Manufacturing

The US Food and Drug Administration published a draft annex to its ICH Q8 Pharmaceutical Development guidance that clarifies that document?s key concepts.

Novo Nordisk Drops Inhaled Insulin Product, Neurocrine Appoints CEO and President, More...

Noven Pharmaceuticals received a warning letter from the US Food and Drug Administration stemming from an on-site inspection of the company?s manufacturing facility in Miami, Florida, concluded July 2007.

Pfizer and Hikal signed a contract manufacturing agreement in which Hikal will supply active pharmaceutical ingredients.

Crucell and Sanofi Pasteur Sign Agreement, WuXi Pharma Names COO, More...

The US Food and Drug Administration released a draft plan for modifying its information technology infrastructure. The plan follows the renewal of the Prescription Drug User Fee Act (PDUFA IV).

Richard Spoor, senior vice-president of global procurement at Merck & Co., Inc., discusses the company's strategy and progress made in its supply strategy that involves increased outsourcing and implementing lean-manufacturing principles in its manufacturing network. Pharmaceutical Technology's senior editor Patricia Van Arnum moderates.

President Bush signed HR 2764, making appropriations to the US Food and Drug Administration during FY 2008, which ends September 30, 2008.

Merck Sells Facility to Cherokee Pharmaceuticals, Inflazyme Announces Senior Management Resignations, More...

The $6.3 billion Indian pharmaceutical industry is at a crossroad. Aiming to be the international home for quality drugs, which could in itself propel India's market to $20 billion by 2015 according to recent estimates, the generic hothouse is clearly moving beyond its earlier low-cost mindset.

Ireland seeks to maintain a leading position in pharmaceutical and biopharmaceutical manufacturing as it also builds its base in research.

Singapore moves forward with a plan to diversify its life science investment with projects in biologics and drug discovery.

There is a need for current cleaning validation methods to be used for topical formulations. The authors highlight the issues and challenges encountered.

The authors propose extending initial solvent screening for a single-solvent system to the cocktail solvent screening of binary and ternary solvent mixtures.

Puerto Rico seeks to build its standing in biopharmaceutical manufacturing and research as it retains its role in bulk pharmaceutical and dosage manufacturing for small molecules.

Researchers and process chemists share approaches in synthesis of active ingredients and pharmaceutical intermediates.

The outsourcing of clinical-trial materials grows as pharmaceutical companies adapt to a changing market.

Brief pharmaceutical news items for January 2008.

What should contractors and their clients bear in mind when they collaborate on a project?

The traditional pharmaceutical business model is disintegrating, but the new model is not much different.

Process efficiency is measured not only by what is kept, but also by what is thrown away.

Editors' Picks of Pharmaceutical Science & Technology Innovations

News, world briefs, facility roundup, events and other items for January 2008.

As FDA implements new drug-safety policies, manufacturers will focus on quality and pricing.

QbD, PAT, design space, what's it all about? This seems to be a common industry response to FDA's directional push.