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Pharma/fine chemicals roundup—8 January 2014
5:04 AM MST | January 8, 2014 | By DEEPTI RAMESH
FDA and European Medicines Agency team up for facility inspections for generics
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA; London) announced that they will conduct joint facility inspections for generic drug applications submitted to both agencies. They launched a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. Studies submitted for generic drug applications must demonstrate scientifically that a generic drug is ‘bioequivalent’, which means that the generic drug performs in the same manner as the brand name drug. The FDA and the regulatory authorities in the European Union (EU) inspect facilities that conduct these studies to ensure data submitted to the agencies are reliable. The EU member states initially involved in this initiative are France, Germany, Italy, the Netherlands and the United Kingdom.
“Our continued collaboration with the EMA and the EU enhances our ability to leverage inspection resources and helps us meet the challenges of increased globalization in drug development,” says Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
Bayer and Peking University establish research center in Beijing
Bayer HealthCare and Peking University (Beijing) have signed a comprehensive collaboration agreement on a three-year strategic partnership to promote translational research for drug discovery. The two partners, under this agreement, will establish a joint research center at Peking University under the name Bayer HealthCare/Peking University Center of Translational Research for Drug Discovery. The collaboration will focus on applying basic research to drug discovery in the therapeutic areas of cardiology, oncology, hematology, and gynecological therapy, as well as technological research along the drug-discovery and -development value chain.
Capsugel’s Encap drug delivery announces collaboration with Lipocine
Encap Drug Delivery (Livingston, UK), part of Capsugel’s (Morristown, NJ) dosage form solutions business unit and a leader in liquid-fill hard capsule development and manufacturing, has entered into a collaboration with specialty pharmaceutical company Lipocine (Salt Lake City, UT) to manufacture Phase 3 clinical trial and registration batches of Lipocine’s oral testosterone product, LPCN 1021. The product will be manufactured in the company’s high-potency suite at the Livingston R&D site. “Encap has built its profile over the last few years in product development and clinical trial manufacturing. This collaboration highlights our long-standing and significant expertise in commercial-scale manufacturing and our ability to handle high-potent active pharmaceutical ingredients [HPAPIs],” says Stephen Brown, managing director at Encap Drug Delivery.
Beyond IHS Chemical Week:
US FDA 483 and 23 observations for Hospira's troubled Indian plant
A Hospira plant in India that was issued with a US FDA warning letter last summer has been criticized by the agency again following an inspection last month. The company revealed last month that the FDA completed an inspection on 10 December of its Irungattukottai plant, near Chennai, India, and issued the site a Form 483 with 23 observations.
FDA alerts drive quality requirements upwards in pharma industry: Albert Stevens, IMCD Group
from Business Standard, India
In this interview, Albert Stevens, VP Asia, IMCD Group, one of the leading global distributors of specialty chemicals, considers India to be one of the key growth drivers in Asia for the group.