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Looking for 1392826-25-3 / Deutetrabenazine API manufacturers, exporters & distributors?

Deutetrabenazine manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Deutetrabenazine 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 Deutetrabenazine manufacturer or Deutetrabenazine supplier for your needs.

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

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

API | Excipient name

Deutetrabenazine

Synonyms

Dutetrabenazine, P341g6w9nb, Sd-809, (3rs,11brs)-9,10-di((2h3)methoxy)-3-(2-methylpropyl)-1,3,4,6,7,11b-hexahydro-2h-benzo(a)quinolizin-2-one, 2h-benzo(a)quinolizin-2-one, 1,3,4,6,7,11b-hexahydro-9,10-di(methoxy-d3)-3-(2-methylpropyl)-, (3r,11br)-rel-, Sd809

Cas Number

1392826-25-3

Unique Ingredient Identifier (UNII)

P341G6W9NB

About Deutetrabenazine

Deutetrabenazine is a novel, highly selective vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the management of chorea associated with Huntingtons disease. It is a hexahydro-dimethoxybenzoquinolizine derivative and a deuterated [DB04844]. The presence of deuterium in deutetrabenazine increases the half-lives of the active metabolite and prolongs their pharmacological activity by attenuating CYP2D6 metabolism of the compound. This allows less frequent dosing and a lower daily dose with improvement in tolerability. Decreased plasma fluctuations of deutetrabenazine due to attenuated metabolism may explain a lower incidence of adverse reactions associated with deutetrabenazine. Deutetrabenazine is a racemic mixture containing RR-Deutetrabenazine and SS-Deutetrabenazine. Huntington's disease (HD) is a hereditary, progressive neurodegenerative disorder characterized by motor dysfunction, cognitive decline, and neuropsychiatric disturbances that interfere with daily functioning and significantly reduce the quality of life. The most prominent physical symptom of HD that may increase the risk of injury is chorea, which is an involuntary, sudden movement that can affect any muscle and flow randomly across body regions. Psychomotor symptoms of HD, such as chorea, are related to hyperactive dopaminergic neurotransmission. Deutetrabenazine depletes the levels of presynaptic dopamine by blocking VMAT2, which is responsible for the uptake of dopamine into synaptic vesicles in monoaminergic neurons and exocytotic release. As with other agents for the treatment of neurodegenerative diseases, deutetrabenazine is a drug to alleviate the motor symptoms of HD and is not proposed to halt the progression of the disease. In clinical trials of patients with HD, 12 weeks of treatment of deutetrabenazine resulted in overall improvement in mean total maximal chorea scores and motor signs than placebo. It was approved by FDA in April 2017 and is marketed under the trade name Austedo as oral tablets.

Tetrabenazine D6 Manufacturers

A Tetrabenazine D6 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tetrabenazine D6, including repackagers and relabelers. The FDA regulates Tetrabenazine D6 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tetrabenazine D6 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Tetrabenazine D6 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Tetrabenazine D6 Suppliers

A Tetrabenazine D6 supplier is an individual or a company that provides Tetrabenazine D6 active pharmaceutical ingredient (API) or Tetrabenazine D6 finished formulations upon request. The Tetrabenazine D6 suppliers may include Tetrabenazine D6 API manufacturers, exporters, distributors and traders.

click here to find a list of Tetrabenazine D6 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Tetrabenazine D6 USDMF

A Tetrabenazine D6 DMF (Drug Master File) is a document detailing the whole manufacturing process of Tetrabenazine D6 active pharmaceutical ingredient (API) in detail. Different forms of Tetrabenazine D6 DMFs exist exist since differing nations have different regulations, such as Tetrabenazine D6 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Tetrabenazine D6 DMF submitted to regulatory agencies in the US is known as a USDMF. Tetrabenazine D6 USDMF includes data on Tetrabenazine D6's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tetrabenazine D6 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Tetrabenazine D6 suppliers with USDMF on PharmaCompass.

Tetrabenazine D6 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 Tetrabenazine D6 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Tetrabenazine D6 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 Tetrabenazine D6 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 Tetrabenazine D6 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tetrabenazine D6 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Tetrabenazine D6 suppliers with NDC on PharmaCompass.

Tetrabenazine D6 GMP

Tetrabenazine D6 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 Tetrabenazine D6 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 Tetrabenazine D6 GMP manufacturer or Tetrabenazine D6 GMP API supplier for your needs.

Tetrabenazine D6 CoA

A Tetrabenazine D6 CoA (Certificate of Analysis) is a formal document that attests to Tetrabenazine D6's compliance with Tetrabenazine D6 specifications and serves as a tool for batch-level quality control.

Tetrabenazine D6 CoA mostly includes findings from lab analyses of a specific batch. For each Tetrabenazine D6 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.

Tetrabenazine D6 may be tested according to a variety of international standards, such as European Pharmacopoeia (Tetrabenazine D6 EP), Tetrabenazine D6 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tetrabenazine D6 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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