Drug Substance manufacturing is a critical component of pharmaceutical production, requiring precise processes, rigorous quality control, and innovative solutions to overcome various challenges. From ...
New draft guidance issued by the US Food and Drug Administration (FDA) is intended to clarify which changes to a pharmaceutical company's manufacturing process must be reported to federal regulators, ...
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 ...
The London-based company said its in-space microgravity crystallization process could enable cancer treatment to be delivered ...
SHANGHAI, SHANGHAI, CHINA, April 30, 2026 /EINPresswire.com/ -- In today’s life sciences industry, moving a drug ...
What is Pharma 4.0? The term Industry 4.0 refers to the fourth industrial revolution, associated with the application of advanced technologies that have dramatically changed the landscape of ...
Based on FDA Office of Generic Drugs guidance previously announced, NRx has transmitted an initial GMP manufacturing order to its US-based manufacturer. NRx has completed confirmatory GMP audits of ...
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 ...
Regulatory approval is a major milestone in the drug development process, but it is not the final chapter in the journey.
Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...