EMA wants comment on rule to identify API imports; FDA warns German devicemaker;

> The European Medicines Agency is giving drug manufacturers until June 1 to comment on its draft guidance for written confirmation of API imports from outside Europe, which it is introducing to protect against counterfeit drugs. Item

> The FDA has issued a warning letter to German device maker I.E.M. for an array of problems at its plant in Stolberg. Story

> The United States Pharmacopoeia (USP) will work with the South Korea Food and Drug Administration (KFDA) on quality standards for drug manufacturing. Item

> Major pharmaceutical manufacturers in Jammu, India, are asking the government to add infrastructure and educational opportunities in the area to help companies better compete in the world market. Story


Suggested Articles

Hikma says it has picked up some pipeline products and nasal and sublingual spray equipment from Insys Therapeutics' bankruptcy.

WuXi Biologics expects to have a plant in Europe complete in 2021 as a capacity race plays out among Asia’s rapidly growing biologics CDMOs.

After five years of struggles, Sun Pharmaceutical has put the problems at its key plant in Halol, India behind it.