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The FDA has banned imports from active pharmaceutical ingredient maker Canton Laboratories, the fourth Indian drugmaker in a month to be put on import alert for poor quality. Read More
The FDA has banned Canadian generics maker Apotex from importing drugs to the U.S. made at its Bangalore, India, site, pending quality upgrades. Read More
Manufacturers estimate that a medium-sized drugmaker would have to pay roughly $36 million to implement a serialization and traceability system required under the new federal track-and-trace law. Read More
Indian generics maker Sun Pharmaceutical said last week that it will close its Detroit, Mich., plant this summer as part of its consolidation of U.S. manufacturing operations. Read More
AstraZeneca (AZ) rebuffed a new $106 billion merger bid from Pfizer on Friday, saying that even after Pfizer added $6 billion to the offer it still “substantially” undervalues the company. Read More
Pfizer is receiving blowback from UK scientists, lawmakers and a top company executive for its proposed multi-billion dollar merger with London-based AstraZeneca (AZ). Read More
Drugmakers should implement and maintain security procedures for electronic safety-and-acknowledgement messages over the internet, according to a European draft guidance that provides technical requirements around online data protection. Read More
Manufacturers should include effective evaluation and verification studies in their process validation documentation when obtaining biotechnology-derived proteins in the EU, according to a new guidance from the European Medicines Agency (EMA). Read More
One of the leading manufacturers of painkillers is calling for leniency from the Drug Enforcement Administration (DEA) if it decides to adopt new restrictions for hydrocodone combination products. Read More