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The EMA Management Board has advanced the development of a web portal that will provide free information on European medicines across the products’ lifecycle. Read More
The European Medicines Agency is investigating reports that India’s Wanbury Pharma, one of the largest exporters of the diabetes drug metformin, had more than half of its exports produced by an unlicensed supplier. Read More
The UK Court of Appeal affirmed an earlier ruling that invalidates Pfizer’s patent claims for Lyrica, saying generic versions will not lead to any infringement. 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
Sun Pharmaceuticals has initiated a recall of more than 30,000 bottles of bupropion hydrochloride extended-release tablets for the treatment of major depressive disorder and seasonal affective disorder. 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
The European Medicines Agency’s Committee for Medicinal Products for Human Use is recommending the approval of five new medicines and three generics to treat a range of illnesses from cancer to HIV. Read More