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