. Show less

  • Licenses & Certifications