US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Paracetamol 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 Paracetamol manufacturer or Paracetamol supplier for your needs.
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PharmaCompass also assists you with knowing the Paracetamol API Price utilized in the formulation of products. Paracetamol API Price is not always fixed or binding as the Paracetamol Price is obtained through a variety of data sources. The Paracetamol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Acetaminophen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acetaminophen, including repackagers and relabelers. The FDA regulates Acetaminophen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acetaminophen 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 Acetaminophen supplier is an individual or a company that provides Acetaminophen active pharmaceutical ingredient (API) or Acetaminophen finished formulations upon request. The Acetaminophen suppliers may include Acetaminophen API manufacturers, exporters, distributors and traders.
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A Acetaminophen DMF (Drug Master File) is a document detailing the whole manufacturing process of Acetaminophen active pharmaceutical ingredient (API) in detail. Different forms of Acetaminophen DMFs exist exist since differing nations have different regulations, such as Acetaminophen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Acetaminophen DMF submitted to regulatory agencies in the US is known as a USDMF. Acetaminophen USDMF includes data on Acetaminophen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acetaminophen 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 Acetaminophen Drug Master File in Japan (Acetaminophen JDMF) empowers Acetaminophen 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 Acetaminophen JDMF during the approval evaluation for pharmaceutical products. At the time of Acetaminophen 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 Acetaminophen Drug Master File in Korea (Acetaminophen KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Acetaminophen. The MFDS reviews the Acetaminophen KDMF as part of the drug registration process and uses the information provided in the Acetaminophen KDMF to evaluate the safety and efficacy of the drug.
After submitting a Acetaminophen 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 Acetaminophen API can apply through the Korea Drug Master File (KDMF).
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A Acetaminophen CEP of the European Pharmacopoeia monograph is often referred to as a Acetaminophen Certificate of Suitability (COS). The purpose of a Acetaminophen CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Acetaminophen EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Acetaminophen to their clients by showing that a Acetaminophen CEP has been issued for it. The manufacturer submits a Acetaminophen CEP (COS) as part of the market authorization procedure, and it takes on the role of a Acetaminophen CEP holder for the record. Additionally, the data presented in the Acetaminophen CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Acetaminophen DMF.
A Acetaminophen CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Acetaminophen CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Acetaminophen written confirmation (Acetaminophen WC) is an official document issued by a regulatory agency to a Acetaminophen manufacturer, verifying that the manufacturing facility of a Acetaminophen active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Acetaminophen APIs or Acetaminophen finished pharmaceutical products to another nation, regulatory agencies frequently require a Acetaminophen WC (written confirmation) as part of the regulatory process.
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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 Acetaminophen as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Acetaminophen 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 Acetaminophen 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 Acetaminophen and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Acetaminophen NDC to their finished compounded human drug products, they may choose to do so.
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Acetaminophen 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 Acetaminophen 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 Acetaminophen GMP manufacturer or Acetaminophen GMP API supplier for your needs.
A Acetaminophen CoA (Certificate of Analysis) is a formal document that attests to Acetaminophen's compliance with Acetaminophen specifications and serves as a tool for batch-level quality control.
Acetaminophen CoA mostly includes findings from lab analyses of a specific batch. For each Acetaminophen 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.
Acetaminophen may be tested according to a variety of international standards, such as European Pharmacopoeia (Acetaminophen EP), Acetaminophen JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Acetaminophen USP).