SPL documents contain both the content of labeling (all text, tables and figures) for a product along with additional machine readable information (including drug listing data elements and clinical data elements). Drug listing data elements include coded information about the product (including product and generic names, ingredients, ingredient strengths, dosage forms, routes of administration, appearance, DEA schedule) and the packaging (package quantity and type). Clinical data elements include coded information about the clinical use of the product (including indications and use, contraindications, drug interactions, warning and precautions and use in special populations).
Dragon Pharmaceutical Inc. is an international biopharmaceutical corporation engaged in the discovery, development and commercialization of genetically engineered human proteins for therapeutic use. Based on its proprietary protein expression technology, Dragon believes that it has become one of the world’s most competitive producers of Erythropoietin (EPO) a breakthrough drug that has revolutionized the treatment of anemia. Dragon is also applying its platform technology to the development of other generic and novel protein drugs.