API Section
RBPL has set up a state-of-the-art facility approved under schedule “M” to manufacture active pharmaceutical ingredients and to further formulate them into encapsulated drug products. The facility focuses primarily on development and manufacturing of clinical trial materials under GMP conditions.
RBPL focuses on the development of new chemical entities for various life-threatening disorders and then undertaking pre-clinical and clinical investigations in the same. In such cases it is imperative to have a manufacturing facility attached to the R & D unit and hence the clinical trial doses can be prepared under the supervision and control of Rasayani scientists..
The FDA approved facility has two distinctly separate sections : These Two Sections compliment each other and have been approved by the state regulatory body. The facility is under controlled environment as per the requirements of schedule “M”.
API Manufacturing
Involves a wide array of complex chemical or biological processes
Formulation : Encapsulation
Allows access to a level without revealing the complex details below that level. It reduces human errors.
RBL– The Conclusion
RBPL’s Manufacturing Facility is uniquely placed to generate samples for Clinical Trials and is perhaps one of the few dedicated facilities attached to a R & D Center.