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CEP/COS
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KDMF
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API SUPPLIERS
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INTERMEDIATES SUPPLIERS
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Seqens
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Topical
Solubilizers
Thickeners and Stabilizers
Controlled & Modified Release
Parenteral
Taste Masking
Film Formers & Plasticizers
Granulation
Coating Systems & Additives
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Butamben manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Butamben, including repackagers and relabelers. The FDA regulates Butamben manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Butamben 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 Butamben manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Butamben supplier is an individual or a company that provides Butamben active pharmaceutical ingredient (API) or Butamben finished formulations upon request. The Butamben suppliers may include Butamben API manufacturers, exporters, distributors and traders.
click here to find a list of Butamben suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Butamben DMF (Drug Master File) is a document detailing the whole manufacturing process of Butamben active pharmaceutical ingredient (API) in detail. Different forms of Butamben DMFs exist exist since differing nations have different regulations, such as Butamben USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Butamben DMF submitted to regulatory agencies in the US is known as a USDMF. Butamben USDMF includes data on Butamben's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Butamben USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Butamben 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 Butamben Drug Master File in Japan (Butamben JDMF) empowers Butamben 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 Butamben JDMF during the approval evaluation for pharmaceutical products. At the time of Butamben 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 Butamben suppliers with JDMF on PharmaCompass.
Butamben 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 Butamben 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 Butamben GMP manufacturer or Butamben GMP API supplier for your needs.
A Butamben CoA (Certificate of Analysis) is a formal document that attests to Butamben's compliance with Butamben specifications and serves as a tool for batch-level quality control.
Butamben CoA mostly includes findings from lab analyses of a specific batch. For each Butamben 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.
Butamben may be tested according to a variety of international standards, such as European Pharmacopoeia (Butamben EP), Butamben JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Butamben USP).
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