FDA offers bioequivalance API guidance; U.S. gets BASF's API HQ; Daiichi Sankyo consolidates;

> The FDA has issued draft guidelines for dozen of APIs intended to provide insight for drugmakers designing bioequivalance studies. Guidelines

> BASF ($BASF) will move the world headquarters for its API and excipient operations, Pharma Ingredients & Services, to Florham Park, NJ, from Switzerland. Item

> Japanese drugmaker Daiichi Sankyo is consolidating two plants and its logistics operations to make them more efficient. Item

> Indian drugmaker Anil Bioplus says it will spend about $28 million to build a plant in Halol, India, where it will manufacture enzymes and bio-chemical products. Report

> Lonza will manufacture Mydicar, an enzyme replacement therapy, for trials for developer Celladon, with the potential for a supply agreement if the treatment is approved. Item

And Finally... Indian manufacturer Dishman Pharmaceuticals and Chemicals says it intends to launch 60 generic APIs over the next 24 months. Story

Suggested Articles

Neopharma, which has been buying and building plants for several years, is buying a sterile injectables plant and assets in Japan from India’s Lupin. 

Already knocked by the FDA four times this year, Dr. Reddy’s now has a fifth Form 483 to dwell on. This time it’s at a plant with a history of faults.

In a warning letter, the FDA details how a Chinese OTC drugmaker handed over documents faked just for the agency's inspection—and admitted it.