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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Bendamustine Hydrochloride IH/USP
Date of Issue : 2025-07-15
Valid Till : 2028-07-07
Written Confirmation Number : WC-0067
Address of the Firm : Chemical Technical Operation
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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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PharmaCompass offers a list of Bendamustine Hydrochloride 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 Bendamustine Hydrochloride manufacturer or Bendamustine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bendamustine Hydrochloride manufacturer or Bendamustine Hydrochloride supplier.
A 1H-Benzimidazole-2-butanoic acid, monohydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1H-Benzimidazole-2-butanoic acid, monohydrochloride, including repackagers and relabelers. The FDA regulates 1H-Benzimidazole-2-butanoic acid, monohydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1H-Benzimidazole-2-butanoic acid, monohydrochloride 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 1H-Benzimidazole-2-butanoic acid, monohydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A 1H-Benzimidazole-2-butanoic acid, monohydrochloride supplier is an individual or a company that provides 1H-Benzimidazole-2-butanoic acid, monohydrochloride active pharmaceutical ingredient (API) or 1H-Benzimidazole-2-butanoic acid, monohydrochloride finished formulations upon request. The 1H-Benzimidazole-2-butanoic acid, monohydrochloride suppliers may include 1H-Benzimidazole-2-butanoic acid, monohydrochloride API manufacturers, exporters, distributors and traders.
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A 1H-Benzimidazole-2-butanoic acid, monohydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of 1H-Benzimidazole-2-butanoic acid, monohydrochloride active pharmaceutical ingredient (API) in detail. Different forms of 1H-Benzimidazole-2-butanoic acid, monohydrochloride DMFs exist exist since differing nations have different regulations, such as 1H-Benzimidazole-2-butanoic acid, monohydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 1H-Benzimidazole-2-butanoic acid, monohydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. 1H-Benzimidazole-2-butanoic acid, monohydrochloride USDMF includes data on 1H-Benzimidazole-2-butanoic acid, monohydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1H-Benzimidazole-2-butanoic acid, monohydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 1H-Benzimidazole-2-butanoic acid, monohydrochloride Drug Master File in Japan (1H-Benzimidazole-2-butanoic acid, monohydrochloride JDMF) empowers 1H-Benzimidazole-2-butanoic acid, monohydrochloride 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 1H-Benzimidazole-2-butanoic acid, monohydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of 1H-Benzimidazole-2-butanoic acid, monohydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 1H-Benzimidazole-2-butanoic acid, monohydrochloride Drug Master File in Korea (1H-Benzimidazole-2-butanoic acid, monohydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 1H-Benzimidazole-2-butanoic acid, monohydrochloride. The MFDS reviews the 1H-Benzimidazole-2-butanoic acid, monohydrochloride KDMF as part of the drug registration process and uses the information provided in the 1H-Benzimidazole-2-butanoic acid, monohydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a 1H-Benzimidazole-2-butanoic acid, monohydrochloride 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 1H-Benzimidazole-2-butanoic acid, monohydrochloride API can apply through the Korea Drug Master File (KDMF).
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A 1H-Benzimidazole-2-butanoic acid, monohydrochloride written confirmation (1H-Benzimidazole-2-butanoic acid, monohydrochloride WC) is an official document issued by a regulatory agency to a 1H-Benzimidazole-2-butanoic acid, monohydrochloride manufacturer, verifying that the manufacturing facility of a 1H-Benzimidazole-2-butanoic acid, monohydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 1H-Benzimidazole-2-butanoic acid, monohydrochloride APIs or 1H-Benzimidazole-2-butanoic acid, monohydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a 1H-Benzimidazole-2-butanoic acid, monohydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of 1H-Benzimidazole-2-butanoic acid, monohydrochloride 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 1H-Benzimidazole-2-butanoic acid, monohydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 1H-Benzimidazole-2-butanoic acid, monohydrochloride 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 1H-Benzimidazole-2-butanoic acid, monohydrochloride 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 1H-Benzimidazole-2-butanoic acid, monohydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 1H-Benzimidazole-2-butanoic acid, monohydrochloride NDC to their finished compounded human drug products, they may choose to do so.
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1H-Benzimidazole-2-butanoic acid, monohydrochloride 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 1H-Benzimidazole-2-butanoic acid, monohydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right 1H-Benzimidazole-2-butanoic acid, monohydrochloride GMP manufacturer or 1H-Benzimidazole-2-butanoic acid, monohydrochloride GMP API supplier for your needs.
A 1H-Benzimidazole-2-butanoic acid, monohydrochloride CoA (Certificate of Analysis) is a formal document that attests to 1H-Benzimidazole-2-butanoic acid, monohydrochloride's compliance with 1H-Benzimidazole-2-butanoic acid, monohydrochloride specifications and serves as a tool for batch-level quality control.
1H-Benzimidazole-2-butanoic acid, monohydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each 1H-Benzimidazole-2-butanoic acid, monohydrochloride 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.
1H-Benzimidazole-2-butanoic acid, monohydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (1H-Benzimidazole-2-butanoic acid, monohydrochloride EP), 1H-Benzimidazole-2-butanoic acid, monohydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (1H-Benzimidazole-2-butanoic acid, monohydrochloride USP).
