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news.Clinical stage biopharmaceutical company, Ampio Pharmaceuticals has signed a definitive agreement with Ethypharm to manufacture Zertane, Ampio's drug to treat premature ejaculation.
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Zertane, which is an orally disintegrating tablet (ODT) is manufactured by Ethypharm under patented processes jointly owned by Ethypharm and Ampio.
As part of the agreement, the companies will complete the IND to conduct pivotal trials of Zertane in the US, which also includes the delivery of the final packaged drug and documentation necessary for registration and approval processes with other regulatory agencies.
The companies will also finalise the registration package for approval of Zertane by the TGA in Australia, which will again be used for approval in South Korea and Brazil.