From Sourcing to Supply: Caldic's End-to-End Solutions for API Excellence

Caldic's API Sourcing Advantages

	API Sourcing Access a trusted global network of high-quality API suppliers.		Dual Sourcing Ensure supply chain resilience with reliable secondary sources.
	Regulatory Support Navigate complex pharmaceutical regulations with expert guidance.		Qualification/Documentation Provide service on qualifying API’s and securing documentation.
	Compliance Maintain full adherence to industry standards and requirements.		Risk Mitigation Proactively address challenges to safeguard your operations.
	DMF Management Streamline your documentation and compliance needs.		Multicompendial Support for APIs across global pharmacopeias standards.

Comprehensive Sourcing Solutions

At Caldic, our teams are dedicated to the sourcing, sale and distribution of APIs. With extensive expertise and a steadfast commitment to quality, demonstrated through rigorous Standard Operating Procedures (SOPs) and strict adherence to regulatory compliance, we offer a superior sourcing service. Entering the API market requires an official API registration granted by health authorities or medical agencies in alignment with EU regulations. This registration is essential for ensuring compliance with all operational and safety standards. Caldic holds the necessary import, export and distribution licenses, which are significant hurdles in the sector, and, more importantly, also manages the complexities of API shipping and storage. All shipping companies used by Caldic are approved for API transport, and our warehousing facilities are specially authorized for API handling. This comprehensive approach guarantees that all products meet the stringent quality standards set by regulatory bodies, ensuring seamless market entry and operations for our clients.

A Global Network at Your Fingertips

Working with Caldic provides you with unique access to our vast network of suppliers and a diverse range of API products. This global network is expansive and thoroughly vetted, and gives our clients an upper edge, with a range of solutions that are competitively priced and unmatched in quality.

Advancing Quality Assurance in Supplier Qualification

The qualification stage is crucial in the API sourcing process and involves the rigorous evaluation of potential suppliers and products to meet specific quality and regulatory standards. Our API house excels in this area, offering comprehensive support to navigate the qualification process efficiently, ensuring that new suppliers and products are approved swiftly, maintaining the speed and agility needed in the fast-paced pharmaceutical market.

Expedited Service and Comprehensive Documentation

Our API house service is designed to provide fast, reliable access to the necessary APIs, accompanied by comprehensive documentation covering licenses, quality requirements, and logistics. This commitment to speed does not come at the expense of detail — every aspect of the sourcing and distribution process is meticulously documented, making sure clients have all the information they need for regulatory compliance and quality assurance.

Ensuring Quality with GDP-Compliant Warehousing

Good Distribution Practice (GDP) warehousing is essential for maintaining the quality and integrity of pharmaceutical products. Our access to GDP-compliant warehousing facilities ensures that APIs are stored and handled according to the highest standards, further underlining its commitment to quality. These facilities are equipped with the latest technologies for storage and logistics guaranteeing their availability for timely delivery to clients.

Empowering the Pharmaceutical Industry with Caldic's API House Services

Our API house services represent a holistic solution for pharmaceutical companies navigating the complexities of API sourcing. With a focus on regulatory compliance, an extensive network of suppliers, and a commitment to quality and efficiency, Caldic sets a new standard in the industry. Whether it's managing the qualification of new suppliers, providing expedited service and comprehensive documentation, or offering access to GDP-compliant warehousing, we ensure that our clients are well-equipped to meet the demands of the global pharmaceutical market.

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Want to learn more? Do not hesitate to reach out by sending us an email at p.isager@caldic.com.