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