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