API Process Development

We are an ideal contract partner for your API Process Development

We are inspected and Health Department approved, and provides integrated process development, API manufacturing at a single location. We have all the expertise required for developing a process that is robust, transferable, and scalable to meet your requirements.

We bring 30 years of experience to every project and deliver fully integrated solutions with an emphasis on quality, speed, and flexibility.

Our Contract Services include:

Lead Identification

Synthetic Route Development

Feasibility Studies

Process Parameterization Optimization

Scale-up Troubleshooting

Engineering Batches

cGMP-API Manufacturing

Process Development & Manufacturing Services

01.
Optimization of existing synthetic routes
02.
Development of GMP friendly alternative synthetic routes
03.
Development of IP protected synthetic routes
04.
Statistical Design of Experiments (DoE) for process parameterization and optimization
05.
Development and optimization of purification and isolation methods
06.
Transfer of process into GMP
07.
Troubleshooting
08.
Polymorphism Study

Reliance Rasayan offers a wide range of high purity Impurity Standards for the pharmaceutical industries on milligram to gram scale at competitive price. We have a technical capability to synthesize, isolate and purify the Impurity Standards to their purest form.

We also offer custom synthesis of impurity compounds as on requests.