Lannett Company Inc has executed a supply agreement with a specialty chemical manufacturer for an exclusive supply of raw material, (also known as an active pharmaceutical ingredient (API)) for a new generic drug. The Company intends to develop a generic formulation for a brand-name drug, and submit an abbreviated new drug application to the Food and Drug Administration (FDA). The brand-name drug has no current generic substitutes available. At this point in time, the Company does not want to publicly identify the name of the drug for competitive reasons. Since the Company has no control over the FDA review process, the Company is unable to anticipate whether or when it will be able to begin commercially producing and shipping the product.
The Company concentrates its drug development efforts on products it expects will have limited or no generic competition. It has also initiated an aggressive campaign to develop relationships with key material suppliers for exclusive supply of API's. According to Arthur P. Bedrosian, Lannett's President, "This is the third supply agreement Lannett has entered into and we anticipate further agreements."
The Company expects to be able to continue to build on these relationships, with the ultimate goal of expanding its line of products for sales to the drug distribution industry. The Company has succeeded in expanding its customer base over the past two years to the majority of retail drug chains, wholesalers, distributors, managed care, pharmacy benefit managers and mail order pharmacies.