Topic: FDA warning letter
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.
Celltrion remains optimistic it will get U.S. approval for its two biosimilar drugs, Rituxan and Herceptin, by the end of the year.
The FDA issued a warning letter to Labocont Industrial following an inspection last year and cited the company for failing to make fixes.