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NanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.
Regulatory Info :
Registration Country : Iran
Brand Name : Leudribine
Dosage Form : Vial
Dosage Strength : 10MG/10ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
NanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.
Regulatory Info :
Registration Country : Iran
Brand Name : Leudribine
Dosage Form : Vial
Dosage Strength : 10MG/5ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
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12 Nov 2020
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PharmaCompass offers a list of Cladribine 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 Cladribine manufacturer or Cladribine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cladribine manufacturer or Cladribine supplier.
PharmaCompass also assists you with knowing the Cladribine API Price utilized in the formulation of products. Cladribine API Price is not always fixed or binding as the Cladribine Price is obtained through a variety of data sources. The Cladribine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A C10H12ClN5O3.C3H8 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of C10H12ClN5O3.C3H8, including repackagers and relabelers. The FDA regulates C10H12ClN5O3.C3H8 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. C10H12ClN5O3.C3H8 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 C10H12ClN5O3.C3H8 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A C10H12ClN5O3.C3H8 supplier is an individual or a company that provides C10H12ClN5O3.C3H8 active pharmaceutical ingredient (API) or C10H12ClN5O3.C3H8 finished formulations upon request. The C10H12ClN5O3.C3H8 suppliers may include C10H12ClN5O3.C3H8 API manufacturers, exporters, distributors and traders.
click here to find a list of C10H12ClN5O3.C3H8 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A C10H12ClN5O3.C3H8 DMF (Drug Master File) is a document detailing the whole manufacturing process of C10H12ClN5O3.C3H8 active pharmaceutical ingredient (API) in detail. Different forms of C10H12ClN5O3.C3H8 DMFs exist exist since differing nations have different regulations, such as C10H12ClN5O3.C3H8 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A C10H12ClN5O3.C3H8 DMF submitted to regulatory agencies in the US is known as a USDMF. C10H12ClN5O3.C3H8 USDMF includes data on C10H12ClN5O3.C3H8's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The C10H12ClN5O3.C3H8 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of C10H12ClN5O3.C3H8 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 C10H12ClN5O3.C3H8 Drug Master File in Japan (C10H12ClN5O3.C3H8 JDMF) empowers C10H12ClN5O3.C3H8 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 C10H12ClN5O3.C3H8 JDMF during the approval evaluation for pharmaceutical products. At the time of C10H12ClN5O3.C3H8 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 C10H12ClN5O3.C3H8 suppliers with JDMF on PharmaCompass.
A C10H12ClN5O3.C3H8 CEP of the European Pharmacopoeia monograph is often referred to as a C10H12ClN5O3.C3H8 Certificate of Suitability (COS). The purpose of a C10H12ClN5O3.C3H8 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of C10H12ClN5O3.C3H8 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of C10H12ClN5O3.C3H8 to their clients by showing that a C10H12ClN5O3.C3H8 CEP has been issued for it. The manufacturer submits a C10H12ClN5O3.C3H8 CEP (COS) as part of the market authorization procedure, and it takes on the role of a C10H12ClN5O3.C3H8 CEP holder for the record. Additionally, the data presented in the C10H12ClN5O3.C3H8 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the C10H12ClN5O3.C3H8 DMF.
A C10H12ClN5O3.C3H8 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. C10H12ClN5O3.C3H8 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 C10H12ClN5O3.C3H8 suppliers with CEP (COS) on PharmaCompass.
A C10H12ClN5O3.C3H8 written confirmation (C10H12ClN5O3.C3H8 WC) is an official document issued by a regulatory agency to a C10H12ClN5O3.C3H8 manufacturer, verifying that the manufacturing facility of a C10H12ClN5O3.C3H8 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting C10H12ClN5O3.C3H8 APIs or C10H12ClN5O3.C3H8 finished pharmaceutical products to another nation, regulatory agencies frequently require a C10H12ClN5O3.C3H8 WC (written confirmation) as part of the regulatory process.
click here to find a list of C10H12ClN5O3.C3H8 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 C10H12ClN5O3.C3H8 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for C10H12ClN5O3.C3H8 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 C10H12ClN5O3.C3H8 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 C10H12ClN5O3.C3H8 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a C10H12ClN5O3.C3H8 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of C10H12ClN5O3.C3H8 suppliers with NDC on PharmaCompass.
C10H12ClN5O3.C3H8 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 C10H12ClN5O3.C3H8 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 C10H12ClN5O3.C3H8 GMP manufacturer or C10H12ClN5O3.C3H8 GMP API supplier for your needs.
A C10H12ClN5O3.C3H8 CoA (Certificate of Analysis) is a formal document that attests to C10H12ClN5O3.C3H8's compliance with C10H12ClN5O3.C3H8 specifications and serves as a tool for batch-level quality control.
C10H12ClN5O3.C3H8 CoA mostly includes findings from lab analyses of a specific batch. For each C10H12ClN5O3.C3H8 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.
C10H12ClN5O3.C3H8 may be tested according to a variety of international standards, such as European Pharmacopoeia (C10H12ClN5O3.C3H8 EP), C10H12ClN5O3.C3H8 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (C10H12ClN5O3.C3H8 USP).
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