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API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - EQ 10MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20560
DOSAGE - TABLET;ORAL - EQ 35MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20560
DOSAGE - TABLET;ORAL - EQ 40MG BASE **Federal...DOSAGE - TABLET;ORAL - EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20560
DOSAGE - TABLET;ORAL - EQ 5MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20560
DOSAGE - TABLET;ORAL - EQ 70MG BASE
USFDA APPLICATION NUMBER - 20560
DOSAGE - TABLET;ORAL - EQ 70MG BASE;2,800 IU
USFDA APPLICATION NUMBER - 21762
DOSAGE - TABLET;ORAL - EQ 70MG BASE;5,600 IU
USFDA APPLICATION NUMBER - 21762
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ABOUT THIS PAGE
47
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 Alend manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alend, including repackagers and relabelers. The FDA regulates Alend manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alend 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 Alend manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alend supplier is an individual or a company that provides Alend active pharmaceutical ingredient (API) or Alend finished formulations upon request. The Alend suppliers may include Alend API manufacturers, exporters, distributors and traders.
click here to find a list of Alend suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Alend DMF (Drug Master File) is a document detailing the whole manufacturing process of Alend active pharmaceutical ingredient (API) in detail. Different forms of Alend DMFs exist exist since differing nations have different regulations, such as Alend USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alend DMF submitted to regulatory agencies in the US is known as a USDMF. Alend USDMF includes data on Alend's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alend USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alend 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 Alend Drug Master File in Japan (Alend JDMF) empowers Alend 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 Alend JDMF during the approval evaluation for pharmaceutical products. At the time of Alend 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 Alend 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 Alend Drug Master File in Korea (Alend KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Alend. The MFDS reviews the Alend KDMF as part of the drug registration process and uses the information provided in the Alend KDMF to evaluate the safety and efficacy of the drug.
After submitting a Alend 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 Alend API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Alend suppliers with KDMF on PharmaCompass.
A Alend CEP of the European Pharmacopoeia monograph is often referred to as a Alend Certificate of Suitability (COS). The purpose of a Alend CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Alend EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Alend to their clients by showing that a Alend CEP has been issued for it. The manufacturer submits a Alend CEP (COS) as part of the market authorization procedure, and it takes on the role of a Alend CEP holder for the record. Additionally, the data presented in the Alend CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Alend DMF.
A Alend CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Alend 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 Alend suppliers with CEP (COS) on PharmaCompass.
A Alend written confirmation (Alend WC) is an official document issued by a regulatory agency to a Alend manufacturer, verifying that the manufacturing facility of a Alend active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Alend APIs or Alend finished pharmaceutical products to another nation, regulatory agencies frequently require a Alend WC (written confirmation) as part of the regulatory process.
click here to find a list of Alend 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 Alend as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Alend 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 Alend 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 Alend and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Alend NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Alend suppliers with NDC on PharmaCompass.
Alend 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 Alend 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 Alend GMP manufacturer or Alend GMP API supplier for your needs.
A Alend CoA (Certificate of Analysis) is a formal document that attests to Alend's compliance with Alend specifications and serves as a tool for batch-level quality control.
Alend CoA mostly includes findings from lab analyses of a specific batch. For each Alend 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.
Alend may be tested according to a variety of international standards, such as European Pharmacopoeia (Alend EP), Alend JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Alend USP).
