All suppliers and contractors also are mandated to follow GMP, and they, as well as BioMarin, are subject to inspection and review. BioMarins facility has received both FDA and European Commission approval. Commercialization plan
Aldurazyme is manufactured by BioMarin in California. It is commercialized and distributed by Genzyme in the United States, the European Union, and worldwide. The patent for Aldurazyme was filed by BioMarin on November 12, 1999, patent no. US 6426208 B1, "Recombinant α-L-iduronidase, methods for producing and purifying the same and methods for treating diseases caused by deficiencies thereof".Aldurazyme yielded a net $105.6 million net product revenue out of $738.4 million in net profit revenues in 2014, $83.6 million out of $538.4 million in 2013, and $82.2 million out of $496.5 million in 2012, making it BioMarins third-most profitable product behind Naglazyme and Kuvan. In 2011, Aldurazyme yielded a net product revenue of $82.8 million out of $437.6 million net revenue, and in 2010 it netted $71.2 million out of $369.7 million in net product revenues. Aldurazyme netted $70.2 million in profit revenues in 2009 out of a total $315.7 $72.5 million in revenue were netted in 2008 out of Biomarins $251.9 million in product revenues that year.BioMarin described its business strategy as the following in their 2014 United States Securities and Exchange Commission Form 10-K:

BioMarin Pharmaceutical Inc. (BioMarin, we, us or our) develops and commercializes innovative pharmaceuticals for serious diseases and medical conditions.
Iduronidase (EC 3.2.1.76, L-iduronidase, alpha-L-iduronidase, laronidase), sold as Aldurazyme, is an enzyme with the systematic name glycosaminoglycan alpha-L-iduronohydrolase. This enzyme catalyses the hydrolysis of unsulfated alpha-L-iduronosidic linkages in dermatan sulfate.It is a glycoprotein enzyme found in the lysosomes of cells. It is involved in the degeneration of glycosaminoglycans such as dermatan sulfate and heparan sulfate. The enzyme acts by hydrolyzing the terminal alpha-L-iduronic acid residues of these molecules, degrading them. The protein is reported as having a mass of approximately 83 kilodaltons. Pathology
A deficiency in the IDUA protein is associated with mucopolysaccharidoses (MPS). MPS, a type of lysosomal storage disease, is typed I through VII. Type I is known as Hurler syndrome and type I,S is known as Scheie syndrome, which has a milder prognosis compared to Hurlers. In this syndrome, glycosaminoglycans accumulate in the lysosomes and cause substantial disease in many different tissues of the body. IDUA mutations result in the MPS 1 phenotype, which is inherited in an autosomal recessive fashion. The defective alpha-L-iduronidase results in an accumulation of heparan and dermatan sulfate within phagocytes, endothelium, smooth muscle cells, neurons, and fibroblasts. Under electron microscopy these structures present as laminated structures called Zebra bodies. Prenatal diagnosis of this enzyme deficiency is possible. Aldurazyme
General
Aldurazyme is the name of the commercialized variant of the enzyme iduronidase, which hydrolyzes the alpha-L-iduronic acid residues of dermatan sulfate and heparin sulfate. Produced in Chinese hamster ovaries by recombinant DNA technology, Aldurazyme is the manufactured by BioMarin Pharmaceutical Inc. and distributed by Genzyme Corporation (a subsidiary of Sanofi).