About Us

Nivagen Pharma is a speciality pharmaceutical company established in 2009, engaged in development and marketing of generics & branded prescriptions drugs in US Markets. Forayed in to Inhouse Development of Sterile Injectables and 505(b)(2) products in 2018 by establishing a State-of-the art R&D facility in California.

Our vision is to deliver high quality products at affordable prices by leveraging global partnerships with the best FDA approved manufacturing facilities across the world.

History

Nivagen has aimed from a Sales & Distribution focused Virtual Company to a fully integrated specialty pharma company with inhouse R&D, Manufacturing and Marketing of Complex generics,505b(2) and FDA drug shortage products

2009 - 2010

Company incorporated
Started as a Virtual company with a focus on Sales Distribution of sustainable portfolio of generics in US Markets

2011 - 2013

Developed multiple sales channels through GPOs, Wholesalers & Pharmacies
Acquired Wholesaler licenses in all 50 States
Ventured into OSD ANDA development through partnerships

2014 - 2016

Partnerships with CROs and CDMOs globally for Development/ Co- development of ANDAs and in licensing ANDA

2017 - 2019

R&D Facility in CA for development of General Injectables & 505(b)(2) products
India Office with a team strength of 10 Employees for managing the Business Development, Tech Transfer, Regulatory, Logistics and Project Management

2020 - 2021

Portfolio of 25+ Injectables and 505(B)(2) under various stages of development
32+ ANDAs in Market

2022 - 2023

Initiation of Sterile Injectables focused Manufacturing facility in CA with capabilities to manufacture various dosage forms
5 Injectables ANDAs ready to launch in 2023
Acquisition of new 503(b) manufacturing facility in Los Angeles, CA