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MANAGEMENT

GAVIS® has a Trusted Team of experienced professionals with
300+ years of generic pharmaceutical experience.

 

 

Veerappan Subramanian, Ph.D.
Chairman and CEO
Dr. Veerappan Subramanian has over 30 years of experience in the pharmaceutical industry and has developed and commercialized more than 200 specialty drug products. Prior to founding GAVIS, Veerappan founded Kali Laboratories, Inc. in 1997. He grew Kali from a developmental company to a full-service pharmaceutical company, which he sold to Par Pharmaceutical, Inc. in 2004. Veerappan continued to serve as Executive Vice President of Par until 2006, helping to transition Kali Labs into Par. Prior to founding Kali Labs, Veerappan was Vice President of Scientific Affairs at IVAX/Zenith Laboratories from 1990 until 1996. He joined Zenith as part of the executive team responsible for revitalizing and developing the company, which was ultimately sold to IVAX in 1994 for over $600 million. From 1984 to 1990, Veerappan was Director of Product Development and Technical Services at Purepac Pharmaceuticals where he developed and commercialized over 50 specialty pharmaceutical drug products. Veerappan worked at Johnson & Johnson as a Senior Scientist from 1978 to 1980 and as a Senior Scientist for Richard Vicks from 1981 to 1984. From 1973 to 1975, Veerappan worked in India for a division of Squibb.Veerappan has both a Bachelors and a Masters degree in Pharmacy. In 1981, he received his Ph.D. in Pharmacy from Rutgers University in New Jersey. He is a registered pharmacist in New York and New Jersey.
Tammy McIntire Stefanovic
President
Tammy McIntire Stefanovic, a long-time pharmaceutical executive, joined GAVIS Pharmaceuticals as President of its U.S. operations in early 2012. She was previously president of Apotex Corporation based in Weston, Florida. She brings extensive experience to the GAVIS team in negotiating and developing marketing strategies to build relationships with key pharmaceutical customer segments, pricing strategy development, business development, revenue growth and acquisition integration capabilities. Stefanovic, a registered pharmacist, worked at Cardinal Health from 1991to 1998. As vice president of pharmaceutical services for Cardinal Health Inc., a 10.5 billion dollar national drug wholesaler based in Columbus, Ohio, her focus was on formulary management and maximizing supplier revenues. Promoted to director of pharmaceutical services in 1993, she spearheaded initiatives ranging from rapid distribution programs for new products to managing incentives and sales plans for a field sales force of 150. Her demonstrated leadership abilities led to her appointment as vice president of pharmaceutical services in 1995 where she assumed responsibility for generic pharmaceutical and generating revenues in excess of $850 million. Stefanovic holds a bachelor’s degree in pharmacy from Ohio Northern University and a master’s of pharmaceutical administration from Ohio State University.
Kevin Anderson
Vice President, Sales and Marketing
Kevin Anderson joined GAVIS Pharmaceuticals at its inception in July 2008 as Vice President of Sales and Marketing. With over to 30 years of experience in Sales and Marketing in the pharmaceutical industry, Kevin is adept at building relationships and providing customers with the highest level of service. Prior to joining GAVIS, Kevin held senior management positions with Actavis, a dynamic worldwide generic company, and with Amide Pharmaceutical a U.S. generic pharmaceutical manufacturer. At Actavis he led the commercial integration of the U.S. acquired companies Amide Pharmaceutical, Alpharma/Purepac, and Abrika. Prior to the Actavis acquisition, his role at Amide was Vice President of Sales & Marketing where he increased profitable sales in excess of $125 million. Kevin has developed strategic and lasting relationships with key customer executives in the following trade organizations: Chain Drug (NACDS), Mail Order Pharmacy (PCMA) and Wholesaler/Distributor (HDMA).
Scott Talbot
Vice President, Quality Assurance and Regulatory Compliance
Scott joined GAVIS Pharmaceuticals in November 2010 as Director of Quality Assurance & Regulatory Compliance and during his tenure, demonstrated leadership abilities which led to his promotion to Vice-president of Quality Assurance and Regulatory Affairs in Jan 2012. In this role, Scott oversees all quality operations for the Wintac and Somerset facilities and approves all communications with the FDA and other regulatory agencies. Scott is a seasoned Quality Assurance and Regulatory Affairs professional with over 25 years’ experience in pharmaceutical manufacturing and development. He has worked for several large pharmaceutical firms with increasing levels of responsibility and took the leadership role in presenting to the FDA District Offices in San Juan PR, Florida, Kansas City and New Jersey to bring facilities faced with Warning Letters, significant 483 and sterility concerns back into FDA compliance. His excellent track record with the FDA is a testament in his ability to foster teamwork and identifying the underlying Quality System issues. During his career, he has served as a Quality Professional for various industry stalwarts such as Baxter Healthcare, Bausch & Lomb Pharmaceuticals, Teva and Actavis in which he developed, implemented, managed, and streamlined the Quality Systems.
Bala Nayar, Ph.D.
Vice President, Specialty Product Development
Bala Nayar, Ph.D., joined Novel Laboratories/Gavis Pharmaceuticals in October 2012, heading up the Specialty Product Development department. He brings to Novel/GAVIS 30 plus years of pharmaceutical, OTC, healthcare and consumer product development experience and accomplishments. Over the years, Bala has been involved in product development from concept-to-market, project management, process development, scale-up and validation, clinical and bioequivalence studies, ANDA submissions and approvals, FDA Regulations, contract projects, due diligence, technical transfer and pharmaceutical business development. He has expertise in various dosage forms: semi-solids (ointments, creams, gels, pastes, and lotions), liquids and suspensions, suppositories, softgel capsules, tablets, nasal sprays, metered dose inhalers, sterile ophthalmic and injectable products. Prior to Joining Novel, Bala was Director of Product Development at Catalent Pharma Solutions where he led cross-functional product development teams at various U.S. and international Catalent sites and external partners for a portfolio of ‘high-barrier to entry’ generic drug products. Bala was Director of product development, process validation, technical transfer, clinical studies, CMC and contract projects at G&W Laboratories, a manufacturer of topical products and suppositories. Bala also worked as world-wide Director of R&D, Oral Care Products at Block Drug Co. (acquired by GSK), and at Procter & Gamble as a scientist and manager in technology, new product development and line extensions. Author of several publications and patents, Bala earned his Ph.D. in physical chemistry from Indian Institute of Science, Bangalore, India and did his post-doctoral research at the University of Southern California, Los Angeles.
Prasad Uppalapati
Vice President, Operations
Responsibilities: Planning, Purchasing, Manufacturing, Packaging, Engineering, Projects and Process scale-up. Background: Bachelors and Masters degree in Pharmaceutical Sciences. Prasad has 25 years of industrial experience in various leading pharmaceutical companies including: Lupin Laboratories, Ranbaxy Laboratories and Dr. Reddys Laboratories. Before joining GAVIS, he worked with Ranbaxy Pharmaceuticals Inc. for 11 years as the Senior Director Manufacturing responsible for the complete Manufacturing and Packaging operations of the company’s facilities in the U.S.A. He was a key member in the several multimillion-dollar expansion projects and played a pivotal role in planning, execution and commercialization of the plants in New Jersey and New York. During his tenure at Ranbaxy, he was directly involved in commercialization of multiple key Para IV filings of the company under exclusivities over the last seven years. Prasad is adept in projects planning, team building, scale-up and process optimization, automation leading to efficiencies, adapting various tools like SAP, Documentum, Trackwise and LMS in the operations function to enhance productivity and compliance.
Swapan Roychowdhury
Director, Analytical R&D and Quality Control
Roy joined GAVIS Pharmaceuticals in November 2010 as Director of Analytical R&D and Quality Control. With more than 30 years of experiences in the pharmaceutical industry, he directs GAVIS Analytical Services and Quality Control divisions to enhance and ensure compliance with regulatory, health, safety, and environmental guidelines, policies and procedures. Throughout his career, Roy has leveraged his technical expertise and management skills at many successful generic pharmaceutical firms including Actavis, Par Pharmaceuticals, Zenith/Goldline Pharmaceuticals, and Purepac Pharmaceutical Co. A shrewd problem-solver, Roy has developed analytic tests and quality systems for over one hundred ANDA submissions within highly competitive timelines. Roy earned an Executive Master of Business Administration in General Management from Rutgers University in 1988. He has taken numerous classes in Industrial Pharmacy.
James Garegnani
Director, Product Development
James Garegnani joined GAVIS Pharmaceuticals in August 2010 as Director, Product Development. With over 35 years experience in Pharmaceutical Research, including Product Development, Process Development, Technical Support, Technology Transfer, and Marketed Product Support of Solid and Liquid Dosage Forms, his career has given him a broad experience in development of generic, branded and OTC products. He has led cross-functional teams in managing multiple projects in an inter-departmental environment, has extensive experience in contract development and manufacturing, and has been a pioneer in developing modified release dosage forms – an area in which he is co-author of four patents. Prior to joining GAVIS, James was Director, Formulation and Process Development for KV Pharmaceutical with responsibilities for formulation and process development as well as managing two GMP pilot plants. Before leaving KV, James was responsible for establishing quality systems and procedures – including QbD and risk management – to ensure regulatory compliance for all product development activities in accordance with FDA and ICH guidelines as part of a quality management system. James earned his Bachelor in Chemistry degree from Monmouth College and has taken several management courses (MBA) from Southern Illinois University.
Arshad Kagalwalla
Vice President, Finance and Accounting
Arshad Kagalwalla joined GAVIS Pharmaceuticals in November 2008. Arshad has 20+ years of experience in Finance & Accounting and 10+ years in the generic pharmaceutical industry. He is currently responsible for the accounting operations, financial planning and analysis, budgeting and forecasting and Revenue management including contracts and pricing for GAVIS. Prior to joining GAVIS, Arshad held various positions at Par Pharmaceuticals within the Finance & Accounting department. In his role at Par as Associate Director, Research Finance, he managed an R&D budget in excess of $75 million. Arshad spent the early part of his career in public accounting and received his CPA in 2004. He is also a Chartered Accountant from India.
Dmitriy Kalika
Director, Management Information Systems
With over 19 years of experience in Pharmaceutical Information Technology, Dmitriy led the migration, integration and transformation of global IT solutions across functions and industries, delivering projects on-time, on-schedule and under budget. Prior to joining GAVIS, Dmitriy worked as a director of IT at Life Science Division at Computer Science Corporation, also as a Global IT Director with Image Solutions Inc, and as Senior Manager of IT with Actavis. At Actavis he led the computer network and technology integration of the U.S. acquired company Amide Pharmaceutical. Before Actavis acquisition, his role at Amide was Senior Manager of IT, where he implemented and maintained computer technologies in order to support dynamic grows of Amide. Dmitriy has pharmaceutical industry experience with extensive knowledge in cGMPs and FDA guidances as well as Bachelor’s degree in Chemistry from Kean University, and Master of Business Administration from Colorado Technical University.
Anu Radha Subramanian, Esq.,
General Counsel & Vice President
Anu left private practice and joined GAVIS at its inception in 2008 as its General Counsel.  While at GAVIS, Anu has managed a wide range of legal, human resources, risk management, and regulatory issues, working with people across virtually all company departments. She counsels the Company on various legal issues pertaining to ongoing and prospective business relationships, conducts complex agreement negotiations and manages patent and other litigation, in addition to heading GAVIS’s Human Resources department.  Anu is also in charge of a diverse group of premier outside counsel from large multinational firms such as White and Case LLP, Latham and Watkins LLP, Polsinelli LLP, Robins Kaplan Miller and Ciresi LLP, and Seyfarth Shaw LLP.
Aman Trehan, Ph.D.
Director, Intellectual Property
As Director of Intellectual property at Novel, Aman manages IP-related litigation which includes litigation strategy, interfacing with and supporting outside litigation counsel, and managing discovery and depositions. Aman also oversees Novel’s IP portfolio and leads IP-related due-diligence in the context of ANDA filings and supports business teams in identification of product opportunities.
Prior to joining Novel, Aman was the general manager of global intellectual property & strategic planning at Wockhardt, India, and prior to that he was head of intellectual property at the Pharmaceutical Technology Centre at Zydus, India. In addition to his time at Wockhardt and Zydus, he also worked at Alembic Pharmaceuticals and Ranbaxy Laboratories Limited.
Aman has completed specialized coursework pertaining to patent law in the U.S. and Europe. He is the recipient of the Pharmexcil Patent Award given by the government of India. He holds a doctorate in pharmaceutical sciences from Panjab University, Chandigarh, India.
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