Unigene Granted Approval for Improvement to Calcitonin Manufacturing Process

Unigene has announced that the FDA has approved the use of a new clone for the manufacture of calcitonin, the active ingredient in Fortical, the company’s nasal spray product for the treatment of osteoporosis.

This is the second improvement to the production process approved by the FDA this year. The combination of these improvements is expected to increase batch yields of the product by a factor of three.

Warren Levy, president and CEO of Unigene, said: “”e believe that these improvements to our manufacturing process will reduce our future costs and allow us to increase capacity for Fortical. Also, FDA approval of our improved manufacturing process should provide additional capacity for other peptide products.”