Experience Is Our Strength
At Impax Laboratories we have created a strong platform for growth built on a broad base of drug delivery expertise, formulation technology and experience in product development.
Impax Generics Division has a wealth of experience and a track record of product approvals. Investing in our people is a key ingredient to our success and a benefit in building a strong organization.
Within our Generics Division:
The following information summarizes our generic pharmaceutical product development activities since inception through December 31. 2016:
- 136 ANDA approved by the U.S. Food and Drug Administration (FDA), including four tentatively approved (i.e., satisfying substantive FDA requirements but remaining subject to statutory restrictions). In addition, we have rights to market and/or share in profits to 16 approved ANDAs held by our third party alliance partners.
- 25 applications pending at the FDA that represent approximately $14 billion in 2016 U.S. product sales.
- A number of products in various stages of development for which applications have not yet been filed.
Impax Specialty Pharma is engaged in the development, sale and distribution of proprietary pharmaceutical products that we believe represent improvements to already-approved pharmaceutical products addressing central nervous system (CNS) disorders and other select specialty segments.
Within our Specialty Pharma Division, we market:
- CNS products for the treatment of Parkinson's disease and migraines.
- Anthelmintic products for the treatment of pinworm, whipworm, common roundworm, coon hookworm and tapeworm.