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When choosing an elastomer for a generic drug product, is it necessary to stay within the same elastomeric class as the innovator? Based on our experience, there is no advantage to maintaining the same class of elastomer as the innovator because physical and chemical differences are on a formulation-specific basis. There is no indication from regulatory bodies that speed to market can be increased by maintaining the innovator elastomeric class. We have found that regulatory bodies are much more concerned that the generic drug manufacturer has an understanding of their packaging components through scientific processes and data generation that show the chosen packaging does not affect the safety, purity and efficacy of the drug product.
Ultimately, it is important to select an elastomeric formulation that will meet the needs of your drug product and its end use. There is no one-size-fits-all formulation, so component selection must be made with the critical quality attributes that are most important to each unique application in mind.