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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.
A Alpha Lipoic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alpha Lipoic Acid, including repackagers and relabelers. The FDA regulates Alpha Lipoic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alpha Lipoic Acid 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 Alpha Lipoic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alpha Lipoic Acid supplier is an individual or a company that provides Alpha Lipoic Acid active pharmaceutical ingredient (API) or Alpha Lipoic Acid finished formulations upon request. The Alpha Lipoic Acid suppliers may include Alpha Lipoic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Alpha Lipoic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alpha Lipoic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Alpha Lipoic Acid active pharmaceutical ingredient (API) in detail. Different forms of Alpha Lipoic Acid DMFs exist exist since differing nations have different regulations, such as Alpha Lipoic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alpha Lipoic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Alpha Lipoic Acid USDMF includes data on Alpha Lipoic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alpha Lipoic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alpha Lipoic Acid suppliers with USDMF on PharmaCompass.
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 Alpha Lipoic Acid Drug Master File in Japan (Alpha Lipoic Acid JDMF) empowers Alpha Lipoic Acid 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 Alpha Lipoic Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Alpha Lipoic Acid 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 Alpha Lipoic Acid suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Alpha Lipoic Acid Drug Master File in Korea (Alpha Lipoic Acid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Alpha Lipoic Acid. The MFDS reviews the Alpha Lipoic Acid KDMF as part of the drug registration process and uses the information provided in the Alpha Lipoic Acid KDMF to evaluate the safety and efficacy of the drug.
After submitting a Alpha Lipoic Acid 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 Alpha Lipoic Acid API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Alpha Lipoic Acid suppliers with KDMF on PharmaCompass.
A Alpha Lipoic Acid CEP of the European Pharmacopoeia monograph is often referred to as a Alpha Lipoic Acid Certificate of Suitability (COS). The purpose of a Alpha Lipoic Acid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Alpha Lipoic Acid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Alpha Lipoic Acid to their clients by showing that a Alpha Lipoic Acid CEP has been issued for it. The manufacturer submits a Alpha Lipoic Acid CEP (COS) as part of the market authorization procedure, and it takes on the role of a Alpha Lipoic Acid CEP holder for the record. Additionally, the data presented in the Alpha Lipoic Acid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Alpha Lipoic Acid DMF.
A Alpha Lipoic Acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Alpha Lipoic Acid 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 Alpha Lipoic Acid suppliers with CEP (COS) on PharmaCompass.
A Alpha Lipoic Acid written confirmation (Alpha Lipoic Acid WC) is an official document issued by a regulatory agency to a Alpha Lipoic Acid manufacturer, verifying that the manufacturing facility of a Alpha Lipoic Acid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Alpha Lipoic Acid APIs or Alpha Lipoic Acid finished pharmaceutical products to another nation, regulatory agencies frequently require a Alpha Lipoic Acid WC (written confirmation) as part of the regulatory process.
click here to find a list of Alpha Lipoic Acid suppliers with Written Confirmation (WC) on PharmaCompass.
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 Alpha Lipoic Acid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Alpha Lipoic Acid API and other APIs are published in this directory by the FDA.
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 Alpha Lipoic Acid 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.
The NDC directory also contains data on finished compounded human drug products that contain Alpha Lipoic Acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Alpha Lipoic Acid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Alpha Lipoic Acid suppliers with NDC on PharmaCompass.
Alpha Lipoic Acid 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 Alpha Lipoic Acid 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 Alpha Lipoic Acid GMP manufacturer or Alpha Lipoic Acid GMP API supplier for your needs.
A Alpha Lipoic Acid CoA (Certificate of Analysis) is a formal document that attests to Alpha Lipoic Acid's compliance with Alpha Lipoic Acid specifications and serves as a tool for batch-level quality control.
Alpha Lipoic Acid CoA mostly includes findings from lab analyses of a specific batch. For each Alpha Lipoic Acid 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.
Alpha Lipoic Acid may be tested according to a variety of international standards, such as European Pharmacopoeia (Alpha Lipoic Acid EP), Alpha Lipoic Acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alpha Lipoic Acid USP).
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