Generic Drug Process Research Service

The availability and utilization of generic pharmaceuticals as an alternative to name-brand medications significantly affect how much money customers can save on healthcare. The establishment of a commercial manufacturing process that reliably generates APIs of the desired quality is the aim of the development of API manufacturing processes. Our company provides customers with professional development, optimization, and manufacturing services for the API manufacturing process of generic drugs.

Service Overview

Our company's primary services for API process research for generic drugs include, but are not limited to, the following.

• Design of synthetic routes with intellectual property rights and cost advantages.
• API synthesis route screening.
• API crystal confirmation.
• API process optimization.
• API quality studies.
• Small batches, pilot tests, and at least three batches of cGMP process validation.
• API stability testing.
• API analytical method development and validation.

Research Capabilities

Our company's generic API development program includes the following phases.

Product Development: research, project evaluation and consulting, etc.

Reference Formulation Research: reference formulation screening, filing and purchase, etc.

Pharmacological Studies:

• Study of key quality attributes of APIs.
• Quality comparison with the reference formulation.
• Comparative research work on impurity profiles of API and reference formulations.
• Quality studies for the development, optimization, change and process validation of the synthesis process of APIs.
• Prescription variables and formulation process parameters variables research study to ensure the quality consistency work of generic drugs and reference formulations.
• Stability study and method validation.
• Technology transfer, etc.

Our company builds a database of key process parameters by continuously optimizing the process to obtain a mature and easy-to-industrialize route. In order for the prepared APIs to satisfy the requirements of generic formulations and thus reach a given scale of industrial production, we establish complete impurity profiles of starting materials, intermediates, and APIs based on the features of the process routes.

If you want to know more about service details, please feel free to contact us.

It should be noted that our service is only used for research, not for clinical use.