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API SUPPLIERS
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USDMF
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies 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
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20494
Submission : 2007-04-30
Status :
Type : II
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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Ibandronate Sodium Monohydrate, Type I
Certificate Number : R0-CEP 2023-077 - Rev 00
Status : Valid
Issue Date : 2023-06-30
Type : Chemical
Substance Number : 2771
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Ibandronate Sodium Monohydrate
Certificate Number : R0-CEP 2022-073 - Rev 00
Status : Valid
Issue Date : 2023-02-20
Type : Chemical
Substance Number : 2771
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
About the Company : Laboratorium Ofichem is a GMP-certified and FDA-approved API manufacturer with state-of-the-art development and production facilities in the Netherlands. We develop and manufacture...
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
About the Company : Pharmathen, established in 1969, has emerged as a leading in-house development partner in Europe. It specializes in the development, registration, manufacturing & life-cycle manage...
JPN Pharma offers excellence in API manufacturing through precision, innovation & quality, delivering solutions to the pharma industry
About the Company : JPN Pharma is a premier pharmaceutical company in India, specializing in the development and manufacturing of Active Pharmaceutical Ingredients (APIs) and drug intermediates. Headq...
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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, 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 Boniva manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Boniva, including repackagers and relabelers. The FDA regulates Boniva manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Boniva 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 Boniva manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Boniva supplier is an individual or a company that provides Boniva active pharmaceutical ingredient (API) or Boniva finished formulations upon request. The Boniva suppliers may include Boniva API manufacturers, exporters, distributors and traders.
click here to find a list of Boniva suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Boniva DMF (Drug Master File) is a document detailing the whole manufacturing process of Boniva active pharmaceutical ingredient (API) in detail. Different forms of Boniva DMFs exist exist since differing nations have different regulations, such as Boniva USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Boniva DMF submitted to regulatory agencies in the US is known as a USDMF. Boniva USDMF includes data on Boniva's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Boniva USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Boniva 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 Boniva Drug Master File in Japan (Boniva JDMF) empowers Boniva 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 Boniva JDMF during the approval evaluation for pharmaceutical products. At the time of Boniva 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 Boniva 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 Boniva Drug Master File in Korea (Boniva KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Boniva. The MFDS reviews the Boniva KDMF as part of the drug registration process and uses the information provided in the Boniva KDMF to evaluate the safety and efficacy of the drug.
After submitting a Boniva 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 Boniva API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Boniva suppliers with KDMF on PharmaCompass.
A Boniva CEP of the European Pharmacopoeia monograph is often referred to as a Boniva Certificate of Suitability (COS). The purpose of a Boniva CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Boniva EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Boniva to their clients by showing that a Boniva CEP has been issued for it. The manufacturer submits a Boniva CEP (COS) as part of the market authorization procedure, and it takes on the role of a Boniva CEP holder for the record. Additionally, the data presented in the Boniva CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Boniva DMF.
A Boniva CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Boniva 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 Boniva suppliers with CEP (COS) on PharmaCompass.
A Boniva written confirmation (Boniva WC) is an official document issued by a regulatory agency to a Boniva manufacturer, verifying that the manufacturing facility of a Boniva active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Boniva APIs or Boniva finished pharmaceutical products to another nation, regulatory agencies frequently require a Boniva WC (written confirmation) as part of the regulatory process.
click here to find a list of Boniva 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 Boniva as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Boniva 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 Boniva 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 Boniva and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Boniva NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Boniva suppliers with NDC on PharmaCompass.
Boniva 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 Boniva 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 Boniva GMP manufacturer or Boniva GMP API supplier for your needs.
A Boniva CoA (Certificate of Analysis) is a formal document that attests to Boniva's compliance with Boniva specifications and serves as a tool for batch-level quality control.
Boniva CoA mostly includes findings from lab analyses of a specific batch. For each Boniva 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.
Boniva may be tested according to a variety of international standards, such as European Pharmacopoeia (Boniva EP), Boniva JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Boniva USP).
