Quality Control and Quality Assurance

At Synergene Active Ingredients, our overarching commitment is to consistently meet or exceed the quality expectations of our global pharmaceutical partners. To keep pace with rapid technological advances and evolving international regulations, our quality systems comply with stringent global cGMP standards.
Our robust quality management framework ensures that every batch of APIs, Intermediates, and Specialty Chemicals manufactured across our facilities meets the highest standards of safety, purity, efficacy, and regulatory compliance.

From raw material procurement and order processing to in-process controls and final shipment, every operational step is rigorously monitored to deliver assured product quality. Through continuous process improvement and strict adherence to international cGMP guidelines, we ensure our operations remain ahead of shifting global regulatory demands.

We monitor performance across the entire manufacturing lifecycle. Our quality teams conduct strict sampling and testing of raw materials, starting materials, and reagents before release. During production, detailed in-process quality checks, batch controls, and analytical characterizations (including impurity profiling and degradation studies) are executed to maintain strict process consistency.

Our state-of-the-art analytical and microbiology laboratories operate in full alignment with international pharmacopeial standards (such as USP, EP, and IP). Equipped with modern instruments subject to strict internal calibration routines, our QC labs perform comprehensive testing—including microbial limit testing, bacterial endotoxin testing (BET), stability studies, and high-precision chromatographic analyses.

Chemistry and Reactions

Cryogenic, high-pressure and chiral chemistry, from gram to multi-tonne.

Supply Chain Management

Planning, sourcing and logistics that keep supply consistent for customers in 65+ countries.

Project Management

A single point of contact for every project, from development to commercial supply.