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