The FDA has cited an Aurobindo sterile manufacturing plant in India for not doing everything it can to prevent contamination, according to a new report.
India’s Wockhardt saw its losses widen last year as its burgeoning regulatory issues with the FDA continue to chainsaw away at its finances.
A recent report says that FDA inspections of Indian drugmakers tripled between 2010 and 2015, and that trend continues this year, with the latest to feel the…
The FDA, which banned APIs coming from a Divi’s plant in India, has followed that with a warning letter that savages the facility for a lack of data integrity.
The FDA posted a document outlining the issues that have undermined AstraZeneca's efforts to win approval for ZS-9.
The FDA’s decision to ban the products of a Chinese API maker has left the World Health Organization in the lurch trying to find another company to supply the…
India’s Indico Remedies has had a sterile injectables plant blasted in an FDA warning letter for its laissez-faire approach to dealing with consumer complaints.
The industry is asking the FDA to pause enactment of guidance that would require manufacturers to report their progress on meeting quality metrics.
The FDA has nailed India's Indoco with a warning letter for a sterile and solid dose plant in Goa because of its concerns over an injected drug.
For the second time in six weeks, Dr. Reddy’s has been rebuffed by the FDA for its efforts to deal with problems outlined in a warning letter two years ago.