March 14th 2025
The certification allows Benuvia to produce pharmaceutical products for companies, either local to Brazil or international, that may be looking for compliant and high-quality production capabilities in the Brazilian pharmaceutical market.
EMA Releases Revised Computerized Systems Annex to GMP Guide
February 3rd 2011The European Medicines Agency has released a new Annex 11-Computerized Systems to its GMP Guide Chapter 4 on Documentation to account for the increased use of and complexity of computerized systems in the drug-manufacturing community.
Senators Reintroduce Bill to Curb Pay-for-Delay Settlements
February 3rd 2011Last Friday, Senators Herb Kohl (D-WI) and Chuck Grassley (R-IA) reintroduced their "Preserve Access to Affordable Generics Act," which would presume that pay-for-delay settlements were illegal and give the Federal Trade Commission (FTC) the power to block them.
Practical Steps To Prevent Counterfeiting
January 14th 2011With counterfeit medicines increasingly appearing in legitimate supply chains and even in the clinical stages of product development, a recent white paper has outlined practical steps that may help companies address the issue of counterfeits and diverted products.