Sterile Manufacturing, Sacramento
Nivagen has a c-GMP sterile injectables facility spanning 100,000 sq ft in Sacramento, CA, USA with the aim of expanding CDMO services and 503B products to address FDA shortages.
Nivagen has a c-GMP sterile injectables facility spanning 100,000 sq ft in Sacramento, CA, USA with the aim of expanding CDMO services and 503B products to address FDA shortages.
Venkatesh Brings over 26 years of experience as a seasoned expert in strategic planning, design, construction, and facilities operations across healthcare, pharmaceutical, and FMCG industries. He has held senior management roles in engineering and construction for major pharmaceutical manufacturers, including Teva (formerly Watson), Cipla Ltd, Piramal Pharma, Dr. Reddy’s, and Mondelez (formerly Cadbury).
Mechanical Engineer with extensive experience in sterile facility design, Venkatesh is renowned for his expertise in state-of-the-art sterile isolator technology. His extensive work spans the design, build, and operation of sterile facilities across the USA, UK, and India. Venkatesh’s earlier experience evolved around building the facility for aseptic, oral solid dosage (OSD), ointment, soft gel capsule, and high-potent sterile and OSD manufacturing facilities with a major Focus on operational efficiency, cost-effectiveness, innovation, and long-term sustainability in project execution.
A seasoned pharmaceutical executive with over two decades of pharmaceutical and healthcare industry experience, Dr Patel brings a wealth of expertise to Nivagen. With an unwavering focus on scientific excellence and strategic innovation, he drives the development of groundbreaking solutions. Dr. Patel’s expertise in process development, regulatory strategy, and team building is instrumental in translating complex scientific concepts into tangible, market-ready products.
Prior to joining Nivagen, Dr Nirav held key roles at leading pharmaceutical companies including Amneal, Ingenus, Jubilant, Baxter, Symbiotec and Dorizoe. His impressive track record includes the successful launch of multiple complex branded (505(b)2) and generic (ANDA) injectables and ophthalmic formulations, demonstrating a deep understanding of the regulatory landscape and patient needs. As a visionary leader, Dr. Patel fosters a culture of innovation, inspiring his team to achieve unprecedented heights in drug development.
Holding advanced doctorate degrees in pharmaceutical science, Dr Patel is a strategic thinker with a strong scientific focus. He has authored numerous journal articles and holds several patents in formulation development. His strategic acumen, coupled with a strong operational focus, positions Nivagen at the forefront of pharmaceutical advancements.