Nitin Gaikwad | Senior General Manager Of Regulatory Affairs
Lupin Pharmaceuticals | India

Nitin Gaikwad, Senior General Manager Of Regulatory Affairs, Lupin Pharmaceuticals

Nitin Gaikwad graduated with Master of Science
in Biochemistry from the University of Pune and he has over 28 years
pharmaceutical industry experience of which over 20 years in the Regulatory
Affairs Department with Lupin Limited, Mumbai, India. Nitin has acted as
Pharmaceutical Quality Expert for more than 100 generic products for Europe, Australia and Canada
submissions. He has represented the company in many Scientific Advice meetings
with UKMHRA, TGA-Australia and Health Canada. He also represented the company
in multiple pharmaceutical plant GMP inspections by various Health Authorities
ex. UKMHRA, ANSM France, Berlin-Germany GMP inspectorate, TGA Australia, Turkey Ministry of
Health, Uganda National Drug Authority. He is a member of the Parenteral Drug
Association (PDA) in USA, ARCS-Australia and Indian Pharmaceutical Association. Nitin has been chosen finalist at Global Generics and Biosimilar Awards, to be held in Frankfurt Germany on November 5, 2019 for 'Regulatory Achievement of the Year' category

Appearances:



Phar East 2020 Agenda Day One @ 17:20

Challenges and regulatory considerations in development of complex generics

last published: 10/Jun/20 01:56 GMT

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