Keyword: Alkem Laboratories
The FDA has approved a new generic of Diovan from India's Alkem to help relieve a shortage of the ubiquitous high blood pressure treatment.
After a year of nothing but bad news about FDA citations of its plants, India’s Alkem Laboratories has announced something positive.
FDA inspectors began rolling through the plants of India’s Alkem Laboratories last year and have now found issues with a third Alkem facility.
India’s Alkem Laboratories, already dealing with concerns raised by EU regulators over one plant, now says the FDA has issued more than a dozen observations at one of its other key facilities.
A faked electrocardiogram lies at the heart of an EMA probe on drug testing by India's Alkem Laboratories.