ANI, IDT Australia Form US Generics Pact
ANI Pharmaceuticals, Inc., a specialty pharmaceutical company, and IDT Australia, a specialty generics company, have entered a partnership to commercialize up to 18 previously marketed US generic drug products. ANI has paid $1.0 million to IDT for exclusive rights to commercialize the products in the North American market. ANI will receive an undisclosed percentage share of the net profits upon commercialization. ANI estimates that the US market for these products at $538 million.
IDT anticipates filing of a CBE-30 (changes being effected supplement) with the US Food and Drug Administration (FDA) for the first product in the fourth quarter of 2015. A CBE-30 involves notification to the the FDA for any change to a product that has a moderate potential to have an adverse effect on identity, strength, quality, purity or potency of the product as they may relate to the safety or effectiveness of the product. Examples of such changes include production process, quality controls, equipment, facilities, or responsible personnel. Distribution of product made with the change may commence 30 days after the FDA's receipt of a CBE-30 supplement, or immediately upon FDA receipt of a CBE supplement, according to information from the FDA.
Source: ANI Pharmaceuticals