US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Chloroprocaine HCl 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 Chloroprocaine HCl manufacturer or Chloroprocaine HCl supplier for your needs.
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PharmaCompass also assists you with knowing the Chloroprocaine HCl API Price utilized in the formulation of products. Chloroprocaine HCl API Price is not always fixed or binding as the Chloroprocaine HCl Price is obtained through a variety of data sources. The Chloroprocaine HCl Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Chloroprocaine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chloroprocaine Hydrochloride, including repackagers and relabelers. The FDA regulates Chloroprocaine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chloroprocaine Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Chloroprocaine Hydrochloride supplier is an individual or a company that provides Chloroprocaine Hydrochloride active pharmaceutical ingredient (API) or Chloroprocaine Hydrochloride finished formulations upon request. The Chloroprocaine Hydrochloride suppliers may include Chloroprocaine Hydrochloride API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Chloroprocaine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chloroprocaine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Chloroprocaine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Chloroprocaine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Chloroprocaine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chloroprocaine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Chloroprocaine Hydrochloride USDMF includes data on Chloroprocaine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chloroprocaine Hydrochloride 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 Chloroprocaine Hydrochloride Drug Master File in Japan (Chloroprocaine Hydrochloride JDMF) empowers Chloroprocaine Hydrochloride 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 Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Chloroprocaine Hydrochloride 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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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 Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Chloroprocaine Hydrochloride 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 Hydrochloride 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 Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Chloroprocaine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
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Chloroprocaine Hydrochloride 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 Hydrochloride 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 Hydrochloride GMP manufacturer or Chloroprocaine Hydrochloride GMP API supplier for your needs.
A Chloroprocaine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Chloroprocaine Hydrochloride's compliance with Chloroprocaine Hydrochloride specifications and serves as a tool for batch-level quality control.
Chloroprocaine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Chloroprocaine Hydrochloride 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 Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Chloroprocaine Hydrochloride EP), Chloroprocaine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Chloroprocaine Hydrochloride USP).