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