製藥與醫療保健運作於高度監管環境中，精準度、安全性、合規性與信任至為關鍵。Caldic提供GMP級原料、法規支援與從實驗室到生產的安全供應。我們協助您更快速地推出方案，確保品質、合規與穩定性
“When one of our key suppliers discontinued a pharmaceutical excipient, it created a ripple effect we had to contain quickly,” begins Fernanda Macarini, Product Development Specialist - Pharma at Caldic LATAM. “Our customer suddenly had no access to a critical component in their formulation, and the available alternative wasn’t ready.”
Excipients are essential for the stability and delivery of drugs. A substitute cannot just match specifications on paper; it has to pass rigorous quality tests, meet regulatory requirements, and perform exactly as the original in the final formulation.
“That’s where our market knowledge and technical know-how came in,” Fernanda explains. “We immediately started working with the customer’s quality control team to analyze and adapt the starch-based excipient to fit their needs.”
The path wasn’t straightforward. “Early tests didn’t go well. Solubility, density, and viscosity were all off. It didn’t meet the product requirements, and that could have put their production at risk, but we supported the customer through the complex R&D and analytical qualification stages,” she says.
We didn’t just supply the product - we got hands-on with sample prep, validation, and tailoring the excipient to make sure it passed every requirement. Our experience in the pharma market really made the difference.
Working across functions and time zones, Fernanda and her colleagues guided the customer through the homologation process. “Every test has to be aligned with regulatory expectations,” she says. “We focused on managing the key parameters precisely, so there’d be no compromise in the performance of the final drug.”
“Despite the early setbacks, we succeeded. The new excipient was approved, validated, and implemented on time and without impacting the final formulation.”
Thanks to Caldic’s combination of infrastructure, global reach, and technical skill, the customer avoided costly disruptions and continued their production seamlessly.
製藥與醫療保健運作於高度監管環境中，精準度、安全性、合規性與信任至為關鍵。Caldic提供GMP級原料、法規支援與從實驗室到生產的安全供應。我們協助您更快速地推出方案，確保品質、合規與穩定性