Manufacturing

Ranbaxy Laboratories (Gurgaon, Haryana, India) responded to an investigation of violations at two of its manufacturing plants, according to a Reuters Health report.

Although the number of annual new-drug approvals in the United States has steadily declined during the past ten years, pharmaceutical companies still prefer to introduce new products in the US first, according to a report published by the Tufts Center for the Study of Drug Development.

The US Food and Drug issued a draft guidance on Tuesday, Nov. 18, titled Process Validation: General Principles and Practices for comment. The guidance is meant to serve as a revision to the 1987 Guideline on General Principles of Process Validation.

Also, BASi opens European office in Warwickshire, UK; Acusphere's Howard Bernstein Resigns; More...

US marshals seized 11 lots of heparin from Celsus Laboratories (Cincinnati, OH) at the request of the US Food and Drug Administration.

Novo Nordisk will invest nearly $400 million to build a new insulin plant in Tianjin, China.

Also, Patheon opens new European headquarters, Cynvec appoints Frank D. Stonebanks president and CEO, more...

PAT may reduce costs by helping companies control process variability, improve yields, reduce waste, and produce high-quality therapies consistently. Companies that have not yet embraced PAT may find its potential to reduce expenses a compelling argument in its favor during this time of financial difficulty.

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the November 2008 edition from ResistoPure and Millipore.

Until recently, automated inspection of solid-dose pharmaceuticals was crude, expensive, slow, and difficult to change over. But technological advances have ushered in a new class of vision-inspection systems that is more effective and more commercially viable than older systems.

Also, Sartorius Stedim Biotech GmbH to acquire Wave Biotech; AstraZeneca's John Patterson to retire; more...

Arguments in the Supreme Court case Wyeth v. Levine have concluded, leaving both sides to wait possibly until early 2009 for a decision in a preemption case involving the misadministration of Wyeth's "Phenergan."

The US Food and Drug Administration sent Warning Letters to Bayer HealthCare (Morristown, NJ) about the company's "Bayer Women?s Low Dose Aspirin + Calcium" and "Bayer Aspirin with Heart Advantage" over-the-counter (OTC) products.

The US Food and Drug Administration has issued a final rule requiring the addition of a statement and toll-free number to the labeling of certain human drug products.

Policymakers weigh new rules to ensure the safety and quality of drugs made with tiny particles.

A well-balanced guide to industrial bioseparations provides valuable information.

Brief pharmaceutical news items for November 2008.

Data capture needs to be fast and reliable...so which automatic identification technology is best?

The Indian government may soon monopolize its pharmaceutical industry to cut costs and improve healthcare, but the move is sounding off alarm bells with the companies whose drug products are under review.

The US Food and Drug Administration seeks to understand nanotechnology better and exercise appropriate oversight over products that incorporate it.

The authors evaluate the effect of various mill types on particle-size distribution, flowability, tabletability, and compactibility.

The authors examine the effectiveness of an excipient comprised of mannitol, polyvinyl acetate, and crospovidone using model actives loperamide hydrogen chloride and caffeine.

Pharma companies could benefit from the lessons learned in this fall's financial crisis.

Editors' Picks of Pharmaceutical Science & Technology Innovations

Production problems come in all shapes, sizes, and ... species.

Pharmaceutical Technology will feature video coverage of AAPS this month.

Molecules called "chaperones" facilitate correct protein folding.

The authors explain the factors that can cause a failure in a bubble-point integrity test and what to consider when a product-specific bubble point must be defined.

The author discusses the key issues to consider when using isolators such as containment, protection of personnel, the efficiency of biodecontamination cycles, sterility assurance levels, barriers and their integrity, and environmental impact.

The authors describe a novel approach for the integrity testing of large sterile filter systems such as multiround housings and describe a multipoint diffusion test capable of detecting minor failures.