business activities

research and development

Research and Development of Generic APIs

The research and development of generics begins with the selection of products launched 10 years ago. This is done by conducting extensive market and product research. The synthesis routes for the target substances are innumerable, and much hard work and time are needed to find the route for high yield production with a corresponding low cost . The development period for our generics can be shortened by our capable research staff and with our modern state-of-the art equipment.

Our small laboratory development batches can be scaled up to a commercial basis keeping in mind safety, cost, and operational practicality. We have expertise in refining and process control to meet GMP requirements, including the purification of impurities and scale up.

We obtained our first Drug Master File (DMF). from the United States Food and Drug Administration (FDA) in 1987 with a corresponding, initial export to the U.S. We now have four DMFs and have passed a number of FDA inspections.

Beyond generics, we manufacture innovators’ products (both APIs and formulations on a contract basis, leveraging our manufacturing technologies and the presence of our excellent quality control system.

We are pleased to assist you in manufacturing your innovative product.

Supply of Intermediates and Impurities

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