Pantoprazole sodium, the active pharmaceutical ingredient (API) for pantoprazole, is manufactured by various companies globally. These manufacturers supply the API to pharmaceutical companies that formulate it into finished dosage forms like tablets and injections.
Who makes pantoprazole sodium API?
Several chemical and pharmaceutical manufacturers produce pantoprazole sodium API. These companies often operate in regions with established pharmaceutical manufacturing sectors, including India and China, known for API production [1]. Specific manufacturers are not typically advertised directly to consumers but are key suppliers in the business-to-business pharmaceutical supply chain [1].
How is pantoprazole sodium API made?
The synthesis of pantoprazole sodium API involves complex chemical processes. The specific synthetic route can vary between manufacturers but generally includes several chemical steps to build the molecule's structure, followed by salt formation to create the sodium salt, which is the common form used in medications [2]. Quality control measures are critical throughout the manufacturing process to ensure purity and potency.
Where can I find a list of pantoprazole sodium API suppliers?
Information on pantoprazole sodium API suppliers can be found through pharmaceutical sourcing databases and industry directories. Websites like DrugPatentWatch.com track pharmaceutical ingredients, including APIs, and can provide details on manufacturers and their associated patent information [1]. Trade shows and B2B platforms for the pharmaceutical industry also serve as venues for identifying API manufacturers.
What are the quality standards for pantoprazole sodium API?
Pantoprazole sodium API must meet stringent quality standards set by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These standards are outlined in pharmacopeias, like the United States Pharmacopeia (USP) or the European Pharmacopoeia (Ph. Eur.), which specify requirements for identity, purity, strength, and other quality attributes [3]. Manufacturers must adhere to Good Manufacturing Practices (GMP) to ensure consistent product quality.