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Siva Vaithiyalingam PhD Vice President, Regulatory Affairs Cipla LTD

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Page 1: Siva Vaithiyalingam PhD Vice President, Regulatory … Vaithiyalingam, PhD, Cipla LTD –Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017 Proteins

Siva Vaithiyalingam PhD Vice President, Regulatory Affairs

Cipla LTD

Page 2: Siva Vaithiyalingam PhD Vice President, Regulatory … Vaithiyalingam, PhD, Cipla LTD –Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017 Proteins

Siva Vaithiyalingam, PhD, Cipla LTD – Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017

Proteins Peptides Opioids and Abuse Deterrent (AD):

Page 3: Siva Vaithiyalingam PhD Vice President, Regulatory … Vaithiyalingam, PhD, Cipla LTD –Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017 Proteins

Siva Vaithiyalingam, PhD, Cipla LTD – Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017

Proteins Peptides Opioids and Abuse Deterrent (AD):

Page 4: Siva Vaithiyalingam PhD Vice President, Regulatory … Vaithiyalingam, PhD, Cipla LTD –Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017 Proteins

Siva Vaithiyalingam, PhD, Cipla LTD – Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017

Partial AUC for Establishing Bio-Equivalence

Page 5: Siva Vaithiyalingam PhD Vice President, Regulatory … Vaithiyalingam, PhD, Cipla LTD –Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017 Proteins

Siva Vaithiyalingam, PhD, Cipla LTD – Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017

BCS III Waiver:

Page 6: Siva Vaithiyalingam PhD Vice President, Regulatory … Vaithiyalingam, PhD, Cipla LTD –Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017 Proteins

Siva Vaithiyalingam, PhD, Cipla LTD – Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017

BCS III Waiver:

Page 7: Siva Vaithiyalingam PhD Vice President, Regulatory … Vaithiyalingam, PhD, Cipla LTD –Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017 Proteins

Siva Vaithiyalingam, PhD, Cipla LTD – Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017

NTI Drugs

Page 8: Siva Vaithiyalingam PhD Vice President, Regulatory … Vaithiyalingam, PhD, Cipla LTD –Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017 Proteins

Siva Vaithiyalingam, PhD, Cipla LTD – Confidential / GDUFA Amendments of 2012 Regulatory Science Initiatives May 3rd 2017

Thank You

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