News of Note—FDA gets specific on data integrity rules; Lupin, Dishman tagged with 483s

newspapers
(Pixabay)

Here is some news of note for the week:

> The FDA has posted information about its now-completed "Data Integrity and Compliance With Drug CGMP" guidance. Q&A

> CDMO Cambrex will invest $1 million at its High Point, North Carolina, site to fit out a 1,300-square-foot analytical laboratory space. Release

Free Daily Newsletter

Like this story? Subscribe to FiercePharma!

Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FiercePharma as their must-read source for the latest news, analysis and data on drugs and the companies that make them. Sign up today to get pharma news and updates delivered to your inbox and read on the go.

> India’s Lupin has downplayed the 22 observations it got in an FDA inspection of its Mandideep cardiovascular “Pril” facility, its cephalosporin API facility and cephalosporin solid oral facility. Release

> India’s Dishman has received a Form 483 in which it got two observations for a plant in Gujarat including one in which it was found to be blending batches that were out of spec for an impurity with batches that met specs. 483

Suggested Articles

The FDA is allowing some drugmakers to exceed the level of risk from a probable cancer-causing impurity in losartan for six months.

CDMOs Cambrex and Ajinomoto Bio-Pharma Services upgraded manufacturing plants, Takeda scored an albumin approval via its Shire deal, and more.

The FDA hit United Exchange Corp. with a warning letter, citing the company for a number of “significant” violations with its quality-control systems.