Topic: 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.
McCallum was hit with a warning letter from the FDA for testing issues with its products and failing to keep appropriate records.
The FDA issued a warning letter to Hong Kong-based over-the-counter drugmaker Luen Wah Medicine, citing the company for not testing the identity and strength of each active ingredient in its products.
The FDA hit New Jersey-based CMO Tris Pharma with a warning letter, citing significant violations.