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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]DRUG PRODUCT COMPOSITIONS
DOSAGE - TABLET;ORAL - 150MG
USFDA APPLICATION NUMBER - 20835
DOSAGE - TABLET;ORAL - 30MG
USFDA APPLICATION NUMBER - 20835
DOSAGE - TABLET;ORAL - 35MG
USFDA APPLICATION NUMBER - 20835
DOSAGE - TABLET;ORAL - 5MG
USFDA APPLICATION NUMBER - 20835
DOSAGE - TABLET;ORAL - 75MG **Federal Registe...DOSAGE - TABLET;ORAL - 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20835
DOSAGE - TABLET, DELAYED RELEASE;ORAL - 35MG
USFDA APPLICATION NUMBER - 22560
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ABOUT THIS PAGE
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PharmaCompass offers a list of Risedronate 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 Risedronate Sodium manufacturer or Risedronate Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Risedronate Sodium manufacturer or Risedronate Sodium supplier.
PharmaCompass also assists you with knowing the Risedronate Sodium API Price utilized in the formulation of products. Risedronate Sodium API Price is not always fixed or binding as the Risedronate Sodium Price is obtained through a variety of data sources. The Risedronate Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Risedronate Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Risedronate Sodium, including repackagers and relabelers. The FDA regulates Risedronate Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Risedronate 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 Risedronate Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Risedronate Sodium supplier is an individual or a company that provides Risedronate Sodium active pharmaceutical ingredient (API) or Risedronate Sodium finished formulations upon request. The Risedronate Sodium suppliers may include Risedronate Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Risedronate Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Risedronate Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Risedronate Sodium active pharmaceutical ingredient (API) in detail. Different forms of Risedronate Sodium DMFs exist exist since differing nations have different regulations, such as Risedronate Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Risedronate Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Risedronate Sodium USDMF includes data on Risedronate Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Risedronate Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Risedronate Sodium 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 Risedronate Sodium Drug Master File in Japan (Risedronate Sodium JDMF) empowers Risedronate 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 Risedronate Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Risedronate Sodium 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 Risedronate Sodium 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 Risedronate Sodium Drug Master File in Korea (Risedronate Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Risedronate Sodium. The MFDS reviews the Risedronate Sodium KDMF as part of the drug registration process and uses the information provided in the Risedronate Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Risedronate 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 Risedronate Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Risedronate Sodium suppliers with KDMF on PharmaCompass.
A Risedronate Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Risedronate Sodium Certificate of Suitability (COS). The purpose of a Risedronate Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Risedronate Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Risedronate Sodium to their clients by showing that a Risedronate Sodium CEP has been issued for it. The manufacturer submits a Risedronate Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Risedronate Sodium CEP holder for the record. Additionally, the data presented in the Risedronate Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Risedronate Sodium DMF.
A Risedronate Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Risedronate Sodium 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 Risedronate Sodium suppliers with CEP (COS) on PharmaCompass.
A Risedronate Sodium written confirmation (Risedronate Sodium WC) is an official document issued by a regulatory agency to a Risedronate Sodium manufacturer, verifying that the manufacturing facility of a Risedronate Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Risedronate Sodium APIs or Risedronate Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Risedronate Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Risedronate Sodium 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 Risedronate Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Risedronate 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 Risedronate 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 Risedronate Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Risedronate Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Risedronate Sodium suppliers with NDC on PharmaCompass.
Risedronate 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 Risedronate 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 Risedronate Sodium GMP manufacturer or Risedronate Sodium GMP API supplier for your needs.
A Risedronate Sodium CoA (Certificate of Analysis) is a formal document that attests to Risedronate Sodium's compliance with Risedronate Sodium specifications and serves as a tool for batch-level quality control.
Risedronate Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Risedronate 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.
Risedronate Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Risedronate Sodium EP), Risedronate Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Risedronate Sodium USP).
