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Nicox, an international ophthalmic R&D company, announced it received a complete response letter related to its NDA for its cetirizine eye drop formulation AC-170. Read More
Syntese has received a Form 483 after an inspection revealed sanitation, quality and laboratory control issues at the Denmark-based API maker. Read More
UK-based Wallace Cameron International has not fulfilled its registration obligations to continue manufacturing and exporting drugs to the United States, the FDA said. Read More
A pharmaceutical company in Beijing has received a warning letter from the FDA after barring investigators from the facility as well as falsifying and back-dating records. Read More
The French National Agency for Medicines and Health Products Safety (ANSM) released a statement alleging serious violations of good manufacturing practices at Nandu Chemicals Industries, an India-based API maker. Read More
After the FDA clamped down on its facilities most of the year, Lupin has received clearance from the agency to produce drugs again at its site in Goa, India. Read More