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**Federa...DOSAGE - TABLET;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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**Federa...DOSAGE - TABLET;ORAL - EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- INJECTABLE;INTRAVENOUS - EQ 3MG BASE/3ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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