Securing Provision K Status for a Client’s API Helps to Expedite Shipping and Reduce US Importation Costs

10 Mar 2014

This case study presents an example of how Marken — a global life sciences supply chain solutions company — helped a client avoid inappropriate duty charges and expedite importation of its API into the US.

Marken API Services

Marken

Marken’s network fulfills the global movement of API from the point of manufacturing to CMOs and primary packagers. Marken optimizes API logistics around the globe with continuous temperature monitoring, documented transit custody and a worldwide network of offices, providing end-to-end quality-assured supply chain services.With Marken’s experience and expertise they excel in assisting companies to achieve the most expeditious movement of API’s across country borders. By working closely with customs officials, licensed customs brokers, and using their knowledge of import and trade compliance regulations, Marken is able to provide their customers with all of the details necessary to achieve the lowest possible duty and avoid delays each time a product is being shipped.Logistics capabilities offered for all ranges of temperature control include: Complete real-time reporting of the status of shipments Manufacturing supply chain expertise Customs preclearance Packaging, documentation and declarations consulting Regulatory and import/export license assistance and advice Insurance coverage

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Drug DeliveryDrug Delivery refers to dosage form, route of administration, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. Drug delivery is often approached via the biopharmaceutical or small molecule drug's formulation, but it may also involve medical devices or drug-device combination products. Considerations include instrumentation, software and services. Shipping / PackagingPackaging is the technology of enclosing or protecting products for distribution, storage, sale, and use and the process and production of packages. Packaging is closely linked to Shipping and the preparing of goods for transport, warehousing, logistics, sale, and end use. Within the pharmaceutical industry packaging and shipping are used for transport, storage and logistics between Contract Research Organizations (CROs), Manufacturing and Clinical Trial companies. Packaging is also critical in the final production of a pharmaceutical product before market. RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. PharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.Active PharmaceuticalsThe Active Pharmaceutical Ingredient (API) of a drug is the component that causes the direct effect of the product. The remaining inactive components are known as excipients.