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