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Looking for 1077-28-7 / Alpha Lipoic Acid API manufacturers, exporters & distributors?

Alpha Lipoic Acid manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Alpha Lipoic Acid 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 Alpha Lipoic Acid manufacturer or Alpha Lipoic Acid supplier for your needs.

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

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

API | Excipient name

Alpha Lipoic Acid

Synonyms

Dl-thioctic acid, Alpha-lipoic acid, 1077-28-7, 5-(1,2-dithiolan-3-yl)pentanoic acid, Dl-alpha-lipoic acid, 1,2-dithiolane-3-pentanoic acid

Cas Number

1077-28-7

Unique Ingredient Identifier (UNII)

73Y7P0K73Y

About Alpha Lipoic Acid

An octanoic acid bridged with two sulfurs so that it is sometimes also called a pentanoic acid in some naming schemes. It is biosynthesized by cleavage of LINOLEIC ACID and is a coenzyme of oxoglutarate dehydrogenase (KETOGLUTARATE DEHYDROGENASE COMPLEX). It is used in DIETARY SUPPLEMENTS.

alphaVibolex Manufacturers

A alphaVibolex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of alphaVibolex, including repackagers and relabelers. The FDA regulates alphaVibolex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. alphaVibolex 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 alphaVibolex manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

alphaVibolex Suppliers

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

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

alphaVibolex USDMF

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

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

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

alphaVibolex JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The alphaVibolex Drug Master File in Japan (alphaVibolex JDMF) empowers alphaVibolex API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the alphaVibolex JDMF during the approval evaluation for pharmaceutical products. At the time of alphaVibolex JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of alphaVibolex suppliers with JDMF on PharmaCompass.

alphaVibolex KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a alphaVibolex Drug Master File in Korea (alphaVibolex KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of alphaVibolex. The MFDS reviews the alphaVibolex KDMF as part of the drug registration process and uses the information provided in the alphaVibolex KDMF to evaluate the safety and efficacy of the drug.

After submitting a alphaVibolex KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their alphaVibolex API can apply through the Korea Drug Master File (KDMF).

click here to find a list of alphaVibolex suppliers with KDMF on PharmaCompass.

alphaVibolex CEP

A alphaVibolex CEP of the European Pharmacopoeia monograph is often referred to as a alphaVibolex Certificate of Suitability (COS). The purpose of a alphaVibolex CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of alphaVibolex EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of alphaVibolex to their clients by showing that a alphaVibolex CEP has been issued for it. The manufacturer submits a alphaVibolex CEP (COS) as part of the market authorization procedure, and it takes on the role of a alphaVibolex CEP holder for the record. Additionally, the data presented in the alphaVibolex CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the alphaVibolex DMF.

A alphaVibolex CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. alphaVibolex CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of alphaVibolex suppliers with CEP (COS) on PharmaCompass.

alphaVibolex WC

A alphaVibolex written confirmation (alphaVibolex WC) is an official document issued by a regulatory agency to a alphaVibolex manufacturer, verifying that the manufacturing facility of a alphaVibolex active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting alphaVibolex APIs or alphaVibolex finished pharmaceutical products to another nation, regulatory agencies frequently require a alphaVibolex WC (written confirmation) as part of the regulatory process.

click here to find a list of alphaVibolex suppliers with Written Confirmation (WC) on PharmaCompass.

alphaVibolex 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 alphaVibolex as an active pharmaceutical ingredient (API).

Finished drug products

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

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

alphaVibolex GMP

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

alphaVibolex CoA

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

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

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