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.
GMPs for Method Validation in Early Development: An Industry Perspective (Part II)
August 1st 2012The authors, part of the International Consortium on Innovation and Quality in Pharmaceutical Development (IQ Consortium), explore and define common industry approaches and practices when applying GMPs in early development.
Congress Passes Generic Drug Act
July 10th 2012On July 9, 2012, Congress passed the Generic Drug User Fee Act in an effort to expedite the process of bringing generic drugs to market. The Act authorizes the collection of user fees from generic-drug manufacturing companies for the first time in the industry's history.
ISPE Issues Guidance for Packaging, Labeling, and Warehousing Facilities
July 9th 2012ISPE has issued a guidance that is intended to help companies meet cGMP requirements for packaging, labeling, and warehousing facilities and avoid problems such as product adulteration, product mix-up, label mix-up, and misbranding.
FDA Issues Draft Guidance on OTC Products that Contain Acetaminophen
July 3rd 2012FDA has issued a draft guidance on the labeling of OTC products that contain acetaminophen. The draft guidance would give manufacturers an alternative option to properly clarify the risk of liver damage in OTC acetaminophen-containing products.
GMPs for Method Validation in Early Development: An Industry Perspective (Part II)
IQ Consortium representatives explore industry approaches for applying GMPs in early development.
EMA Makes Orphan Drug Recommendations
June 19th 2012The European Medicines Agency's Committee for Orphan Medicinal Products made recommendations for nine orphan drug designations during its June 2012 meeting. Included in COMP's recommendations were four designation applications for rare forms of lipodystrophy.