Ravindar Rendla

Experience

• 

  Matrx laboratories limited

  Jul 2007 - Apr 2008

  Intern
• 

  Mylan Laboratories Limited

  Apr 2008 - Nov 2014

  • • Developed Para-IV projects.• Formulation Development, Optimization, QBD trials and preparation of Product Development Report and Quality Overall Summary.• Sending COA and samples for Bio equivalent studies.• Prototype formulation development, stability studies, release medium and MMDP profiles comparison against Innovator Product and formula finalization for scale up and Exhibit batches.• Developing solid oral dosage forms, Performing Preformulation studies, compatibility studies, prototype stability studies and Innovator's sample procurement and characterization of Oral solid dosage forms, Oral suspensions, Oral Solutions and ODT formulations.• Patent Assessment, Design and Development of Multiple Patent Non-Infringing formulations.• Preparation of Interim Product Development Reports and Status Reports.• Execution of Scale up, Exhibit, and Process validation batches.• Regulatory support until ANDA approval and preparation response to FDA queries.• Preparation of all technical documents like Product Development report, Master formula card, specifications, product development summary, and technology transfer dossier and protocols etc.• Finalization tablet tool drawings.• Provide technical support for trouble shooting of existing commercial products Developed stable dosage forms of CR formulations of new molecular entities using creative techniques.• Designed and performed the experiments, evaluated the scientific data.• Generated manufacturing procedure for clinical batches, technical reports, regulatory submission, and patent documents.• Established drug product specification for new products.• Supported the technical transfer team.• Assisted in establishing and monitoring stability programs for dosage forms and intermediates.• Drafted and revised "Investigational Clinical Production Direction (ICPD) documents for clinical manufacturing procedure in compliance with the company's established SOPs.• • Completed cGMP, GLP and safety training. Show less • Formulated an Extended Release tablets formulation indicated to reduce elevated TC, LDL-C, APO B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia and successfully completed the pilot studies, Scale up and Exhibit batches.• Formulated an Extended Release tablets formulation in combination with immediate release layer drug loading onto the ER core tablets and successfully completed the pilot studies, Scale up and Exhibit batches.• Developed a formulation for Oral Capsules for the treatment of active pulmonary and extrapulmonary tuberculosis (including renal disease) and successfully completed the pilot studies, Scale up and Exhibit batches.• Designed and performed the experiments.• Managed scale up, technical transfers and process optimization activities.• Generated the MBRs for stability, validation, commercial batches and SOP documents.• Conducted trouble shooting the manufacturing problems.• Evaluated new sources of API and excipients.• Led the investigation of the unsuccessful production batches to identify the root cause and drafted the investigation reports.• Formulated generic formulations and processes for the Antacid formulations using Drug layering Techniques for Delayed Release Capsules and Extended release Capsules using pellet Technology.• Preformulation studies, Compatibility studies and Innovator samples Characterization for Physical and Chemical evaluation and Literature search for Prototype formulation development. Show less

  • Formulation Development Assistant Manager

    Jan 2013 - Nov 2014

  • Formulation Development Executive

    Apr 2010 - Dec 2013

  • Formulation Development Officer

    Apr 2009 - Mar 2010

  • Formulation Development Trainee

    Apr 2008 - Mar 2009
• 

  Appco Pharma LLC

  Dec 2014 - Jun 2021

  • Formulation research and development of IR dosage forms, ER dosage forms, DR dosage forms, Oral solutions, suspensions, sachets.• • Formulation Development, Optimization, QBD trials and preparation of Product Development Report and Quality Overall Summary.• Sending COA and samples for Bio equivalent studies.• Patent Assessment, Design and Development of Multiple Patent Non-Infringing formulations.• Communicating with analytical department for analysis and Compilation of Analytical data.• Execution of Scale up, Exhibit, and Process validation batches.• Review of ANDA batches stability data and until approval and post approval.• Regulatory support until ANDA approval and preparation response to FDA queries.• Technology transfer, CBE-30, PAS and Alternate Source of API exploration and filing.• Scaling up of commercial batches, Validation batches for alternate equipment exploration and supporting documentation for FDA filing.• Review of R&D projects, Exhibit batches, Process validation batches and Commercial batches specifications, SOPs, Incidents, planned deviations, CGMP documentation, change controls, CAPA.• Preparation and review of all technical documents like Product Development report, Master formula card, specifications, product development summary, and technology transfer dossier and protocols etc.• Review of all technical documents like batch manufacturing documents and protocols, Process validation protocols, reports, Sampling protocols, reports, Cleaning validation protocols and reports.• Provide technical support for trouble shooting of existing commercial products.• Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Design Qualification (DQ).• • Execution of technology transfer related activities from development to launch for drug products (DPs) according to ICH, FDA and regulatory guidelines. Show less

  • Associate Director of Formulation Development & Technical Operations

    Nov 2018 - Jun 2021

  • Senior Manager Formulation Development & Technical Operations

    Dec 2014 - Oct 2018
• 

  Akorn, Inc

  Jun 2021 - Aug 2022

  Site Technical Services Leader commercial operations
• 

  I3 Pharmaceuticals, LLC

  Aug 2022 - Mar 2024

  Associate Director commercial operations
• 

  Aurobindo Pharma USA, Inc.

  May 2024 - now

  Manager