Archive for June, 2007

Ampac Fine Chemicals Automates Regulatory Compliance, Enables Improved Manufacturing Efficiency

Published by June 22nd, 2007 in FDA Compliance. 0 Comments

Ampac Fine Chemicals Automates Regulatory Compliance, Enables Improved Manufacturing Efficiency And Automates Core … (ChemicalOnline) Oracle recently announced that Sacramento, Calif.-based Ampac Fine Chemicals (AFC), a wholly-owned subsidiary of American Pacific Corporation that manufactures active pharmaceutical ingredients and registered intermediates, has deployed Oracle E-Business Suite financial, procurement and manufacturing capabilities to help facilitate regulatory compliance, […]

FDA Approvals - SmallCap Sentinel: Medical Milestones (PrimeNewswire via Yahoo! Finance) IRVINE, Calif.,

Published by June 22nd, 2007 in FDA Approvals. 0 Comments

SmallCap Sentinel: Medical Milestones (PrimeNewswire via Yahoo! Finance) IRVINE, Calif., June 21, 2007 — “In a market populated by bold optimism and bright-eyed business plans, few companies ascend to the lofty precipice of FDA submissions and approvals,” stated D.R.
Axcan Pharma Submits CMC Portion of its New Drug Application for ULTRASE and is Granted Fast […]

FDA Approvals - Ranbaxy Receives Tentative Approval to Manufacture and Market Amlodipine Besylate

Published by June 21st, 2007 in FDA Approvals. 0 Comments

Ranbaxy Receives Tentative Approval to Manufacture and Market Amlodipine Besylate Tablets (RedNova) PRINCETON, N.J., June 20 /PRNewswire/ — Ranbaxy Pharmaceuticals Inc. (RPI), a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced today that RLL has received tentative approval from the U.S.
Inovio Biomedical’s Selective Electrochemical Tumor Ablation Therapy Shows Safety, Tolerability, and Significant … (Business […]

FDA Approvals - Wyeth’s ‘A3/Prime-2′ ratings for possible upgrade - Moody’s (Sharewatch) LONDON

Published by June 5th, 2007 in FDA Approvals. 0 Comments

Wyeth’s ‘A3/Prime-2′ ratings for possible upgrade - Moody’s (Sharewatch) LONDON (Thomson Financial) - Moody’s Investors Service said it has placed the ratings of Wyeth, rated ‘A3 long term, Prime-2 short term’ under review for possible upgrade, following two new FDA approvals and the recent resolution of FDA manufacturing compliance issues.
FDA slaps MedImmune with FluMist warning […]