- 45 Davids Dr. Hauppauge, New York 11788, USA
- Call (631) 231-2751
- Email info@saptalis.com
Polireddy Dondeti, Ph.D. is a co-founder of Saptalis Pharmaceuticals and currently serves as President and CEO. Dr. Dondeti is also Chairman of the Board of Directors of the Company.
Dr. Dondeti is a proven product development leader with thorough knowledge of pharmaceutical sciences and regulatory environment. He is responsible for bringing numerous complex prescription dosage forms to the market. Dr. Dondeti has over 27 years of industry experience with various pharmaceutical companies such as Barr Laboratories and Morton Grove Pharmaceuticals. Prior to co-founding Saptalis, he was Vice President, R&D at Hi-Tech Pharmacal Co., a company specialized in sterile and non-sterile liquid and semi-solid dosage forms.
Dr. Dondeti received his M.S. in Pharmaceutics and Ph.D. in Pharmaceutical Sciences from the University of Rhode Island.
Tatiana Akimova, Ph.D. is a co-founder of Saptalis Pharmaceuticals and currently serves as Executive Vice President, Corporate Development. She is a Member of the Board of Directors.
Dr. Akimova brings to the Company over 20 years of experience in corporate development, licensing and acquisition of products, forging strategic alliances with industry partners. Prior to co-founding Saptalis, she was Vice President of Strategic Planning at Hi-Tech Pharmacal, Co.
Dr. Akimova received her Ph.D. from St. Petersburg University in Russia and MBA from Stony Brook University.
Nirav Shah is responsible for designing, constructing and maintaining Saptalis manufacturing facilities to meet GMP requirements.
Mr. Shah has over 25 years of experience in pharmaceutical operations with design, installation, and maintenance of pharmaceutical processing equipment. His expertise in plant management, logistics and project management and extensive knowledge of cGMP environment is based on experience at various companies including Amneal Pharmaceuticals and Invagen Pharmaceuticals. Prior to joining Saptalis, Nirav was Vice President of Engineering at Ascent Pharmaceuticals.
Mr. Shah holds a Bachelor's degree in Mechanical Engineering and an Executive MBA degree in Pharmaceutical Management.
Mr. Yeruva has over 19 years of experience in the pharmaceutical industry. As the Vice President of Operations and IT, he oversees all operational and IT activities at Saptalis.
Before joining Saptalis, he worked for Aurolife Pharma LLC as Senior Scientist for one of the manufacturing facilities in their pharma network. At Dr. Reddy’s Laboratories Ltd and Aurigene Discovery Technologies Ltd., he was a part of the executive leadership team, where he played an integral role in optimizing the DMPK portfolio/pipeline strategy and supporting the NCEs and responsibilities in general management. Mr. Yeruva comes to Saptalis with diverse skills and experiences, including operations, installation and maintenance of analytical laboratory instruments, computer systems with data acquisition and regulatory software and production systems, including serialization capabilities.
Mr. Yeruva holds a Master’s degree in Pharmaceutical Analysis and a Bachelor’s degree in Pharmacy from Rajiv Gandhi University of Health Sciences, Bangalore.
Mr. Naringrekar is responsible for leading and coordinating activities of Product Development and Technical Operations teams at Saptalis.
Mr. Naringrekar is an experienced formulation scientist with expertise in technology transfer, process optimization, validation activities and commercial launches. He has 19 years of industry experience and played a critical role in successful approvals of multiple niche and complex generic products, such as ophthalmic suspensions, sterile gels, nasal sprays, oral suspensions and topical creams and ointments. During his career, Mr. Naringrekar has worked in specialty companies including Trigen Laboratories and Hi-Tech Pharmacal Co. Prior to joining Saptalis, Mr. Naringrekar was Manager, R&D Formulations at Aurobindo Pharma USA Inc.
Mr. Naringrekar holds an M.S. degree in Pharmaceutical Sciences from Northeastern University and a Bachelor's degree in Pharmacy from Bombay College of Pharmacy.
Ms. Kallam provides Quality and Regulatory compliance oversight at Saptalis to assure that all manufacturing, testing and product development activities are conducted as per USFDA regulations. She establishes compliance procedures and develops strategies to ensure the Company complies with all federal, state, and local regulations, including cGMP, cGLP, USP, ICH and USFDA guidelines.
Ms. Kallam provides CMC strategic guidance for submission of ANDA/NDA filings to the FDA to assure their high quality and timely approval. Proficient with use of software tools such as eCTD and SPL Editor for submission of regulatory filings to the USFDA.
Ms. Kallam holds a B.Pharm. degree from Jawaharlal Nehru Technological University, Hyderabad, and M.Pharm. degree in Pharmaceutical Technology from Andhra University, Vishakhapatnam, India.
Mr. Borden is responsible for Quality oversight of all activities associated with pharmaceutical product manufacturing as per cGMP regulations and FDA guidelines.
Robert is a highly experienced quality specialist with expertise in cGMP compliance in the pharmaceutical manufacturing environment. He has over 20 years of experience in implementing quality systems throughout the organization, leading and training the operations teams to assure the highest quality of manufactured products. During his career, Mr. Borden has worked in companies specializing in manufacturing prescription and OTC drug products, including Forest Labs, Inc and Contract Pharmacal Corp. Prior to joining Saptalis, Mr. Borden was Specialist, Manufacturing Quality at Kedrion Biopharma, Inc.
Mr. Borden holds a B.S. degree in Biochemistry from Stony Brook University, NY.
Mr. Azeez is responsible for all major aspects of Saptalis Sales& Marketing operations, including budgeting, forecasting, pricing analysis, 3PL relationship management, GTN calculation, revenue recognition, monthly and quarterly report calculation.
Over his nearly 30-year career, Mr. Azeez has held high level positions at financial institutions and pharmaceutical companies, most recently (2009-2023) at Strides Pharma, Inc and Micro Labs USA, Inc. During his tenure, he has been relied upon to develop business strategy and ensure operational excellence.
Mr. Azeez holds a BS degree in Finance from Rutgers University and MBA degree from Boston University.