Our current oral solid dosage form development plan includes 26 products (IR & CR) under development. The total brand sales in 2007 were nearly $4.3 Billion. Of the current 26 products, 3 are at the ANDA submission stage, 4 projects at the pivotal biostudy stage, 4 projects under the pilot biostudy stage, 2 projects at the ANDA batch manufacturing stage and 13 projects are under development. The development & manufacturing process is at the facility of USV Ltd., India which has been inspected and approved by the US FDA.
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Initiation of parenteral product development has begun at the facility and the first ANDA submission is expected to be filed by 2009.
Indicus Pharma has successfully engaged in co-development partnerships with several pharmaceutical companies on various products.
To date, Indicus Pharma has filed a total of 7 ANDA submissions of which 2 have received product approvals. Our goal is to submit 7-8 ANDA submissions per year. |
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Welcome To Indicus Pharma LLC. |
Indicus Pharma LLC is a US based pharmaceutical company, registered in the State of Delaware and headquartered in Raleigh, North Carolina. The company is focused on the development and manufacture of niche generic formulations for the US market.
Niche generics are technically challenging products with limited competition in the US Generic market and generally fetch greater market share with higher returns. These products are developed using specialized technologies that can be patented.
Indicus Pharma LLC is incorporated as a strategic alliance between USV Limited, India and Dr. Nitin Sheth (President & CEO: Indicus Pharma LLC) with the goal of capitalizing on the opportunity in the US generic industry.
Our strong marketing alliance and flexible business arrangement policies help us to create long-term, reliable partners. With a full development of products suggested by our clients, we also undertake new molecule development as well as engage in co-development practices.
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