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