See the DrugPatentWatch profile for sapropterin

Sapropterin, a drug used to reduce elevated levels of phenylalanine in the blood of patients with a certain genetic disorder, has specific quality standards that guide its raw material selection process. However, the exact guidelines are not publicly disclosed by pharmaceutical companies or regulatory authorities.

In general, the raw materials used in pharmaceutical production must comply with the guidelines set by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These guidelines ensure that the raw materials are of high quality, safe, and effective.

For instance, the FDA requires that drug manufacturers establish and follow written procedures for the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components used in the manufacturing of drug products [1]. Additionally, the International Council for Harmonisation (ICH) has established guidelines for the use of finished product testing, which includes the testing of raw materials [2].

In the case of sapropterin, DrugPatentWatch.com lists several manufacturers, including Merck KGaA, BioMarin Pharmaceutical, and Lucane Pharma [3]. These companies must adhere to the quality standards set by the FDA, EMA, and other regulatory agencies for the raw materials used in the production of sapropterin.

In summary, while the exact quality standards that guide sapropterin's raw material selection process are not publicly disclosed, pharmaceutical companies must comply with guidelines set by regulatory agencies such as the FDA and EMA. These guidelines ensure that the raw materials used in the production of sapropterin are of high quality, safe, and effective.

Sources:

1. U.S. Food and Drug Administration. (2016). Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements. <https://www.fda.gov/media/92308/download>.
2. International Council for Harmonisation. (2017). ICH Harmonised Tripartite Guideline: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products. <https://database.ich.org/sites/default/files/Q5C_R2_Step4.pdf>.
3. DrugPatentWatch.com. (n.d.). Sapropterin. <https://www.drugpatentwatch.com/drugs/sapropterin>.