“SHAILESHBHAI KAKLOTAR is a Lead Scientist in Analytical R&D at Amneal Pharmaceuticals LLC, with over 14 years of experience in pharmaceutical research and development. My work focuses on analytical method development, validation, and regulatory-driven data interpretation, supporting both ANDA and 505(b)(2) NDA submissions. He has extensive experience with diverse and complex dosage forms, including nasal sprays, oral solutions, transdermal patches, suspensions, injectables, semisolids, and solid oral products.
In his current role, lead projects in Analytical R&D, concentrating on reverse engineering of reference formulations, impurity profiling (including nitrosamine risk assessments), solid-state characterization, dissolution, and in-vitro drug-release profiling. He is highly proficient in advanced analytical instrumentation, including HPLC, UPLC, GC, GC-MS, LC-HRMS, XRD, DSC, UV spectroscopy, rheology, and particle-size characterization.
He holds a Master’s degree in Pharmaceutical Manufacturing Engineering from Stevens Institute of Technology (NJ) and a Bachelor of Pharmacy from Maliba Pharmacy College (India). Beyond his industry contributions, he is actively serve as a peer reviewer for scientific journals, helping to ensure the quality, credibility, and integrity of published research.