NOVAST Laboratories, a Nantong-based pharmaceutical company, was founded in 2005 by Dr. Guohua Zhang, Mr. Prasadraju Pinnamaraju and the management team.
Dr. Zhang continues to lead his experienced and multinational management team in research, development, production and supply of prescription drugs. All NOVAST prescription drugs are pedigreed with independent intellectual property rights for the global market.
NOVAST maintains a critical focus on technological research and product development of drug-delivery systems and extended-release prescription medications by applying the concept of "quality by design" to the entire process of research, development, production and supply.
The 40,000 square meter current Good Manufacturing Practices (CGMP) facility is located in Nantong Free Trade Zone. The manufacturing plant has annual production capacity of at least 2 billion tablets and at least 1.76 billion capsules to provide high quality drugs worldwide.
In 2012, Philith™, our first oral contraceptive product was successfully launched into the US market. This first NOVAST oral contraceptive quickly achieved zero breakthrough into the US mainstream oral contraceptive prescription drug market and has grown since.
The last 5 FDA inspections resulted in no 483 observations. In addition, currently 5 Novast manufactured products have been designated as RS (Reference Standard) products by the United States Food and Drug Administration (US FDA).
NOVAST had successfully submitted over 50 high-barrier-entry Abbreviated New Drug Applications (ANDAs) into US FDA.
Of these, 40 unique pharmaceutical prescription products have been approved by US FDA, including 10 high-tech-barrier extended-release drugs developed by NOVAST for one of our marketing partners.
Of those approved submissions, nearly 40 products have been successfully launched into the US mainstream prescription drug market. By relying on our leading-edge drug processing technology and design, many of our products have taken more than significant market share in the US marketplace. This is evidence of the superior quality, efficiency and value of NOVAST products within the globally competitive pharmaceutical market.
In April 2021, NOVAST passed the on-site verification for Drug Registration by National Medical Products Administration (NMPA) of China and GMP Inspection by Jiangsu Medical Products Administration (JSMPA). In the third and fourth quarters of 2021, three high-barrier-entry drugs “sharing the same manufacturing line” have been approved by the NMPA of China with launching anticipated in 2022.
Additionally, based on strong R&D capabilities, NOVAST has established long-term partnerships and growth opportunities with many large pharmaceutical companies around the world to provide outsourcing services of innovative drugs to contract research organizations (CRO) and Contract Manufacturing Organization (CMO).
In summary, NOVAST provides high-barrier-entry drugs and innovative pharmaceutical preparations for both domestic and international markets. We strive to create reliable, high-quality and effective prescription drugs for all patients.
