Generic formulation development, manufacturing and marketing

We have a cGMP complaint R&D facility for formulation manufacturing, testing and development. We also have the capability to develop formulations along with requisite BA/BE studies, regulatory services and filing of the ANDAs. We also contract manufacture the developed formulations for US and ROW markets. Our present reach of marketing formulations expands across Singapore, Malaysia and South Africa and various other countries through partnerships. We have already achieved 12% market share in majority of the launched products and more than 35% to 50% market share in other niche products. The generic formulations manufactured by Indian manufacturers are marketed by THINQ/RISING under exclusive marketing agreements in the US market. Currently we have more than a dozen prescription products being sold under our label in the U.S. market and more than 30 products under development.

APIS, CRAMS and Advanced Intermediates Development and Marketing

With extensive knowledge of pharmaceutical ingredients over the past 25 years we can say with confidence that we have the ability to develop complex chemistry. In the past, we have had Mr. Robert Grubbs, a renowned Nobel Laureate, on our Technical Board.

We have worked with almost all MNCs, including Japanese companies developing CRAMs and intermediates with complicated technology.

Our R&D Centre is over 300 Sq. Mts. and is now being expanded by another 400 Sq. Mts. We have efficiently handled the development of products in a confidential and exclusive basis. We have the capacity to take up 10-12 projects simultaneously.

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Clinical studies and Clinical data management

Established in 2003, our CRO business has gained primary importance in the services that we provide. We were the first Indian CRO to produce and implement Oracle Clinical, thereby enabling improved operational efficiency and productivity even in complex trial design scenarios. Our top priority is to maintain consistent data quality that includes functionality across multiple areas: Trial Budgeting, Regulatory Affairs, Data Management, Pharmacovigilance in collaboration with our associates, Medical Writing, Clinical Operations and Statistical Analysis.

Regulatory Services

We have the expertise to provide expert clinical and regulatory support through all phases of global drug development to commercialization, from BA/BE Analysis to Quality cGMP compliance. We prepare all regulatory documentation including filing of DMFs, ANDAs and maintaining post approval change management. Our proficiency in organizing quality dossiers ensures timely approvals. We have the bandwidth to support clinic and regulatory activities across USA, EU, Asia Pacific and Latin America.