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API SUPPLIERS
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USDMF
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DOSAGE - CREAM;TOPICAL - 10%
USFDA APPLICATION NUMBER - 6927
DOSAGE - LOTION;TOPICAL - 10%
USFDA APPLICATION NUMBER - 9112
Related Excipient Companies
SPI Pharma
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Crotamiton 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 Crotamiton manufacturer or Crotamiton supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Crotamiton manufacturer or Crotamiton supplier.
PharmaCompass also assists you with knowing the Crotamiton API Price utilized in the formulation of products. Crotamiton API Price is not always fixed or binding as the Crotamiton Price is obtained through a variety of data sources. The Crotamiton Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Crotamiton manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Crotamiton, including repackagers and relabelers. The FDA regulates Crotamiton manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Crotamiton 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 Crotamiton manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Crotamiton supplier is an individual or a company that provides Crotamiton active pharmaceutical ingredient (API) or Crotamiton finished formulations upon request. The Crotamiton suppliers may include Crotamiton API manufacturers, exporters, distributors and traders.
click here to find a list of Crotamiton suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Crotamiton DMF (Drug Master File) is a document detailing the whole manufacturing process of Crotamiton active pharmaceutical ingredient (API) in detail. Different forms of Crotamiton DMFs exist exist since differing nations have different regulations, such as Crotamiton USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Crotamiton DMF submitted to regulatory agencies in the US is known as a USDMF. Crotamiton USDMF includes data on Crotamiton's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Crotamiton USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Crotamiton 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 Crotamiton Drug Master File in Japan (Crotamiton JDMF) empowers Crotamiton 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 Crotamiton JDMF during the approval evaluation for pharmaceutical products. At the time of Crotamiton 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 Crotamiton 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 Crotamiton Drug Master File in Korea (Crotamiton KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Crotamiton. The MFDS reviews the Crotamiton KDMF as part of the drug registration process and uses the information provided in the Crotamiton KDMF to evaluate the safety and efficacy of the drug.
After submitting a Crotamiton 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 Crotamiton API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Crotamiton suppliers with KDMF on PharmaCompass.
A Crotamiton CEP of the European Pharmacopoeia monograph is often referred to as a Crotamiton Certificate of Suitability (COS). The purpose of a Crotamiton CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Crotamiton EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Crotamiton to their clients by showing that a Crotamiton CEP has been issued for it. The manufacturer submits a Crotamiton CEP (COS) as part of the market authorization procedure, and it takes on the role of a Crotamiton CEP holder for the record. Additionally, the data presented in the Crotamiton CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Crotamiton DMF.
A Crotamiton CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Crotamiton 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 Crotamiton suppliers with CEP (COS) on PharmaCompass.
A Crotamiton written confirmation (Crotamiton WC) is an official document issued by a regulatory agency to a Crotamiton manufacturer, verifying that the manufacturing facility of a Crotamiton active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Crotamiton APIs or Crotamiton finished pharmaceutical products to another nation, regulatory agencies frequently require a Crotamiton WC (written confirmation) as part of the regulatory process.
click here to find a list of Crotamiton suppliers with Written Confirmation (WC) on PharmaCompass.
Crotamiton 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 Crotamiton 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 Crotamiton GMP manufacturer or Crotamiton GMP API supplier for your needs.
A Crotamiton CoA (Certificate of Analysis) is a formal document that attests to Crotamiton's compliance with Crotamiton specifications and serves as a tool for batch-level quality control.
Crotamiton CoA mostly includes findings from lab analyses of a specific batch. For each Crotamiton 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.
Crotamiton may be tested according to a variety of international standards, such as European Pharmacopoeia (Crotamiton EP), Crotamiton JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Crotamiton USP).
