Authorized Generics: Q&A with Greenstone's Jim Cannon

Jim Cannon, Greenstone VP and general manager

With generic drugs saving the healthcare system millions of dollars, Drug Store News caught up with Jim Cannon, Greenstone VP and general manager, to discuss authorized generics.



DSN: How is Greenstone related to Pfizer? Does Greenstone only make authorized generics for Pfizer brand products?



Jim Cannon: Greenstone is a wholly owned subsidiary of Pfizer and most of our products are authorized generics for Pfizer brand products, but not all. For example, we have recently launched several authorized generics of Allergan’s ophthalmic line. Greenstone began in 1993 as a temporary competitive strategy of The Upjohn Company. We have grown from a portfolio of two to three products to become a top ten generic player in the United States.



Today Greenstone offers a broad portfolio of generics featuring more than 60 medicines with more than 195 presentations in various formulations, including solid oral dose products, oral solutions, ophthalmic solutions and topical creams.



DSN: What is an authorized generic?



Cannon: An authorized generic drug is identical to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.

In general, an authorized generic is made and sold under an NDA. This means it has the same efficacy and safety profiles, and contains the same active ingredients and inactive ingredients as the brand-name drug. An authorized generic and the brand-name drug both have the same strength and act the same way in the body. The differences are typically characteristics such as markings on the tablets, labeling and packaging.



DSN: How is Greenstone working to navigate the challenges facing generics manufacturers? Specifically, how is Greenstone working to navigate the challenges facing generics manufacturing, including FDA approval backlog and rising costs from increased regulatory scrutiny on quality?



Cannon: As Pfizer’s generics provider, we enjoy the advantages and resources of being part of a very large and respected global pharmaceutical manufacturer while retaining a nimble and decisive culture. Greenstone and Pfizer share a commitment to exceptional quality and manufacturing excellence, as well an extensive regulatory experience. Greenstone strives to excel in bringing products to market and specializes in difficult-to-manufacture products. All of these attributes help us to rise to the challenges of FDA approvals, rising costs and stringent quality requirements. As products continue to lose patent exclusivity, Greenstone is well-positioned to deliver growth.