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Handbook of Pharmaceutical Manufacturing Formulations: Sterile Products
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Key Features
  • formulations of sterile dosage forms, regulatory filing requirements of sterile preparations, and cG
  • specifications of a manufacturing facility to manufacture compliant sterile products
  • NDA or aNDA filing requirements of sterile products
  • an alphabetical presentation of formulations of pharmaceutical products based on their generic names
Description

No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing sterile products has evolved into a very sophisticated industry.

More Details About Handbook of Pharmaceutical Manufacturing Formulations: Sterile Products
General Information
Author(s)Niazi
PublisherInforma Healthcare
Edition2
ISBN9781420081305
Pages464
BindingHardcover
LanguageEnglish
Publish YearJanuary 2009
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