1422435-41-3 Dabigatran Carboxamide Ethyl Ester 98%

 We are manufacturers of bulk drugs (Active Pharmaceutical Ingredients) with a clear focus on generic drugs in the anti-epileptic segment. Since inception in 1977, the company has moved from strength to strength, first establishing a reliable manufacturing design and then on business development.

     Consistency of Quality and Reliability in Delivery have been the core principles adopted in every operation of the company. These are a result of strict adherence to quality control, pollution control and manufacturing process standards.

Current Initiatives

1.cGMP Compliance

      With the revised Schedule M guidelines released by the Food & Drug Administration of India, a project to ensure compliance with them is currently under way. This mega project has been undertaken to ensure that every precaution and guideline for quality control is maintained and complied with.

The company has undertaken a comprehensive overhaul of the manufacturing plant with focus on:

       A.Warehousing and Storage Areas

       B.Plant design to conform to revised norms

       C.Air and Water Handling Systems

       D.Pollution and Effluent Control

       E.Documentation on Product Analysis to evolve the final Drug Master File , with stability studies, impurity profiling and residual solvent analysis.