<h1>Global CDMO alliance to co-develop and manufacture NCE-1 and complex APIs with unified quality and regulatory strategy</h1> Two pharmaceutical companies have entered a multi-year CDMO agreement to jointly develop, scale up, and manufacture high-value NCE-1 and late-stage complex APIs for regulated and semi-regulated markets. The partnership grants exclusive and semi-exclusive rights for multiple APIs and covers end-to-end GMP manufacturing, validation, and global supply. The parties will collaborate on regulatory DMF filings across US, EU, LATAM, MENA, and APAC, sharing technical dossiers and jointly managing CMC documentation, stability studies, validation programs, and regulatory interactions. The framework initially covers five API programs, including novel CNS, metabolic, and specialty therapeutics, and establishes unified quality, compliance, and audit-readiness standards for major regulatory agencies.