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news.PharmaGap has completed quality audits for cGMP (current Good Manufacturing Practices) grade peptide at the manufacturer's site.
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According to the company, the submission would pave the way for an Investigational New Drug (IND) Application in the US.
The manufacturers have produced research grade GAP-107B8 and variants for PharmaGap’s in vitro and in vivo testing and development program over the past 12 months.
The future testing includes scale-up of liposomal formulations and formal GLP safety-pharmacology and toxicology testing for GAP-107B8 during 2012.