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API SUPPLIERS
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USDMF
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DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25...DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML)
USFDA APPLICATION NUMBER - 205580
DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25...DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML)
USFDA APPLICATION NUMBER - 208194
DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25...DOSAGE - SOLUTION;INTRAVENOUS - 100MG/4ML (25MG/ML)
USFDA APPLICATION NUMBER - 215033
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Bendamustine 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 Bendamustine manufacturer or Bendamustine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bendamustine manufacturer or Bendamustine supplier.
PharmaCompass also assists you with knowing the Bendamustine API Price utilized in the formulation of products. Bendamustine API Price is not always fixed or binding as the Bendamustine Price is obtained through a variety of data sources. The Bendamustine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A BENDAMUSTINE HCL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BENDAMUSTINE HCL, including repackagers and relabelers. The FDA regulates BENDAMUSTINE HCL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BENDAMUSTINE HCL 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 BENDAMUSTINE HCL manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A BENDAMUSTINE HCL supplier is an individual or a company that provides BENDAMUSTINE HCL active pharmaceutical ingredient (API) or BENDAMUSTINE HCL finished formulations upon request. The BENDAMUSTINE HCL suppliers may include BENDAMUSTINE HCL API manufacturers, exporters, distributors and traders.
click here to find a list of BENDAMUSTINE HCL suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A BENDAMUSTINE HCL DMF (Drug Master File) is a document detailing the whole manufacturing process of BENDAMUSTINE HCL active pharmaceutical ingredient (API) in detail. Different forms of BENDAMUSTINE HCL DMFs exist exist since differing nations have different regulations, such as BENDAMUSTINE HCL USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A BENDAMUSTINE HCL DMF submitted to regulatory agencies in the US is known as a USDMF. BENDAMUSTINE HCL USDMF includes data on BENDAMUSTINE HCL's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The BENDAMUSTINE HCL USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of BENDAMUSTINE HCL 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 BENDAMUSTINE HCL Drug Master File in Japan (BENDAMUSTINE HCL JDMF) empowers BENDAMUSTINE HCL 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 BENDAMUSTINE HCL JDMF during the approval evaluation for pharmaceutical products. At the time of BENDAMUSTINE HCL 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 BENDAMUSTINE HCL 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 BENDAMUSTINE HCL Drug Master File in Korea (BENDAMUSTINE HCL KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of BENDAMUSTINE HCL. The MFDS reviews the BENDAMUSTINE HCL KDMF as part of the drug registration process and uses the information provided in the BENDAMUSTINE HCL KDMF to evaluate the safety and efficacy of the drug.
After submitting a BENDAMUSTINE HCL 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 BENDAMUSTINE HCL API can apply through the Korea Drug Master File (KDMF).
click here to find a list of BENDAMUSTINE HCL suppliers with KDMF on PharmaCompass.
A BENDAMUSTINE HCL written confirmation (BENDAMUSTINE HCL WC) is an official document issued by a regulatory agency to a BENDAMUSTINE HCL manufacturer, verifying that the manufacturing facility of a BENDAMUSTINE HCL active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting BENDAMUSTINE HCL APIs or BENDAMUSTINE HCL finished pharmaceutical products to another nation, regulatory agencies frequently require a BENDAMUSTINE HCL WC (written confirmation) as part of the regulatory process.
click here to find a list of BENDAMUSTINE HCL 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 BENDAMUSTINE HCL as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for BENDAMUSTINE HCL 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 BENDAMUSTINE HCL 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 BENDAMUSTINE HCL and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a BENDAMUSTINE HCL NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of BENDAMUSTINE HCL suppliers with NDC on PharmaCompass.
BENDAMUSTINE HCL 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 BENDAMUSTINE HCL 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 BENDAMUSTINE HCL GMP manufacturer or BENDAMUSTINE HCL GMP API supplier for your needs.
A BENDAMUSTINE HCL CoA (Certificate of Analysis) is a formal document that attests to BENDAMUSTINE HCL's compliance with BENDAMUSTINE HCL specifications and serves as a tool for batch-level quality control.
BENDAMUSTINE HCL CoA mostly includes findings from lab analyses of a specific batch. For each BENDAMUSTINE HCL 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.
BENDAMUSTINE HCL may be tested according to a variety of international standards, such as European Pharmacopoeia (BENDAMUSTINE HCL EP), BENDAMUSTINE HCL JP (Japanese Pharmacopeia) and the US Pharmacopoeia (BENDAMUSTINE HCL USP).
