Metoprolol succinate extended-release tablets are manufactured by several companies, with the active pharmaceutical ingredient (API) often sourced from global suppliers. The "BP" designation refers to British Pharmacopoeia, indicating that the metoprolol succinate meets the standards set by this pharmacopeia for quality and purity.
Who Makes Metoprolol Succinate Extended-Release Tablets?
Several pharmaceutical companies produce metoprolol succinate extended-release tablets, including but not limited to Aurobindo Pharma, Hikma Pharmaceuticals, Teva Pharmaceuticals, and Mylan N.V. [1]. The manufacturing process involves producing the metoprolol succinate API and then formulating it into extended-release tablets.
Where Do Manufacturers Source Metoprolol Succinate API?
The active pharmaceutical ingredient (API) for metoprolol succinate is manufactured by various chemical and pharmaceutical companies worldwide. Companies like Divi's Laboratories and Lupin Limited are known API manufacturers that may supply metoprolol succinate to drug formulators [2]. The sourcing of the API can be a critical factor in the overall manufacturing cost and supply chain reliability.
What Does "BP" Mean for Metoprolol Succinate?
The "BP" designation signifies that the metoprolol succinate conforms to the specifications outlined in the British Pharmacopoeia. This ensures a certain level of quality, purity, and potency, which is essential for pharmaceutical products used in human medicine [3]. Regulatory bodies in various countries often reference pharmacopeial standards for drug quality.
What Are the Manufacturing Standards for Metoprolol Succinate?
Manufacturers of metoprolol succinate must adhere to Good Manufacturing Practices (GMP) as mandated by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These standards cover all aspects of production, from raw material sourcing and facility maintenance to quality control and record-keeping, ensuring the safety and efficacy of the final drug product [4].
How is Metoprolol Succinate Formulated into Extended-Release Tablets?
Formulating metoprolol succinate into extended-release tablets involves incorporating specific technologies to control the rate at which the drug is released into the body. This often utilizes hydrophilic matrix systems or other polymer-based technologies to ensure a slow and steady release of the active ingredient over a prolonged period, typically 24 hours [5]. This extended release is designed to provide consistent therapeutic levels and reduce dosing frequency.
What is the Patent Status of Metoprolol Succinate Products?
Metoprolol succinate has been available for some time, and many of the original patents have expired. However, manufacturers may still hold patents on specific formulations, manufacturing processes, or extended-release technologies. DrugPatentWatch.com tracks patent information for pharmaceuticals, which can indicate when market exclusivity for specific metoprolol succinate products might end [6]. The expiration of patents typically opens the door for generic competition.
What are the Generic Alternatives to Brand-Name Metoprolol Succinate?
Following patent expirations, numerous generic versions of metoprolol succinate extended-release tablets become available. These generic products are bioequivalent to the brand-name versions, meaning they deliver the same amount of active ingredient into the bloodstream at the same rate [7]. Patients and healthcare providers often opt for generic metoprolol succinate due to its lower cost.
Sources:
[1] https://www.drugpatentwatch.com/drug/metoprolol-succinate
[2] https://www.drugpatentwatch.com/api/metoprolol-succinate
[3] https://www.pharmacopoeia.com/
[4] https://www.fda.gov/drugs/guidance-compliance-regulatory-information/good-manufacturing-practice-gmp
[5] https://www.drugpatentwatch.com/blog/understanding-extended-release-drug-formulations
[6] https://www.drugpatentwatch.com/
[7] https://www.fda.gov/drugs/abbreviated-new-drug-applications-and-generics/bioequivalence