Nitin Gawade

Sr. Manager Regulatory Affairs - API / CMC Regulatory expert. Indoco Remedies Ltd. R&D centre Navi Mumbai

Role: Sr Manager Regulatory Affairs - Api at Indoco Remedies Ltd
Location: Mumbai, MH, IN
LinkedIn followers: 500 followers

Manufacturing & ProductionView LinkedIn profile

About Nitin Gawade

Result driven regulatory affairs professional with demonstrated history of working in…

Experience

Sr Manager Regulatory Affairs - Api
Indoco Remedies Ltd
Mar 2017 — Present · Mumbai, IN
Responsible for smooth functioning of API regulatory submissions, life cycle management and customer support. Global API Regulatory submissions

Education

National institute of management
Master of Business Administration - MBA
Msc. Organic Chemistry from Savitribai Phule Pune University
Msc
2006 — 2006

Skills

Regulatory Affairs

Contact information

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Work email
•••••@indoco.com
Personal email
•••••@•••••.com
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Current company

Indoco Remedies Ltd

Pharmaceutical Manufacturing · 5.2K employees · Founded 1947 · Mumbai, Maharashtra, India

Indoco is a fully integrated, research-oriented pharmaceutical company with a strong global presence. The Company’s turnover is US$ 175 million with a human capital of employees, including over 300 skilled scientists and Field. Indoco develops and manufactures a wide range of pharmaceutical products for the Indian and international markets. It generates more than 109 million prescriptions annually from over doctors belonging to various specialties. The Company’s R&D team develops non-infringing processes for APIs, formulations and various dosage forms like Immediate Release Tablets, Capsules, Multi-Unit Pellet Systems (MUPS), PDDS, ER Tablets and nano suspensions, as well as a range of injectable solutions, suspensions and depot based long-acting injectables. Indoco has 11 domestic marketing divisions with a strong brand portfolio in various therapeutic segments, including Stomatologicals, Gastro-Intestinal, Respiratory, Anti-Infectives, Vitamins/Minerals/Nutrients, Cold & Cough, Ophthalmics, Antifungal, Antidiabetic & Cardiovascular, Urology, and several others. Top Indoco brands include, Cyclopam, Febrex Plus, ATM, Rexidin M, Karvol Plus, Oxipod, Cital, Sensodent-K, Cital-Uti, Dropizin, Homide, Otorex, Dentogel, Oxipod CV, Turbocort, Febrex, Cloben G, Tuspel LS, Noxa, MCBM 69 etc. Indoco exports a variety of products to regulated and emerging markets, including the USA and EU. The Company has tie-ups with large generic companies and works in close coordination with its customers to leverage core competencies. Indoco’s branded formulations are promoted and distributed across India and in Emerging Markets of South East Asia, Africa, Latin America and CIS. IAS division is USFDA approved and based at Navi Mumbai. It serves customers for their analytical research needs, utilizing state-of-utilizing state-of-the-art instruments and infrastructure.

indoco.com

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About Nitin Gawade

Experience

Sr Manager Regulatory Affairs - Api

Education

National institute of management

Msc. Organic Chemistry from Savitribai Phule Pune University

Skills

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