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.
USP Opens Door to Pending Monographs for Excipients
May 13th 2010Effective May 1, 2010, the US Pharmacopeia has revised its Pending Monographs Guideline to clarify that excipients are eligible for pending-monograph status and can ultimately be included in an official National Formulary (NF) monograph.
SOCMA Issues API Quality-Agreement Template
May 13th 2010In an effort to standardize quality agreements for active pharmaceutical ingredients in the drug industry, the Bulk Pharmaceuticals Task Force, an affiliate of the Society of Chemical Manufacturers and Affiliates, has developed a template to help manufacturers and customers comply with US regulatory requirements in a simplified manner.
Controlling the Release of Highly Dosed and Highly Soluble Drugs
May 1st 2010The authors formulated bupropion hydrochloride tablets with various grades of methacrylic copolymers and analyzed the properties of the resulting dosage forms. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."
Change is in the air for the European Clinical Trials Directive
May 1st 2010Though many advantages are associated with the European Clinical Trials Directive, complexities have emerged since its introduction in 2004. Since 2007, efforts have been made to raise the issues and address the negative impact of the Directive.