Global Pharmaceuticals (Generics)

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Our Generic Pharmaceuticals Division

Impax has developed a portfolio of generic pharmaceuticals through the filing of Abbreviated New Drug Applications (ANDAs). Our generic product development strategy is based on a combination of speed to filing and a legal strategy primarily predicated upon non-infringement of established brand name pharmaceuticals. We are focused on targeting high-margin, first-to-file or first-to-market product opportunities.

Global’s multi-source product line consists of a growing range of solid oral prescription pharmaceuticals, distributed primarily through drug wholesalers, distributors, warehousing chains and managed healthcare organizations.

The organization continues to invest in state-of-the-art equipment, people and facilities, in order to provide the highest level of customer service. Our quality assurance team works closely with our suppliers to ensure purity, consistency and quality of products, and we strive to bring value to our customers with innovative products in key therapeutic areas.

Global has a dedicated team of experienced professionals handling customer orders and inquiries that work to not only meet the expectations of our customers, but consistently deliver beyond expectations. Every member of our team is committed to the success and profitability of our customers. We have set the highest standards for our products, services and people, and are proud of the organization we are building.

Global Pharmaceuticals develops, manufactures, sells and distributes generic pharmaceutical products primarily through four sales channels:

• Global product sales channel, for generic pharmaceutical prescription products we sell directly to wholesalers, large retail drug chains, mass merchandisers and mail-order pharmacies
• Private Label sales channel, for generic pharmaceutical over-the-counter (OTC) and prescription products we sell to unrelated third parties who, in turn, sell the product under their own label
• Rx Partner sales channel, for generic prescription products sold through unrelated third-party pharmaceutical entities pursuant to alliance agreements
• OTC Partner sales channel, for sales of generic pharmaceutical OTC products sold through unrelated third-party pharmaceutical entities pursuant to alliance agreements.

Product Development Strategy

Our generic product development strategy is based on two opportunities we've identified in the generic pharmaceutical marketplace:

• Controlled-Release Generic Products
  Through our controlled-release drug delivery technologies and formulation skills we develop bioequivalent versions of selected brand name pharmaceuticals. Controlled-release pharmaceuticals generally have technically challenging drug delivery requirements. We employ our proprietary processes and formulation expertise to develop products that reproduce the brand name product’s physiological characteristics, but do not infringe upon the brand product’s patents.
• Specialty Generic Products
  Products that present one or more competitive barriers to entry, such as difficulty sourcing raw material, complex formulation or development characteristics, or special handling requirements.

Our Products

We currently manufacture and market 102 generic pharmaceutical products, which represent dosage variations of 30 different pharmaceutical compounds through our Global Pharmaceuticals Division; another 16 of our generic pharmaceutical products representing dosage variations of four different pharmaceutical compounds are marketed by our alliance agreement partners.

Our Pipeline

Our current generic pipeline has never been more valuable than it is today with more first-to-file and first-to-market opportunities either pending or under development than ever before. We currently have 39 pending ANDAs with at least 7 ANDAs having first-to-file or first-to-market potential.

We are also working on an additional 79 products under development with many having the potential to be first-to-file or first-to-market opportunities. For 2011, our internal/external goal is to file at least 12 new applications with at least 3 of these being first-to-file or first-to-market opportunities.