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