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.
Sandoz Introduces New Follow-On Version of Recombinant Biotechnology Drug
March 20th 2008Sandoz introduced its "Omnitrope Pen 5" with liquid cartridge in the United States. The product was approved by the US Food and Drug Administration and is a new form of the first follow-on version of a recombinant biotechnology drug.
USP and Chinese Pharmacopoeia Commission Sign Memorandum of Understanding
March 13th 2008The US Pharmacopeial Convention (USP) signed a Memorandum of Understanding (MOU) with the Chinese Pharmacopoeia Commission (ChP) designed to strengthen the quality of medicine and foods in the United States and China.
Congressional Committee Passes IST Measure
March 13th 2008The US House of Representatives Committee on Homeland Security approved legislation last week that mandates inherently safer technologies (IST) as part of chemical-site security standards, a move that was opposed by the Synthetic Organic Chemical Manufacturers Association.
IST Measures Raise Concern for the Pharma Supply Chain
March 5th 2008Draft federal legislation that would require high-risk chemical facilities to use inherently safer technology for reducing their risk may present potential problems for custom and batch manufacturers supplying the pharmaceutical industry.
Product Annual/Quality Review: US–EU Comparative Analysis and Interpretations
March 2nd 2008There are significant differences between the United States and European Union requirements for the annual review of records related to the manufacturing and control for pharmaceutical products and active pharmaceutical ingredients.
Vintage Pharmaceuticals Receives Warning Letter
February 21st 2008The US Food and Drug Administration has issued generics manufacturer Vintage Pharmaceuticals a warning letter stemming from July through August 2007 that found observations pertaining to microbial contamination and failures in testing and documentation procedures.
Baxter Voluntarily Recalls Heparin Lots
February 14th 2008Baxter Healthcare Corporation is providing an update to its January 2008 heparin sodium injection 1000 units/mL 10 and 30mL multi-dose vial voluntary recall of nine lots, which the company initiated as a precautionary measure due to an increase in reports of adverse reactions that may be associated with the drug.