Pharmaceutical Technology Europe - March 2012 - (Page 8)

NEWS BITES Pfizer’s Chinese generic deal EMA guidance on genetic variability The EMA has published a guideline that addresses the influence of patients’ genetic variability on drug pharmacokinetics. The guideline on the use of pharmacogenetic methodologies in the pharmacokinetic evaluation of medicinal products clarifies the requirements for drug developers to analyse the effect of genetic variability on their medicines. It is expected to come into effect on 1 August 2012. According to the guidance, studies of the effect of pharmacogeneitcs will usually be required when the magnitude of interindividual variation in drug exposure is high enough to potentially affect a medicine’s safety and/or efficacy. PharmTech.com/GeneticGuidance Joint venture for South African API plant The South African government is involved in talks with the Swiss biopharmaceutical company Lonza regarding a joint venture to construct the country’s first plant to manufacture APIs for antiretroviral (ARV) medicines. The government is investing approximately 1.6 billion Rand ($206.6 million) in the joint venture. Most of the country’s medicines are manufactured by local pharmaceutical companies, but all of the APIs for ARV medicines are imported. The South African government hopes that the venture will reduce the country’s dependence on imports and mitigate its deficit, to which pharmaceuticals are the sixth largest contributor. PharmTech.com/ApiPlant 2 SPECIAL FEATURE 11 PARAMETRIC RELEASE 7 REDUNDANT FILTRATION 12 COLUMN CRUNCH Pfizer has signed an agreement with the Chinese biopharmaceutical company Zhejiang Hisun Pharmaceuticals with the objective of establishing a $545-million joint venture to develop and commercialise branded generic medicines in both China and the global market. According to the framework agreement, the potential joint venture will be called Hisun Pharmaceuticals Co. The companies will be focusing on the potential for manufacturing cooperation, broader commercialisation of medicines through local and global sales and marketing infrastructures, and the R&D of off-patent medicines. After the joint venture has been formed, both companies will be able to contribute selected existing products, manufacturing sites, cash and other relevant assets. PharmTech.com/ChinaDeal Warning letter for Merck KGaA The FDA has sent Merck KGaA a Warning Letter regarding cGMP violations identified at three of the company’s European facilities: MS-Corsier-sur-Vevey, MS-Aubonne and MS-Tiburtina. The letter was issued in response to inspections conducted between 27 June and 1 July 2011. Merck KGaA provided responses to the inspection reports last year, but the FDA found these to be insufficient. FDA that some of the cGMP violations impacted all three Merck KGaA facilities, and that “The lack of compliance with cGMPs may lead to production problems and adversely impact the availability of critical medically necessary products that meet required quality standards”. PharmTech.com/MerckLetters 8 NEWS BITES 13 PEER REVIEW 9 BLOG 14 TOP TECH http://www.PharmTech.com/ChinaDeal http://www.PharmTech.com/GeneticGuidance http://www.PharmTech.com/MerckLetters http://www.PharmTech.com/ApiPlant

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - March 2012

Pharmaceutical Technology Europe - March 2012
Contents
Innovations, drivers and trends in adjuvant filtration
Focus: Redundant filtration
News Bites
Blogs Abridged
Interview: Parametric release and real-time release testing
Column Crunch: Counterfeits and outsourcing trends
Evaluating drug impurities
Top Tech

Pharmaceutical Technology Europe - March 2012