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PharmaCompass offers a list of Succinate 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 Succinate manufacturer or Succinate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Succinate manufacturer or Succinate supplier.
PharmaCompass also assists you with knowing the Succinate API Price utilized in the formulation of products. Succinate API Price is not always fixed or binding as the Succinate Price is obtained through a variety of data sources. The Succinate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Succinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Succinate, including repackagers and relabelers. The FDA regulates Succinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Succinate 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 Succinate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Succinate supplier is an individual or a company that provides Succinate active pharmaceutical ingredient (API) or Succinate finished formulations upon request. The Succinate suppliers may include Succinate API manufacturers, exporters, distributors and traders.
click here to find a list of Succinate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Succinate DMF (Drug Master File) is a document detailing the whole manufacturing process of Succinate active pharmaceutical ingredient (API) in detail. Different forms of Succinate DMFs exist exist since differing nations have different regulations, such as Succinate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Succinate DMF submitted to regulatory agencies in the US is known as a USDMF. Succinate USDMF includes data on Succinate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Succinate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Succinate 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 Succinate Drug Master File in Japan (Succinate JDMF) empowers Succinate 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 Succinate JDMF during the approval evaluation for pharmaceutical products. At the time of Succinate 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 Succinate suppliers with JDMF on PharmaCompass.
Succinate 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 Succinate 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 Succinate GMP manufacturer or Succinate GMP API supplier for your needs.
A Succinate CoA (Certificate of Analysis) is a formal document that attests to Succinate's compliance with Succinate specifications and serves as a tool for batch-level quality control.
Succinate CoA mostly includes findings from lab analyses of a specific batch. For each Succinate 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.
Succinate may be tested according to a variety of international standards, such as European Pharmacopoeia (Succinate EP), Succinate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Succinate USP).
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