LTR Pharma has today announced it has achieved manufacturing validation for its upcoming bioequivalence clinical study for its lead product, SPONTAN®.
The Company, in conjunction with its Contract Manufacturing Organisation (CMO), has now successfully met the essential criteria for a pivotal FDA clinical study – including stability testing, quality control checks, product purity and packaging integrity.
LTR Pharma Chairman, Lee Rodne, said:
“Completion of these critical steps signifies our Company’s commitment to adhering to the highest standards of product quality and regulatory compliance. We are optimistic about the potential impact of SPONTAN in the market and look forward to sharing our progress as we move closer to initiating the clinical trial.“
Patient recruitment for SPONTAN’s bioequivalence study is due to commence this month.