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