Topic: FDA warning letter
Celltrion says its biosimilars for Herceptin and Rituxan could be approved this year after it made plant improvements to resolve and FDA warning letter.
FDA clears Sun Pharma's key Halol plant, Eisai builds a new drug discovery center for Alzheimer's, opposition to the Takeda-Shire deal gains support.
The FDA issued Taiwan Biotech a warning letter, citing a number of issues with the company’s quality-control unit.
After more than two years of intense effort, Sun Pharma has returned its key plant to the good graces of the FDA.
The FDA issued a warning letter to Korean contract drug manufacturer Kolmar Korea, citing significant GMP issues.
Turnaround efforts at IDT Australia now include an FDA warning letter.
Celltrion says it has made enough progress fixing issues at its plant cited by the FDA and has resubmitted its application for its version of Rituxan.
The FDA slapped Chinese API maker with a warning letter citing quality-control and data-integrity issues.
The FDA hit Ei with a warning letter outlining poor manufacturing procedures at the company’s facility in Kannapolis, North Carolina.
Takeda plans major cuts after $62 billion Shire buyout; Ascletis files for HK IPO under new listing rules; AZ hands Seroquel rights to Luye Pharma.