Synopsis
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KDMF
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VMF
DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
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API Imports and Exports
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
Rochem International Inc
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Pamidronate 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 Pamidronate manufacturer or Pamidronate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pamidronate manufacturer or Pamidronate supplier.
PharmaCompass also assists you with knowing the Pamidronate API Price utilized in the formulation of products. Pamidronate API Price is not always fixed or binding as the Pamidronate Price is obtained through a variety of data sources. The Pamidronate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Disodium Pamidronate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Disodium Pamidronate, including repackagers and relabelers. The FDA regulates Disodium Pamidronate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Disodium Pamidronate 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 Disodium Pamidronate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Disodium Pamidronate supplier is an individual or a company that provides Disodium Pamidronate active pharmaceutical ingredient (API) or Disodium Pamidronate finished formulations upon request. The Disodium Pamidronate suppliers may include Disodium Pamidronate API manufacturers, exporters, distributors and traders.
click here to find a list of Disodium Pamidronate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Disodium Pamidronate DMF (Drug Master File) is a document detailing the whole manufacturing process of Disodium Pamidronate active pharmaceutical ingredient (API) in detail. Different forms of Disodium Pamidronate DMFs exist exist since differing nations have different regulations, such as Disodium Pamidronate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Disodium Pamidronate DMF submitted to regulatory agencies in the US is known as a USDMF. Disodium Pamidronate USDMF includes data on Disodium Pamidronate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Disodium Pamidronate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Disodium Pamidronate 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 Disodium Pamidronate Drug Master File in Japan (Disodium Pamidronate JDMF) empowers Disodium Pamidronate 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 Disodium Pamidronate JDMF during the approval evaluation for pharmaceutical products. At the time of Disodium Pamidronate 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 Disodium Pamidronate suppliers with JDMF on PharmaCompass.
A Disodium Pamidronate CEP of the European Pharmacopoeia monograph is often referred to as a Disodium Pamidronate Certificate of Suitability (COS). The purpose of a Disodium Pamidronate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Disodium Pamidronate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Disodium Pamidronate to their clients by showing that a Disodium Pamidronate CEP has been issued for it. The manufacturer submits a Disodium Pamidronate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Disodium Pamidronate CEP holder for the record. Additionally, the data presented in the Disodium Pamidronate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Disodium Pamidronate DMF.
A Disodium Pamidronate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Disodium Pamidronate 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 Disodium Pamidronate suppliers with CEP (COS) on PharmaCompass.
A Disodium Pamidronate written confirmation (Disodium Pamidronate WC) is an official document issued by a regulatory agency to a Disodium Pamidronate manufacturer, verifying that the manufacturing facility of a Disodium Pamidronate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Disodium Pamidronate APIs or Disodium Pamidronate finished pharmaceutical products to another nation, regulatory agencies frequently require a Disodium Pamidronate WC (written confirmation) as part of the regulatory process.
click here to find a list of Disodium Pamidronate 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 Disodium Pamidronate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Disodium Pamidronate 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 Disodium Pamidronate 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 Disodium Pamidronate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Disodium Pamidronate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Disodium Pamidronate suppliers with NDC on PharmaCompass.
Disodium Pamidronate 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 Disodium Pamidronate 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 Disodium Pamidronate GMP manufacturer or Disodium Pamidronate GMP API supplier for your needs.
A Disodium Pamidronate CoA (Certificate of Analysis) is a formal document that attests to Disodium Pamidronate's compliance with Disodium Pamidronate specifications and serves as a tool for batch-level quality control.
Disodium Pamidronate CoA mostly includes findings from lab analyses of a specific batch. For each Disodium Pamidronate 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.
Disodium Pamidronate may be tested according to a variety of international standards, such as European Pharmacopoeia (Disodium Pamidronate EP), Disodium Pamidronate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Disodium Pamidronate USP).
