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