Topic: FDA warning letter
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.
The FDA slapped a warning letter on an Indian drugmaker after first banning its products for failing some basic FDA manufacturing standards.
Yinghua Biochemical and Pharmaceutical Co. was issued a warning letter by the FDA for data integrity issues and problems with its quality unit.
Shire nixed Takeda's $60 billion-plus buyout offer, Hanmi ditched lung cancer hopeful olmutinib, Grail is looking for $1 billion before Hong Kong IPO.