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PharmaCompass offers a list of Omeprazole Sodium 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 Omeprazole Sodium manufacturer or Omeprazole Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Omeprazole Sodium manufacturer or Omeprazole Sodium supplier.
PharmaCompass also assists you with knowing the Omeprazole Sodium API Price utilized in the formulation of products. Omeprazole Sodium API Price is not always fixed or binding as the Omeprazole Sodium Price is obtained through a variety of data sources. The Omeprazole Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sompraz manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sompraz, including repackagers and relabelers. The FDA regulates Sompraz manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sompraz 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 Sompraz manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sompraz supplier is an individual or a company that provides Sompraz active pharmaceutical ingredient (API) or Sompraz finished formulations upon request. The Sompraz suppliers may include Sompraz API manufacturers, exporters, distributors and traders.
click here to find a list of Sompraz suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sompraz DMF (Drug Master File) is a document detailing the whole manufacturing process of Sompraz active pharmaceutical ingredient (API) in detail. Different forms of Sompraz DMFs exist exist since differing nations have different regulations, such as Sompraz USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sompraz DMF submitted to regulatory agencies in the US is known as a USDMF. Sompraz USDMF includes data on Sompraz's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sompraz USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sompraz 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 Sompraz Drug Master File in Japan (Sompraz JDMF) empowers Sompraz 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 Sompraz JDMF during the approval evaluation for pharmaceutical products. At the time of Sompraz 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 Sompraz suppliers with JDMF on PharmaCompass.
A Sompraz CEP of the European Pharmacopoeia monograph is often referred to as a Sompraz Certificate of Suitability (COS). The purpose of a Sompraz CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sompraz EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sompraz to their clients by showing that a Sompraz CEP has been issued for it. The manufacturer submits a Sompraz CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sompraz CEP holder for the record. Additionally, the data presented in the Sompraz CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sompraz DMF.
A Sompraz CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sompraz 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 Sompraz suppliers with CEP (COS) on PharmaCompass.
A Sompraz written confirmation (Sompraz WC) is an official document issued by a regulatory agency to a Sompraz manufacturer, verifying that the manufacturing facility of a Sompraz active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sompraz APIs or Sompraz finished pharmaceutical products to another nation, regulatory agencies frequently require a Sompraz WC (written confirmation) as part of the regulatory process.
click here to find a list of Sompraz suppliers with Written Confirmation (WC) on PharmaCompass.
Sompraz 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 Sompraz 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 Sompraz GMP manufacturer or Sompraz GMP API supplier for your needs.
A Sompraz CoA (Certificate of Analysis) is a formal document that attests to Sompraz's compliance with Sompraz specifications and serves as a tool for batch-level quality control.
Sompraz CoA mostly includes findings from lab analyses of a specific batch. For each Sompraz 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.
Sompraz may be tested according to a variety of international standards, such as European Pharmacopoeia (Sompraz EP), Sompraz JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sompraz USP).
