Indicus Pharma
Indicus Pharma, established in 2005, is a Delaware-registered company with a marketing office in Durham, North Carolina. It focuses on developing and supplying niche generic formulations to the US market, collaborating with leading US pharmaceutical companies. The company markets products primarily developed and manufactured by USV Private Limited, India, and aims to be a leading player in select molecules, emphasizing innovation, specialized technologies, and global standards of quality. Indicus Pharma's mission is to be recognized as a reliable healthcare provider, offering superior value through innovation and focused efforts, while its vision is to attain leadership in all business units and be respected by stakeholders.
Industries
Nr. of Employees
small (1-50)
Indicus Pharma
2530 Meridian Parkway, Suite 300, Durham, NC 27713
Products
Niche Generic Formulations
Development and supply of technically challenging generic formulations with limited competition for the US market.
Immediate and Controlled Release Products
Development of solid oral immediate and controlled release pharmaceutical products.
Poorly Soluble Drugs
Development of drugs with enhanced solubility and bioavailability.
ANDA Submissions
Submission of Abbreviated New Drug Applications (ANDAs) to the US FDA, aiming for 2-3 submissions annually.
Adverse Event Reporting
Service for reporting side effects or adverse reactions associated with Indicus Pharma's products.
Niche Generic Formulations
Development and supply of technically challenging generic formulations with limited competition for the US market.
Immediate and Controlled Release Products
Development of solid oral immediate and controlled release pharmaceutical products.
Poorly Soluble Drugs
Development of drugs with enhanced solubility and bioavailability.
ANDA Submissions
Submission of Abbreviated New Drug Applications (ANDAs) to the US FDA, aiming for 2-3 submissions annually.
Adverse Event Reporting
Service for reporting side effects or adverse reactions associated with Indicus Pharma's products.
Services
Development and supply of technically specialized generic formulations for the US market, including formulation design and transfer for commercial manufacture.
Partnership-based co-development, licensing and commercialization services with flexible commercial models for US-focused product launches.
Preparation and submission support for ANDA dossiers and coordination of regulatory interactions to obtain US approvals.
Processes for receipt and handling of adverse event reports and product complaints.
Development and supply of technically specialized generic formulations for the US market, including formulation design and transfer for commercial manufacture.
Partnership-based co-development, licensing and commercialization services with flexible commercial models for US-focused product launches.
Preparation and submission support for ANDA dossiers and coordination of regulatory interactions to obtain US approvals.
Processes for receipt and handling of adverse event reports and product complaints.
Expertise Areas
- Niche generic drug development
- Formulation development (immediate and controlled release)
- Solubility and bioavailability enhancement
- Sterile product development
Key Technologies
- Controlled-release formulation techniques
- Solubility/bioavailability enhancement technologies
- Sterile manufacturing processes
- cGMP manufacturing systems
News & Updates
Indicus Pharma received its first US FDA product approval in 2007, marking a significant milestone in its development.
The company has a portfolio of 49 applications submitted, with 32 approvals from the US FDA by 2023, and continues to develop 5 to 10 products with partners.
Successful FDA inspection of manufacturing facility in 2007 with no 483 observations.
Indicus Pharma received its first US FDA product approval in 2007, marking a significant milestone in its development.
The company has a portfolio of 49 applications submitted, with 32 approvals from the US FDA by 2023, and continues to develop 5 to 10 products with partners.
Successful FDA inspection of manufacturing facility in 2007 with no 483 observations.