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CEP/COS
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EU WC
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KDMF
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VMF
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FDF
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Europe
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Canada
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Australia
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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - SOLUTION;INTRATHECAL - 50MG/5ML (10M...DOSAGE - SOLUTION;INTRATHECAL - 50MG/5ML (10MG/ML)
USFDA APPLICATION NUMBER - 208791
DOSAGE - INJECTABLE;INJECTION - 1%
USFDA APPLICATION NUMBER - 9435
DOSAGE - INJECTABLE;INJECTION - 2%
USFDA APPLICATION NUMBER - 9435
DOSAGE - INJECTABLE;INJECTION - 3%
USFDA APPLICATION NUMBER - 9435
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03 Jan 2020
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Chloroprocaine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chloroprocaine HCl, including repackagers and relabelers. The FDA regulates Chloroprocaine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chloroprocaine 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 Chloroprocaine HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Chloroprocaine HCl supplier is an individual or a company that provides Chloroprocaine HCl active pharmaceutical ingredient (API) or Chloroprocaine HCl finished formulations upon request. The Chloroprocaine HCl suppliers may include Chloroprocaine HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Chloroprocaine HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chloroprocaine HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Chloroprocaine HCl active pharmaceutical ingredient (API) in detail. Different forms of Chloroprocaine HCl DMFs exist exist since differing nations have different regulations, such as Chloroprocaine HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chloroprocaine HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Chloroprocaine HCl USDMF includes data on Chloroprocaine HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chloroprocaine HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Chloroprocaine 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 Chloroprocaine HCl Drug Master File in Japan (Chloroprocaine HCl JDMF) empowers Chloroprocaine 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 Chloroprocaine HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Chloroprocaine 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 Chloroprocaine HCl suppliers with JDMF 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 Chloroprocaine HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Chloroprocaine 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 Chloroprocaine 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 Chloroprocaine HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Chloroprocaine HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Chloroprocaine HCl suppliers with NDC on PharmaCompass.
Chloroprocaine 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 Chloroprocaine 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 Chloroprocaine HCl GMP manufacturer or Chloroprocaine HCl GMP API supplier for your needs.
A Chloroprocaine HCl CoA (Certificate of Analysis) is a formal document that attests to Chloroprocaine HCl's compliance with Chloroprocaine HCl specifications and serves as a tool for batch-level quality control.
Chloroprocaine HCl CoA mostly includes findings from lab analyses of a specific batch. For each Chloroprocaine 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.
Chloroprocaine HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Chloroprocaine HCl EP), Chloroprocaine HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Chloroprocaine HCl USP).
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