The U.S. FDA has flagged another India production plant for violations, this time an Ipca Laboratories facility in central India, leaving the company only two U.S. FDA-approved plants producing exported generics.
The U.S. FDA has flagged another India production plant for violations, this time an Ipca Laboratories facility in central India, leaving the company only two U.S. FDA-approved plants producing exported generics. Ipca halted all shipments to the U.S. after the FDA said it found at least six violations, including data integrity. Ipca said it was complying with the agency's notice and would correct the problems within the next four months. (Click here for more
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Henlius is investigating the optimum dose for its PD-L1-targeting antibody-drug conjugate HLX43 to support potential first-line use, its CEO explains to Scrip.
Sun’s founder hands top job to company longtimer Kirti Ganorkar as the firm implements a “structured and forward-looking” succession plan, while Richard Ascroft will lead the Indian drugmaker’s North America business.
After in-licensing a cardiovascular candidate last year, AstraZeneca has signed a strategic drug discovery alliance, which could generate billions of dollars in payments to the Chinese firm.
