Quality ingredients for a healthier world.

Challenge

The client was sourcing citric acid anhydrous from multiple local traders. Quality varied between batches, COAs were often missing or mismatched, and plants in different states faced unpredictable lead times. This caused formulation inconsistencies and production delays.

Approach

Audited existing supplier documentation and identified gaps in COA parameters and batch traceability.

Challenge

The client was launching a new oral solid dosage form for the European market and required IP/BP-grade excipients including citric acid anhydrous, glycerin, and propylene glycol. Their existing suppliers could not provide updated pharmacopoeial declarations and stability data, delaying the dossier submission.

Approach

Reviewed the formulation requirements and identified the required pharmacopoeial grades for each excipient.

Challenge

The client’s effluent treatment plant was facing inconsistent solids removal and pH fluctuations. Ferric chloride quality varied between suppliers, caustic soda concentration was inconsistent, and the plant team lacked structured documentation for environmental audits.

Approach

Visited the ETP to understand flow rate, effluent characteristics, and existing dosing practices.