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Drugmakers making major alterations to their products will require a different EU number if they change the specifications or the amount of units contained in a pack, under updated guidelines in Europe. Read More
Australia’s Therapeutic Goods Administration is turning to the European Union for guidance as it seeks to adopt 10 guidelines — four new and six replacements — to improve the nation’s drug system. Read More
Sun Pharmaceuticals is recalling 5,322 bottles of Ketorolac tromethamine ophthalmic solution in the U.S. and Puerto Rico for failing to meet specifications. Read More
The FDA has halted imports of drugs from two Ipca manufacturing facilities in India due to good manufacturing practice violations, marking the second and third FDA-imposed import alerts against the drugmaker this year. Read More
An FDA request for feedback on its drug compounding regulations is likely to generate questions and comments on GMPs, office-use compounding of nonsterile drugs and more, experts say. Read More
The FDA has warned a French drugmaker for data integrity issues related to the production of active pharmaceutical ingredients at its Thailand manufacturing plant. Read More
UK inspectors cited 19 companies for critical pharmacovigilance weaknesses in the fiscal year ending March 31, 2014, roughly even with the 18 citations in the previous year. Read More
Making good on its promise to encourage use of new and better technologies in drug manufacturing, the FDA has issued its first guidance for drugmakers using near infrared technology to measure product quality. Read More
Hospira will have to delay the opening of its new Visakhapatnam, India, plant because of persistent problems turned up during FDA inspections of the facility. Read More
A slew of observations related to cleanliness and sterility at Patheon Manufacturing Services’ Greenville, N.C., facility have resulted in a Form 483. Read More
The FDA has warned a Kansas compounder for multiple GMP violations, including poor sterile drug manufacturing practices and using ingredients that aren’t FDA-approved. Read More