Manufacturing

Pfizer Completes King Acquisition; ViiV Healthcare Names Chairman; and More.

FDA recently sent sanofi-aventis two Warning Letters for its facilities in Frankfurt am Main, Germany, and Bridgewater, NJ.

With a regulatory pathway for follow-on biologics, industry is wondering what FDA will do next.

The 2011 show presents ideas for package designs and equipment options for packaging lines.

New product reviews from March 2011.

Indian manufacturers are not a near-term threat to Western CMOs, but may be long term.

The authors evaluated the manufacturing data of 40-mg tablets of furosemide, a potent diuretic.

A revised book on process analytical technology could be valuable to novices and experts.

Brazil develops its first national plasma fractionation plant.

The authors investigated the tableting properties of PanExcea MHC300G, a high-performance excipient.

A single, global tooling standard would offer many benefits, but one has been slow to emerge.

The author describes key considerations for drug manufacturers when evaluating packaging partners.

Q&A with Robert Hardy, chief executive of Aesica

Social media tools have taken over many aspects of our lives, now including regulatory info.

The author provides an overview of QbD implmentation for biopharmaceuticals.

Just when things seem to be looking up, the unexpected problem occurs.

The authors review a compliance-by-design approach to quality systems.

Pharmaceutical Technology's annual survey on equipment and machinery reveals the spending levels and type of spending made in 2010 and planned for 2011.

The author challenges current detection methodologies.

As drug shortages make headlines, FDA tests the Sentinel safety system and its efect on healthcare.

This report provides plans for the USP Council's work in the 2010-2015. This articles contains online bonus material.

INTERPHEX 2011 aims to address the industry's unique characteristics.

The authors outline the key decision points FDA must consider in putting forth a US regulatory pathway for biosimilars.

This article is Part I of a three-part series on biopharmaceutical issues in public health, government, and developing-world markets. Part 1 focuses on drug-development. Part II, which examines manufacturing, appeared in the April 2011 of Sourcing and Management. Part III, which analyzes distribution and administration,appeared in the May 2011 issue.

Contract manufacturers and fine-chemical suppliers announce capacity expansions and service enhancements of Informex.