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DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21455
DOSAGE - TABLET;ORAL - EQ 2.5MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21455
DOSAGE - INJECTABLE;INTRAVENOUS - EQ 3MG BASE...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21858
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REF. STANDARDS & IMPURITIES
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PharmaCompass offers a list of Ibandronate 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 Ibandronate Sodium manufacturer or Ibandronate Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ibandronate Sodium manufacturer or Ibandronate Sodium supplier.
PharmaCompass also assists you with knowing the Ibandronate Sodium API Price utilized in the formulation of products. Ibandronate Sodium API Price is not always fixed or binding as the Ibandronate Sodium Price is obtained through a variety of data sources. The Ibandronate Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ibandronic acid Na salt manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ibandronic acid Na salt, including repackagers and relabelers. The FDA regulates Ibandronic acid Na salt manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ibandronic acid Na salt 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 Ibandronic acid Na salt manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ibandronic acid Na salt supplier is an individual or a company that provides Ibandronic acid Na salt active pharmaceutical ingredient (API) or Ibandronic acid Na salt finished formulations upon request. The Ibandronic acid Na salt suppliers may include Ibandronic acid Na salt API manufacturers, exporters, distributors and traders.
click here to find a list of Ibandronic acid Na salt suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ibandronic acid Na salt DMF (Drug Master File) is a document detailing the whole manufacturing process of Ibandronic acid Na salt active pharmaceutical ingredient (API) in detail. Different forms of Ibandronic acid Na salt DMFs exist exist since differing nations have different regulations, such as Ibandronic acid Na salt USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ibandronic acid Na salt DMF submitted to regulatory agencies in the US is known as a USDMF. Ibandronic acid Na salt USDMF includes data on Ibandronic acid Na salt's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ibandronic acid Na salt USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ibandronic acid Na salt 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 Ibandronic acid Na salt Drug Master File in Japan (Ibandronic acid Na salt JDMF) empowers Ibandronic acid Na salt 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 Ibandronic acid Na salt JDMF during the approval evaluation for pharmaceutical products. At the time of Ibandronic acid Na salt 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 Ibandronic acid Na salt 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 Ibandronic acid Na salt Drug Master File in Korea (Ibandronic acid Na salt KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ibandronic acid Na salt. The MFDS reviews the Ibandronic acid Na salt KDMF as part of the drug registration process and uses the information provided in the Ibandronic acid Na salt KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ibandronic acid Na salt 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 Ibandronic acid Na salt API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ibandronic acid Na salt suppliers with KDMF on PharmaCompass.
A Ibandronic acid Na salt CEP of the European Pharmacopoeia monograph is often referred to as a Ibandronic acid Na salt Certificate of Suitability (COS). The purpose of a Ibandronic acid Na salt CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ibandronic acid Na salt EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ibandronic acid Na salt to their clients by showing that a Ibandronic acid Na salt CEP has been issued for it. The manufacturer submits a Ibandronic acid Na salt CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ibandronic acid Na salt CEP holder for the record. Additionally, the data presented in the Ibandronic acid Na salt CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ibandronic acid Na salt DMF.
A Ibandronic acid Na salt CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ibandronic acid Na salt 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 Ibandronic acid Na salt suppliers with CEP (COS) on PharmaCompass.
A Ibandronic acid Na salt written confirmation (Ibandronic acid Na salt WC) is an official document issued by a regulatory agency to a Ibandronic acid Na salt manufacturer, verifying that the manufacturing facility of a Ibandronic acid Na salt active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ibandronic acid Na salt APIs or Ibandronic acid Na salt finished pharmaceutical products to another nation, regulatory agencies frequently require a Ibandronic acid Na salt WC (written confirmation) as part of the regulatory process.
click here to find a list of Ibandronic acid Na salt 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 Ibandronic acid Na salt as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ibandronic acid Na salt 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 Ibandronic acid Na salt 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 Ibandronic acid Na salt and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ibandronic acid Na salt NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ibandronic acid Na salt suppliers with NDC on PharmaCompass.
Ibandronic acid Na salt 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 Ibandronic acid Na salt 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 Ibandronic acid Na salt GMP manufacturer or Ibandronic acid Na salt GMP API supplier for your needs.
A Ibandronic acid Na salt CoA (Certificate of Analysis) is a formal document that attests to Ibandronic acid Na salt's compliance with Ibandronic acid Na salt specifications and serves as a tool for batch-level quality control.
Ibandronic acid Na salt CoA mostly includes findings from lab analyses of a specific batch. For each Ibandronic acid Na salt 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.
Ibandronic acid Na salt may be tested according to a variety of international standards, such as European Pharmacopoeia (Ibandronic acid Na salt EP), Ibandronic acid Na salt JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ibandronic acid Na salt USP).
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