A generic drug manufacturer refers to a reference listed drug (RLD) (an approved listed drug) to inform the US Food and Drug Administration (FDA) what its product would be like. Usually, it is a “brand” product (new drug application [NDA] holder) until it is in the market. The RLD is used as a basis for submitting an ANDA; in other words, an abbreviated new drug application (ANDA) for a generic drug is a duplicate of its RLD. There are certain key challenges and solutions for the industry.
Given the current outbreak of COVID-19 and the impact virus is having on global communities, customers, employees and families, our hearts and thoughts go out to all of those who have been affected by this event and we appreciate all the healthcare workers, local communities, and governments all over the world that are working to fight this virus.
Hope you, your family and loved ones are well and safe in these challenging times.
Having restructured and transformed B2B, B2C, B2B2B, B2B2C, the unique opportunity is to now transform a global B2B2P company, where Patient First is the driving mission, as we support Life Sciences Companies under the guidelines laid down by Regulators like; Food and Drug Administration USA, Medicines and Healthcare products Regulatory Agency UK, European Medicines Agency etc.