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API SUPPLIERS
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USDMF
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
GDUFA
DMF Review : Complete
Rev. Date : 2016-12-12
Pay. Date : 2016-06-21
DMF Number : 25638
Submission : 2011-12-29
Status :
Type : II
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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**Federa...DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federa...DOSAGE - TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- INJECTABLE;INTRAVENOUS - EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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ABOUT THIS PAGE
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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, 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.
A Ibandronate sodium salt manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ibandronate sodium salt, including repackagers and relabelers. The FDA regulates Ibandronate sodium salt manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ibandronate sodium 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 Ibandronate sodium salt manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ibandronate sodium salt supplier is an individual or a company that provides Ibandronate sodium salt active pharmaceutical ingredient (API) or Ibandronate sodium salt finished formulations upon request. The Ibandronate sodium salt suppliers may include Ibandronate sodium salt API manufacturers, exporters, distributors and traders.
click here to find a list of Ibandronate sodium salt suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Ibandronate sodium salt DMF (Drug Master File) is a document detailing the whole manufacturing process of Ibandronate sodium salt active pharmaceutical ingredient (API) in detail. Different forms of Ibandronate sodium salt DMFs exist exist since differing nations have different regulations, such as Ibandronate sodium salt USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ibandronate sodium salt DMF submitted to regulatory agencies in the US is known as a USDMF. Ibandronate sodium salt USDMF includes data on Ibandronate sodium salt's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ibandronate sodium salt USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ibandronate sodium 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 Ibandronate sodium salt Drug Master File in Japan (Ibandronate sodium salt JDMF) empowers Ibandronate sodium 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 Ibandronate sodium salt JDMF during the approval evaluation for pharmaceutical products. At the time of Ibandronate sodium 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 Ibandronate sodium 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 Ibandronate sodium salt Drug Master File in Korea (Ibandronate sodium salt KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ibandronate sodium salt. The MFDS reviews the Ibandronate sodium salt KDMF as part of the drug registration process and uses the information provided in the Ibandronate sodium salt KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ibandronate sodium 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 Ibandronate sodium salt API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ibandronate sodium salt suppliers with KDMF on PharmaCompass.
A Ibandronate sodium salt CEP of the European Pharmacopoeia monograph is often referred to as a Ibandronate sodium salt Certificate of Suitability (COS). The purpose of a Ibandronate sodium salt CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ibandronate sodium salt EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ibandronate sodium salt to their clients by showing that a Ibandronate sodium salt CEP has been issued for it. The manufacturer submits a Ibandronate sodium salt CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ibandronate sodium salt CEP holder for the record. Additionally, the data presented in the Ibandronate sodium salt CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ibandronate sodium salt DMF.
A Ibandronate sodium salt CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ibandronate sodium 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 Ibandronate sodium salt suppliers with CEP (COS) on PharmaCompass.
A Ibandronate sodium salt written confirmation (Ibandronate sodium salt WC) is an official document issued by a regulatory agency to a Ibandronate sodium salt manufacturer, verifying that the manufacturing facility of a Ibandronate sodium salt active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ibandronate sodium salt APIs or Ibandronate sodium salt finished pharmaceutical products to another nation, regulatory agencies frequently require a Ibandronate sodium salt WC (written confirmation) as part of the regulatory process.
click here to find a list of Ibandronate sodium 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 Ibandronate sodium salt as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ibandronate sodium 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 Ibandronate sodium 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 Ibandronate sodium salt and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ibandronate sodium salt NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ibandronate sodium salt suppliers with NDC on PharmaCompass.
Ibandronate sodium 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 Ibandronate sodium salt GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ibandronate sodium salt GMP manufacturer or Ibandronate sodium salt GMP API supplier for your needs.
A Ibandronate sodium salt CoA (Certificate of Analysis) is a formal document that attests to Ibandronate sodium salt's compliance with Ibandronate sodium salt specifications and serves as a tool for batch-level quality control.
Ibandronate sodium salt CoA mostly includes findings from lab analyses of a specific batch. For each Ibandronate sodium 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.
Ibandronate sodium salt may be tested according to a variety of international standards, such as European Pharmacopoeia (Ibandronate sodium salt EP), Ibandronate sodium salt JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ibandronate sodium salt USP).
