Feb. 02, 2012

What Pharma Can Learn from the Tobacco Industry

Billion-Dollar Industry - The illicit trade in counterfeit pharmaceuticals is worth an estimated $200 billion a year and has obvious implications for public health. A range of anti-counterfeiting measures are currently underway or under consideration. These measures include, at country level, reimbursement initiatives, e-pedigree and covert authentication, and, at EU level, co-operation agreements and the directive on Falsified Medicines. moreJan. 25, 2012

Interoperability in the Pharma Supply Chain

Framework - When asked, most people say that they believe regulations should avoid dictating specific technologies but instead should dictate desired outcomes and let industry figure out the best technologies to achieve them. The concern is usually that technologies mandated in regulations will inevitably grow old and the regulated industry would then be blocked from taking advantage of newer, more innovative technologies. moreJan. 25, 2012

Switching API Sources

Costs of Switching - Competitive bidding has historically been used to reduce the cost of purchased materials. In the case of active pharmaceutical ingredients, it is not always clear that lower ingredient prices will generate a satisfactory return on the effort to qualify an additional source of supply. Steven Harvey of PL Developments examines the costs of a switch. Drivers And Impediments moreJan. 24, 2012

Counterfeit Pharmaceuticals

The War Continues - The European Union's Falsified Medicines directive, ratified in 2011, was arguably the most significant landmark to date in the war on fake drugs.

The law will require (from around 2016) a traceable safety feature and tamper evident closure on almost all prescription medical products sold in the EU. Mark Davison, CEO of Blue Sphere Health, examines some of the approaches his customers are using to comply with the directive and other legal obligations around the world. moreJan. 13, 2012

GDUFA: Who Will Benefit?

The pharmaceutical supply chain is increasingly globalized. It is estimated that 80% of the active ingredients used in generic medicines marketed in the U.S. are manufactured in foreign countries with half of this volume originating from China and India.
moreOct. 26, 2011

API Sourcing in China and India

Paradigm Shift - The number of API manufacturers in India and China focused on supplying active ingredients to regulated markets has grown considerably over the past few years.

Much of this growth can be attributed to the increasing focus by dose companies based in regulated markets to find ways of lowering costs, including those for active ingredients. Many of these new API manufacturers in India and China have also invested in finished dose development and manufacturing, frequently utilizing their own active ingredients.
moreOct. 25, 2011

Pharma’s Future with a Disaggregated Supply Chain

New Rules -The game has changed for the global pharmaceutical industry. Numerous forces are shaping this new pharmaceutical era: The rise of emerging markets, increasing price pressure and expiring patents are just some of the factors forcing pharmaceutical companies to change the way they operate and how they manage their value chain.
moreOct. 19, 2011

Non-compliance is on the Rise

Steady Increase - All who follow industry trends will have noticed an increase in regulatory actions related to non-compliance issues. We can see this in the increased issuance of inspectional observations - or 483s - by the U.S. Food and Drug Administration (U.S. FDA) and by the withdrawal of certificates of suitability (CEP) certifications by the European Directorate for the Quality of Medicines and Healthcare (EDQM). more