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Looking for 620-67-7 / Triheptanoin API manufacturers, exporters & distributors?

Triheptanoin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Triheptanoin

Synonyms

620-67-7, Propane-1,2,3-triyl triheptanoate, Trienanthoin, Trioenanthoin, Glyceryl triheptanoate, Glycerol triheptanoate

Cas Number

620-67-7

Unique Ingredient Identifier (UNII)

2P6O7CFW5K

About Triheptanoin

Triheptanoin is a source of heptanoate fatty acids, which can be metabolized without the enzymes of long chain fatty acid oxidation. In clinical trials, patients with long chain fatty acid oxidation disorders (lc-FAODs) treated with triheptanoin are less likely to develop hypoglycemia, cardiomyopathy, rhabdomyolysis, and hepatomegaly. Complications in lc-FAOD patients are reduced from approximately 60% to approximately 10% with the addition of triheptanoin. Triheptanoin was granted FDA approval on 30 June 2020.

Triheptanoin Manufacturers

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

Triheptanoin Suppliers

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

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

Triheptanoin USDMF

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

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

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

Triheptanoin 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 Triheptanoin as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Triheptanoin GMP

Triheptanoin 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 Triheptanoin 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 Triheptanoin GMP manufacturer or Triheptanoin GMP API supplier for your needs.

Triheptanoin CoA

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

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

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