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

Katalyze AI today announced the launch of Katalyst, an AI agent purpose-built for pharmaceutical manufacturing. Designed for ...

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

Pharmaceutical manufacturing steps are often isolated in space and time. The synthesis, isolation and purification of the drug substance (DS) and the formulation of the drug product (DP) may be ...

A CDMO championing a commitment to patients may sound like lip service or branding, but truly patient-centric CDMOs offer ...

HRV Pharma’s innovative “virtual manufacturing” model connects FDA-approved facilities to prevent prescription shortages and ...

Designing an efficient platform is crucial for any industrial process. This design process is known as process development, and it has become increasingly important in the pharmaceutical industry at ...

Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...

The U.S. Food and Drug Administration has awarded the National Institute for Pharmaceutical Technology and Education a grant worth up to $35 million over the next five years to improve drug ...

Pharmacy benefit managers received substantial attention during 2024. Congress and regulating agencies including the FTC and HHS scrutinized PBM business practices and related profits. As a new ...

Zee Laboratories supplies medicines to government hospitals and institutions such as AIIMS, as well as to central and state ...