Informes

Diciembre 2008

• Validation of Technique: Benzoate and Impurities Content
  
• Report on the evaluation of module 3 presented for the authorization to market 75 mg Clopidogrel coated tablets

Noviembre 2008

• Report on the transfer of analytical method for the determination of related substances in raw materials between two laboratories
  
• Report on the transfer of analytical method for the assessment of raw material between two laboratories.
  
• Report on the transfer of analytical method for the assessment of content between two laboratories.
  
• Report on the transfer of analytical method for the determination of residual solvents (Method I and Method II) between two laboratories.

Septiembre 2008

• Validation Protocol: Rivastigmine
• Specification and Control Methods: Rivastigmine Oral Solution
  
• Validation of HPLC Analytical Technique for Rivastigmine and Sodium Benzoate
  
• Quality Control: Sodium Benzoate Excipients
  
• Quality Control: Rivastigmine Hydrogen Tartrate Raw Material

Junio 2008

• General Clinical Overview: Letrozole cinfa 2.5 mg film-coated tablets EFG
  
• General Non-Clinical Overview: Letrozole cinfa 2.5 mg film-coated tablets EFG

Mayo 2008

• Stability tests in the use of rivastigmine 2 mg/ml oral solution
  
• Use of Butylhydroxyanisol (BHA) in Coated Atorvastatin Cinfa
  
• Development of the rivastigmine 2mg/ml oral solution product

Abril 2008

• Technical data: Atorvastatin Cinfa
  
• Patent Report: Lipstatin