We develop our new products by deploying a market driven approach to product development and focus on leveraging our advantageous existing market position to introduce new products in our target markets. We also focus on extending product lines of existing products in response to changes in market demand.
Our nutraceutical new product development efforts are focused on identifying new clinically-effective and safe product candidates, as well as creating line extensions of existing established products.
The new prescription pharmaceutical product candidates we select are identified based on a review of products which have been successful for major originator pharmaceutical companies in those market segments, and for which patents have either expired or are due to expire in the near term
In OTC products, we focus on the development of new products, as well as the development of line-extensions of current products. With respect to line-extension, we focus on the development of product quality, such as providing faster relief, and ease of use, and better formulations so that the products will be recommended to consumers by pharmacists.
New product selection involves interaction between all major departments of our business, including sales and marketing, product development, finance, and our scientific and medical affairs team, which focuses on evaluating the science and intellectual property behind potential new products. Following identification of a potential new product candidate, these teams will collaborate to evaluate and screen a new product proposal based on commercial, scientific, manufacturing, intellectual property and regulatory criteria, and formulate a final proposal and preliminary recommendation as to whether or not to commence a new product development process.
Once a new product proposal is approved, we will elect to develop new product candidates either in-house, or to procure from third parties already completed technical dossiers for submission of new products for regulatory approval. Our product development teams will proceed as follows:
Our Thailand-based product development team: Our business development team in Thailand is responsible for in-house product development activities and is focused on OTC and nutraceutical products. Its activities typically include product formulation development, analytical development and validation, process validation, testing, and gathering of other technical data needed to prepare a new product technical dossier (a compilation of scientific evidence, quality control and product information in relation to a proposed product, prepared in accordance with regulatory requirements) for regulatory filing.
Our India-based product development team: Our India-based product development team is responsible for outsourced product development activities and is generally focused on identifying and sourcing existing dossiers for new generic prescription pharmaceutical product candidates available for licensing from developers and partners, and which fit within our target therapeutic areas. As these prescription pharmaceutical product candidates have existing technical dossiers, we are able to proceed immediately to product registration in our markets.
The diagram below sets out a general overview of our new product development process
We consider that one of our principal competitive advantages in new product development is our ability to bring new products to our markets faster than our competitors, based on our extensive product development and registration experience in our markets, as well as our manufacturing and registration strategy. The period from new product identification through new product development, and up to the filing of a product registration, generally takes from 9 to 12 months. As outlined in section 3.4, the period from new product registration through product approval and launch varies from country to country and may take up to 12-18 months or more. As a general matter, pharmaceutical products require a longer registration period than nutraceutical and OTC products, and a speedy registration process of a product in Australia may result in a shorter period for registration in our certain markets.