Accelerating drug development with stable and compliant drug formulations

Syngene offers Formulation Development services to help clients determine optimal dosage levels for therapeutic formulations in oral solid, liquid, and injectable forms. Our integrated services extend to new chemical entities (NCE), late-phase product development, and over-the-counter products with a focus on quality, speed, and cost-efficiency.

Capabilities

Our strong scientific team has broad experience and expertise in collaborative practices with a global customer base for Formulation Development services and analytical support.

We cater to pharmaceutical companies worldwide, providing extensive pre-formulation studies, toxicology formulation, Formulation Development, and analytical method development and validation. Our services include conducting stability studies as per the guidelines of The international council for harmonisation of technical requirements for pharmaceuticals for human use (ICH) and regulatory dossier preparation. We also perform process optimization and scale-up activities, and manufacturing of clinical batches in a current good manufacturing practice (cGMP) environment.

Infrastructure

Syngene has a well-established Formulation Development centre that develops and manufactures oral solid and liquid dosage forms including injectable formulations. Our facility’s layout follows cGMP guidelines and Schedule ‘M’ of the Drugs and Cosmetics Act. The laboratory is spread across an area of 6000 square feet and supports Formulation Development for a scale of 0.1 to 5 kilograms.

The entire facility is covered with non-progressive acid proof and anti-fungal modular panels as well as pressure differentials to prevent cross contamination. We have segregated areas for change rooms, air handling unit (AHU) zoning, and man-material flow. The facility has 100% power back-up, abundant portable water, and an adequate waste management system.