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Lyophilization and Protein Formulation
New Drug Applications (NDAs) - Parenteral
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FDA Applications - Protein Formulation
/New Drug Applications (NDAs) - Parenteral
Health Canada - SUBMISSIONS FOR GENERIC PARENTERAL DRUGS
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The general requirements for all categories are outlined below: GENERAL REQUIREMENTS (CATEGORY I, II, III AND IV) -A new drug submission (see Guidelines for Preparing and Filing New Drug Submissions
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http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/pol/gen_subm_...
New Drug Applications (NDAs) - Parenteral
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