Articles by Chitra Sethi - BioPharm International

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Articles by Chitra Sethi

Celgene to Acquire Abraxis for $2.9 Billion

Jun 30, 2010

Celgene to Acquire Abraxis

Vetter Aims to Optimize Logistics with a New Facility in Ravensburg

Jun 18, 2010

Vetter held a groundbreaking ceremony for its new facility in Ravensburg.

Steven Burrill Predicts Biotech's Future in his 24th Annual Report

May 18, 2010

G. Steven Burrill released his 24th annual report on the state of the biotech industry at the BIO International Convention held in Chicago this month. Biotech 2010 -Life Sciences: Adapting for Success provides insight into biotech' s changing environment and how the industry will need to adapt to it.

Genzyme Expects $175 Million Fine

Apr 22, 2010

The biopharmaceutical company Genzyme Corporation (Cambridge, MA), is expected to be fined $175 million by the US FDA as part of the agency?s enforcement action to ensure that products manufactured at Genzyme?s Allston, MA, plant are made in compliance with GMP regulations.

Genzyme to Exit Fill-Finish Operations at Allston Landing Plant

Apr 5, 2010

The biopharmaceutical company Genzyme Corporation (Cambridge, MA), which suffered from a series of manufacturing problems including viral contamination at its Allston Landing plant in June 2009, has announced that it will phase out its fill-finish operations from the plant gradually.

PDA's Practical Guidance for Development and Qualification of Analytical Methods

Apr 1, 2010

A critical GMP requirement for drug manufacturers is to validate analytical test methods to ensure that they are suitable for their intended uses. There are published guidelines available that the industry can follow for validation but there are none for qualification, which is a key step in the validation process.

AstraZeneca Cuts 500 Jobs at US Headquarters

Mar 3, 2010

AstraZeneca will cut 500 research and development positions at its US headquarters in Fairfax, DE.

Merck KGaA to Buy Millipore for $7.2 Billion

Mar 1, 2010

German pharmaceutical and chemicals company Merck KGaA will buy US biotech equipment-maker Millipore for $7.2 billion.

Lilly Receives FDA Warning Letter

Feb 25, 2010

Eli Lilly & Company received a warning letter from the US Food and Drug Administration, citing significant deviations from current good manufacturing practices (cGMP) in the manufacture of active pharmaceutical ingredients (APIs) at its facility in Carolina, Puerto Rico.

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