Development

Articles

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

Excipient-Certification Standards Presented for Comment

Sean Milmo is a freelance writer based in Essex, UK.

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

Report from Hungary

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Approaches in using small-molecule and peptide synthesis offer promise in widening the scope of drug candidates.

The Marriage of Small Molecules and Biologics

GlaxoSmithKline (GSK) identified certain over-the-counter (OTC) brands in its consumer healthcare business that the company plans to divest.

GlaxoSmithKline Plans to Divest Select OTC Brands

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

Week of Apr. 21, 2011: Company Notes: Axcan acquires Mpex Pharmaceuticals; Bend Research receives patent for improving bioavailability of low-solubility drugs; and More.

FDA recently published guidance for preventing the cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients with nonpenicillin beta-lactam antibiotics.

FDA Publishes Guidance for Preventing Cross-Contamination

Merck & Co. has formed a joint venture with the Mumbai-based specialty pharmaceutical company Sun Pharmaceutical Industries to develop, manufacture, and commercialize new combinations and formulations of branded generic drugs in emerging markets.

Merck Forms Joint Venture with Sun Pharmaceutical

Jane Wan is a freelance writer based in Singapore.

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

Report From China

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

Advancing Small-Molecule Synthesis

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.

Ingredients