Outsourcing

The IPEC is soliciting public comment about a draft plan for the independent certification of manufacturers and suppliers of pharmaceutical excipients.

Eastern Europe's pharmaceutical leader, Hungary, is working to maintain its number-one status while also pursuing new avenues, especially in biopharmaceuticals.

Lessons from the earthquake in Japan show the vulnerability of the bio/pharma supply chain.

FDA, NIH and industry seek new strategies to spur drug development and promote access to therapies.

Many factors affect research results.

Axcan acquires Mpex Pharmaceuticals; Bend Research receives patent for improving bioavailability of low-solubility drugs; and More.

Courts and Congress seek to reshape policies and programs.

The contract-research industry in China is growing in leaps and bounds, and Big Pharma is leading the way.

PhRMA efforts of industry's R&D scientists.

Chemocatalytic and biocatalytic routes play an important role in improving the manufacture of intermediates and active pharmaceutical ingredients.

The complexity of third-party external supply networks requires new ways to manage them.

In any industry, inspections can be a pain, and pharma is no exception.

Companies engaged in global mergers and acquisitions may be hearing from the Department of Justice more often to ensure that corruptive practices are not taking place.

The need for greater process understanding raises the bar for suppliers.

Bob Weaver, president of HunterLab, discusses current trends and challenges.

On Mar. 23, 2011, sanofi-aventis offered $7 billion in notes to fund its acquisition of Genzyme. The notes are offered in six tranches scheduled to come due between 2012 and 2021, and the interest rates range from 0.05% to 4%.

Pfizer is considering divesting some of its businesses to maximize their value, according to remarks made by Mikael Dolsten, Pfizer's president of worldwide research and development, at a Barclays Capital investor conference last Thursday.

The Bulk Pharmaceutical Task Force (BPTF) of the Society for Chemical Manufacturers and Affiliates (SOCMA) and the European Fine Chemicals Group (EFCG) of the European Chemical Industry Council (CEFIC) are calling on FDA to mandate inspections of foreign active pharmaceutical ingredient (API) manufacturing sites with the cost borne by those sites being inspected. Both organizations have indicated a willingness to pay fees for these inspections when performed on their member-owned facilities that are located outside the United States.

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

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

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

Brazil develops its first national plasma fractionation plant.

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

Q&A with Robert Hardy, chief executive of Aesica

The author provides an overview of QbD implmentation for biopharmaceuticals.

The power of emerging markets is reflected in the pharma's sales and production positions.

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

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

Gilead to Acquire Calistoga; Bayer Healthcare Appoints Former Pfizer Exec; and More.

Company and People Notes: sanofi to Acquire Genzyme; Lilly Makes Senior Appointments; and More.