Calcium Carbonate is widely used in pharmaceutical and nutraceutical formulations due to its high calcium content, excellent stability, and cost effectiveness. A reputed Indian pharmaceutical formulation manufacturer required a reliable domestic source of pharma-grade Calcium Carbonate with consistent quality. Compliance with IP, BP, USP, and EP standards was a key requirement to support multiple regulated markets. To meet these needs, the manufacturer partnered with GMICare Lifesciences LLP (GMI) for a dependable and compliant excipient solution.
Client Challenges
- Dependence on imported calcium carbonate
- Long lead time (8–10 weeks)
- High procurement cost
- Batch-to-batch variability affecting tablet hardness
- Strict control required on heavy metals and assay
GMI Solution:
GMICare Lifesciences LLP evaluated the customer’s formulation needs and identified key issues related to assay consistency, particle size, and impurity control. Based on this assessment, GMI supplied pharma-grade Calcium Carbonate manufactured with high and consistent calcium assay and an optimized particle size suitable for tablet formulations, ensuring uniform compressibility and improved hardness. Strict control of heavy metals ensures full compliance with IP, BP, USP, and EP standards. Comprehensive documentation and technical support were provided throughout trials. Successful validation confirmed consistent performance and enabled a smooth transition to a reliable domestic supply.Results & Performance:
- Tablet hardness improved by 15–20%
- Excellent tablet appearance and uniform whiteness
- Reduced tablet breakage during handling
- Consistent batch-to-batch performance
- Procurement lead time reduced to 1–2 weeks
- Reduced tablet rejections improved overall manufacturing profitability by 8–10%.