Formulation Studies

From Prototype to Commercial Scale in Our U.S. GMP Facility

Overview Service

Capzerpharma Manufacturing provides comprehensive formulation studies as part of its integrated pharmaceutical development services. These studies focus on developing robust, bioequivalent generic formulations for oral solids, liquids, and other dosage forms to meet regulatory standards and accelerate market entry.

Our Approach

The company employs an in-house R&D model combining formulation development, process optimization, and scale-up from pilot to commercial batches. Expert teams utilize high-shear granulators, blending units, tablet presses, and capsule fillers to create standard and complex generics, ensuring stability and manufacturability.

Key Capabilities

Development of generics targeting chronic markets like diabetes (e.g., Empagliflozin), cardiovascular (e.g., Sacubitril/Valsartan), neurology (e.g., Gabapentin), and ophthalmics.
ICH-compliant stability programs, impurity profiling, and method validation integrated with formulation work.
Support for ANDA submissions through PAI-ready operations and regulatory expertise.

Benefits for Partners

Clients gain faster development cycles and cost efficiency from Capzerpharma’s U.S.-based GMP facility spanning 20,000 sq. ft., established in 2011. This vertically integrated platform minimizes risks and supports long-term supply reliability for OEMs and EPC partners.

Other Service

Need for help?

Our expert team is here to support you with reliable pharmaceutical testing, analytical solutions, and regulatory guidance. Whether you have a query or need a customized service, we’re ready to assist you at every step.