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  • TABLET;ORAL - 150MG
  • TABLET;ORAL - 30MG
  • TABLET;ORAL - 35MG
  • TABLET;ORAL - 5MG
  • TABLET;ORAL - 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, DELAYED RELEASE;ORAL - 35MG

Looking for 115436-72-1 / Risedronate Sodium API manufacturers, exporters & distributors?

Risedronate Sodium manufacturers, exporters & distributors 1

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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.

API | Excipient name

Risedronate Sodium

Synonyms

Sodium risedronate, 115436-72-1, Actonel, Atelvia, Risedronate (sodium), Ne 58095

Cas Number

115436-72-1

Unique Ingredient Identifier (UNII)

OFG5EXG60L

About Risedronate Sodium

A pyridine and diphosphonic acid derivative that acts as a CALCIUM CHANNEL BLOCKER and inhibits BONE RESORPTION.

Risedronic Acid Manufacturers

A Risedronic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Risedronic Acid, including repackagers and relabelers. The FDA regulates Risedronic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Risedronic 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 Risedronic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Risedronic Acid Suppliers

A Risedronic Acid supplier is an individual or a company that provides Risedronic Acid active pharmaceutical ingredient (API) or Risedronic Acid finished formulations upon request. The Risedronic Acid suppliers may include Risedronic Acid API manufacturers, exporters, distributors and traders.

click here to find a list of Risedronic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Risedronic Acid USDMF

A Risedronic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Risedronic Acid active pharmaceutical ingredient (API) in detail. Different forms of Risedronic Acid DMFs exist exist since differing nations have different regulations, such as Risedronic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Risedronic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Risedronic Acid USDMF includes data on Risedronic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Risedronic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Risedronic Acid suppliers with USDMF on PharmaCompass.

Risedronic Acid JDMF

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 Risedronic Acid Drug Master File in Japan (Risedronic Acid JDMF) empowers Risedronic 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 Risedronic Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Risedronic 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 Risedronic Acid suppliers with JDMF on PharmaCompass.

Risedronic Acid KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Risedronic Acid Drug Master File in Korea (Risedronic Acid KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Risedronic Acid. The MFDS reviews the Risedronic Acid KDMF as part of the drug registration process and uses the information provided in the Risedronic Acid KDMF to evaluate the safety and efficacy of the drug.

After submitting a Risedronic Acid 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 Risedronic Acid API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Risedronic Acid suppliers with KDMF on PharmaCompass.

Risedronic Acid CEP

A Risedronic Acid CEP of the European Pharmacopoeia monograph is often referred to as a Risedronic Acid Certificate of Suitability (COS). The purpose of a Risedronic Acid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Risedronic Acid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Risedronic Acid to their clients by showing that a Risedronic Acid CEP has been issued for it. The manufacturer submits a Risedronic Acid CEP (COS) as part of the market authorization procedure, and it takes on the role of a Risedronic Acid CEP holder for the record. Additionally, the data presented in the Risedronic Acid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Risedronic Acid DMF.

A Risedronic Acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Risedronic 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 Risedronic Acid suppliers with CEP (COS) on PharmaCompass.

Risedronic Acid WC

A Risedronic Acid written confirmation (Risedronic Acid WC) is an official document issued by a regulatory agency to a Risedronic Acid manufacturer, verifying that the manufacturing facility of a Risedronic Acid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Risedronic Acid APIs or Risedronic Acid finished pharmaceutical products to another nation, regulatory agencies frequently require a Risedronic Acid WC (written confirmation) as part of the regulatory process.

click here to find a list of Risedronic Acid suppliers with Written Confirmation (WC) on PharmaCompass.

Risedronic Acid NDC

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 Risedronic Acid as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Risedronic Acid API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Risedronic 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Risedronic Acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Risedronic Acid NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Risedronic Acid suppliers with NDC on PharmaCompass.

Risedronic Acid GMP

Risedronic 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 Risedronic 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 Risedronic Acid GMP manufacturer or Risedronic Acid GMP API supplier for your needs.

Risedronic Acid CoA

A Risedronic Acid CoA (Certificate of Analysis) is a formal document that attests to Risedronic Acid's compliance with Risedronic Acid specifications and serves as a tool for batch-level quality control.

Risedronic Acid CoA mostly includes findings from lab analyses of a specific batch. For each Risedronic 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.

Risedronic Acid may be tested according to a variety of international standards, such as European Pharmacopoeia (Risedronic Acid EP), Risedronic Acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Risedronic Acid USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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