Northvale pharmaceutical company reports positive results from study

October 30, 2018 by  

Elite Pharmaceuticals, a Northvale company, recently revealed it had seen positive results from studies it conducted for a generic antibiotic developed in association with SunGen Pharma.

The results indicate the generic the companies developed was bioequivalent to the brand-name product.

Bioequivalence is defined as the relationship “between two preparations of the same drug in the same dosage form that have a similar bioavailabilty,” meaning they are absorbed into a physiological system at the same rate. In other words, the generic drug will act in the same way as the brand name preparation, which should represent a significant price savings for customers. Companies that develop complex products like this could flyer printing to create instruction sheets for consumers.

Elite Pharmaceuticals is a specialty company that develops generic products for a specific product niche, including opioids that deter substance abuse. This is the second time Elite and SunGen have developed an antibiotic together. The first was successful in bioequivalence, as noted earlier this year, and now the second drug has also given good results.

In addition, the U.S. Food and Drug Administration (FDA) recently finished a preapproval inspection of two products co-developed by the two companies. Elite’s CEO and chairman, Nasrat Hakim, said that working together, Elite and SunGen have been able to develop a total of four products that have passed bioequivalence studies. Two of the four have already been filed with the Food and Drug Administration, and the other two will soon follow suit.

Comments