Review

• Covering Global Pharmaceutical Regulations in a Quality System

  Siegfried Schmitt

  Pages 1-4

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• A review on ANDA submission requirements for Generic drugs: “Paragraph IV certification” as per FDA CDER guidelines

  Saffiya Khatun M, Jyothshna Devi Katamreddy, Jayachandra Reddy P

  Pages 5-12

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• Registration of Drug Product dossier application as per EU Guidelines

  Bhavya Kondepati, Jyothshna Devi Katamreddy, Jayachandra reddy P

  Pages 13-23

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• Saxagliptin and Dapagliflozin for type 2 Diabetes mellitus: A Review

  Deepshi Ranjan, Akanksha Sharma, Ramesh Babu Bodla

  Pages 24-30

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• Drug approval process in US, Europe and India and its regulatory requirements: A Review

  Krishnasis Chakraborty, Kavita Yadav

  Pages 31-39

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• Regulatory overview of biosimilars in Europe

  Jyothi Sri Durga Vanacharla, Shailaja Pashikanti, Sowmya A. N. V. L

  Pages 40-44

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• Study the effects of Nipah Virus – A Review

  Dhiraj Kumar Singh, Rakhi Ahuja, Nagendra Kumar Singh

  Pages 45-52

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