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API SUPPLIERS
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USDMF
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INTERMEDIATE SUPPLIERS
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.
CAS Number : 2128-93-0
End Use API : Bifonazole
About The Company : Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics and ne...
ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.
CAS Number : 7598-80-3
End Use API : Bifonazole
About The Company : Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics and ne...
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PharmaCompass offers a list of Bifonazole 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 Bifonazole manufacturer or Bifonazole supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bifonazole manufacturer or Bifonazole supplier.
PharmaCompass also assists you with knowing the Bifonazole API Price utilized in the formulation of products. Bifonazole API Price is not always fixed or binding as the Bifonazole Price is obtained through a variety of data sources. The Bifonazole Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Bifomyk manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bifomyk, including repackagers and relabelers. The FDA regulates Bifomyk manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bifomyk 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 Bifomyk manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bifomyk supplier is an individual or a company that provides Bifomyk active pharmaceutical ingredient (API) or Bifomyk finished formulations upon request. The Bifomyk suppliers may include Bifomyk API manufacturers, exporters, distributors and traders.
click here to find a list of Bifomyk suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bifomyk DMF (Drug Master File) is a document detailing the whole manufacturing process of Bifomyk active pharmaceutical ingredient (API) in detail. Different forms of Bifomyk DMFs exist exist since differing nations have different regulations, such as Bifomyk USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bifomyk DMF submitted to regulatory agencies in the US is known as a USDMF. Bifomyk USDMF includes data on Bifomyk's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bifomyk USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bifomyk 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 Bifomyk Drug Master File in Japan (Bifomyk JDMF) empowers Bifomyk 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 Bifomyk JDMF during the approval evaluation for pharmaceutical products. At the time of Bifomyk 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 Bifomyk suppliers with JDMF on PharmaCompass.
A Bifomyk CEP of the European Pharmacopoeia monograph is often referred to as a Bifomyk Certificate of Suitability (COS). The purpose of a Bifomyk CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Bifomyk EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Bifomyk to their clients by showing that a Bifomyk CEP has been issued for it. The manufacturer submits a Bifomyk CEP (COS) as part of the market authorization procedure, and it takes on the role of a Bifomyk CEP holder for the record. Additionally, the data presented in the Bifomyk CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Bifomyk DMF.
A Bifomyk CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Bifomyk 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 Bifomyk suppliers with CEP (COS) on PharmaCompass.
A Bifomyk written confirmation (Bifomyk WC) is an official document issued by a regulatory agency to a Bifomyk manufacturer, verifying that the manufacturing facility of a Bifomyk active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bifomyk APIs or Bifomyk finished pharmaceutical products to another nation, regulatory agencies frequently require a Bifomyk WC (written confirmation) as part of the regulatory process.
click here to find a list of Bifomyk suppliers with Written Confirmation (WC) on PharmaCompass.
Bifomyk 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 Bifomyk 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 Bifomyk GMP manufacturer or Bifomyk GMP API supplier for your needs.
A Bifomyk CoA (Certificate of Analysis) is a formal document that attests to Bifomyk's compliance with Bifomyk specifications and serves as a tool for batch-level quality control.
Bifomyk CoA mostly includes findings from lab analyses of a specific batch. For each Bifomyk 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.
Bifomyk may be tested according to a variety of international standards, such as European Pharmacopoeia (Bifomyk EP), Bifomyk JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bifomyk USP).
