Development

Articles

Wavelength Pharmaceuticals expanded production of APIs for certain pharmaceutical products needed to manage respiratory critical care patients in the COVID-19 pandemic.

Wavelength Pharmaceuticals Expands Supplies of Drug Ingredients for Managing COVID-19 and Adds API CDMO Services

The technology center is dedicated to developing greener, safer chemistries for manufacturing pharmaceutical raw materials and intermediates.

PharmaBlock Opens New Chemistry and Engineering Technology Center in Zhejiang, China

Bayer, Novartis, Mylan, Teva, report that they are working on supply.

Suppliers Plan for Chloroquine Capacity

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Formulating fixed-dose combination drugs proves more complex than simply adding one ingredient to another. 

Characterizing APIs is Essential for Combo Drug Formulations

Cambrex reports that the acquisition by the investment group will facilitate ongoing growth.

Cambrex Sale to Premira Funds Affiliate Closes

Several factors must be considered when reformulating APIs for pediatric, geriatric, and other specialty patient populations.

Adapting APIs for Specialty Dosage Forms

Agnes Shanley is senior editor of Pharmaceutical Technology.

Emphasizing the need for senior management to take cGMP compliance seriously, the agency pointed to “improvisational” validation procedures, lack of compliance with written procedures, as well as  inadequate process control, root cause analysis, and corrective and preventive action (CAPA) in its warning letter.

FDA cites repeated, fundamental cGMP issues in its warning letter to Torrent Pharmaceuticals

Limited guidance and numerous challenges create confusion about the scope and timing of stability testing for drugs in development.

Stability Testing for Small-Molecule Clinical Trial Materials

Lina Cogan is senior director of global sourcing and procurement for LGM Pharma.

Hamilton J. Lenox is senior vice-president, business development for LGM Pharma.

Selwyn Lustman is senior vice-president global sourcing and procurement for LGM Pharma.

Sourcing hard-to-find ingredients and establishing a reliable supply chain can stretch the resources of a small- to mid-size pharma company. 

Planning a Successful API Procurement Strategy

Jonathan Loughrey is head of screening, Cambrex Edinburgh.

An understanding-during early development-of the solid form landscape of an API can enhance product quality and manufacturing processes.

API Synthesis and Manufacturing, Small Molecule