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