USP is developing digital reference standards to integrate into modern digital environments, enhancing regulatory confidence ...

Katalyze AI builds Agentic AI systems for pharmaceutical manufacturing to improve yield, quality, and operational reliability. The company delivers AI agents that integrate with existing data ...

Drug Substance manufacturing is a critical component of pharmaceutical production, requiring precise processes, rigorous quality control, and innovative solutions to overcome various challenges. From ...

Operating under the FDA's 503B pathway, the Apex facility will prioritize the production of generic shortage-listed ...

For years, pharmaceutical scientists have sought to enhance bioavailability by transforming drugs from their crystalline state into more soluble, amorphous forms. Traditional methods like spray drying ...

Advancements in drug manufacturing technologies are reshaping global regulatory frameworks. This shift is largely driven by the integration of artificial intelligence (AI)-powered models, cloud-based ...

This investment comes as LGM Pharma experiences sustained growth in prescription drug projects, including 505(b)(2) and Abbreviated New Drug Application (ANDA) programs. The Rosenberg facility ...

Solubility is an essential characteristic for any oral medication, directly governing the drug’s bioavailability and efficacy. However, this requirement is running up against the growing ...

Pharmaceutical manufacturing encompasses all processes involved in the manufacturing and production of biological and medical products, botanical drugs, and herbs, as well as other pharmaceutical ...