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Looking for 2014450-84-9 / Serdexmethylphenidate API manufacturers, exporters & distributors?

Serdexmethylphenidate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Serdexmethylphenidate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Serdexmethylphenidate manufacturer or Serdexmethylphenidate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Serdexmethylphenidate manufacturer or Serdexmethylphenidate supplier.

PharmaCompass also assists you with knowing the Serdexmethylphenidate API Price utilized in the formulation of products. Serdexmethylphenidate API Price is not always fixed or binding as the Serdexmethylphenidate Price is obtained through a variety of data sources. The Serdexmethylphenidate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Serdexmethylphenidate

Synonyms

Kp-415 inner salt, 0h8kz470dw, Pyridinium, 3-((((1s)-1-carboxy-2-hydroxyethyl)amino)carbonyl)-1-(((((2r)-2-((1r)-2-methoxy-2-oxo-1-phenylethyl)-1-piperidinyl)carbonyl)oxy)methyl)-, Unii-0h8kz470dw, Gtpl11450, Kp484

Cas Number

2014450-84-9

Unique Ingredient Identifier (UNII)

0H8KZ470DW

About Serdexmethylphenidate

Attention Deficit Hyperactivity Disorder (ADHD) is an early-onset neurodevelopmental disorder that often extends into adulthood and is characterized by developmentally inappropriate and impaired attention, impulsivity, and motor hyperactivity. The underlying cause of ADHD is unclear but likely involves dysfunction in dopaminergic and noradrenergic neurotransmission, as evidenced by the clear beneficial effect of CNS stimulants such as [methylphenidate] and [amphetamine] that increase extracellular dopamine and norepinephrine levels. Serdexmethylphenidate is a prodrug of the CNS stimulant [dexmethylphenidate], a common first-line treatment for ADHD, that is combined with [dexmethylphenidate] to provide extended plasma concentrations and therapeutic benefit with once-daily dosing. Serdexmethylphenidate was granted FDA approval on March 2, 2021, and is currently marketed as a combination capsule with [dexmethylphenidate] under the trademark AZSTARYS by KemPharm, Inc.

Serdexmethylphenidate Manufacturers

A Serdexmethylphenidate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Serdexmethylphenidate, including repackagers and relabelers. The FDA regulates Serdexmethylphenidate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Serdexmethylphenidate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Serdexmethylphenidate Suppliers

A Serdexmethylphenidate supplier is an individual or a company that provides Serdexmethylphenidate active pharmaceutical ingredient (API) or Serdexmethylphenidate finished formulations upon request. The Serdexmethylphenidate suppliers may include Serdexmethylphenidate API manufacturers, exporters, distributors and traders.

Serdexmethylphenidate NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Serdexmethylphenidate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Serdexmethylphenidate API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Serdexmethylphenidate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Serdexmethylphenidate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Serdexmethylphenidate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Serdexmethylphenidate suppliers with NDC on PharmaCompass.

Serdexmethylphenidate GMP

Serdexmethylphenidate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Serdexmethylphenidate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Serdexmethylphenidate GMP manufacturer or Serdexmethylphenidate GMP API supplier for your needs.

Serdexmethylphenidate CoA

A Serdexmethylphenidate CoA (Certificate of Analysis) is a formal document that attests to Serdexmethylphenidate's compliance with Serdexmethylphenidate specifications and serves as a tool for batch-level quality control.

Serdexmethylphenidate CoA mostly includes findings from lab analyses of a specific batch. For each Serdexmethylphenidate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Serdexmethylphenidate may be tested according to a variety of international standards, such as European Pharmacopoeia (Serdexmethylphenidate EP), Serdexmethylphenidate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Serdexmethylphenidate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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