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