Manufacturing

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.

How much do you know about parallel trade? Perhaps you may have heard someone mention these words and have then switched off. In a sense, it's hardly surprising given the fact that most media coverage centres on interpretation of complex legal cases. By the time you reach the end of these types of articles, you can't work out what the mentioned companies were arguing about in the first place and on which technical details the case was judged. Yet, time after time, a legal ruling on a parallel trade issue rockets to the front pages of the pharmaceutical press and even, occasionally, the mainstream media.

The pharmaceutical industry in Asia is gearing up to be at the centre of the global market. Most pharmaceutical companies in the region expect this shift to happen fast. Not only is Asia set to become the largest pharmaceutical market in the world, but many Asian territories will be the powerhouses of the industry. By 2020, the worldwide pharmaceuticals market could be worth around $1.3 trillion, with China being the second or third biggest market.