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API SUPPLIERS
Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.
TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DOSAGE - CREAM;TOPICAL - 10%
USFDA APPLICATION NUMBER - 6927
DOSAGE - LOTION;TOPICAL - 10%
USFDA APPLICATION NUMBER - 9112
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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 Crotamitone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Crotamitone, including repackagers and relabelers. The FDA regulates Crotamitone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Crotamitone 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 Crotamitone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Crotamitone supplier is an individual or a company that provides Crotamitone active pharmaceutical ingredient (API) or Crotamitone finished formulations upon request. The Crotamitone suppliers may include Crotamitone API manufacturers, exporters, distributors and traders.
click here to find a list of Crotamitone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Crotamitone DMF (Drug Master File) is a document detailing the whole manufacturing process of Crotamitone active pharmaceutical ingredient (API) in detail. Different forms of Crotamitone DMFs exist exist since differing nations have different regulations, such as Crotamitone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Crotamitone DMF submitted to regulatory agencies in the US is known as a USDMF. Crotamitone USDMF includes data on Crotamitone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Crotamitone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Crotamitone 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 Crotamitone Drug Master File in Japan (Crotamitone JDMF) empowers Crotamitone 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 Crotamitone JDMF during the approval evaluation for pharmaceutical products. At the time of Crotamitone 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 Crotamitone 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 Crotamitone Drug Master File in Korea (Crotamitone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Crotamitone. The MFDS reviews the Crotamitone KDMF as part of the drug registration process and uses the information provided in the Crotamitone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Crotamitone 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 Crotamitone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Crotamitone suppliers with KDMF on PharmaCompass.
A Crotamitone CEP of the European Pharmacopoeia monograph is often referred to as a Crotamitone Certificate of Suitability (COS). The purpose of a Crotamitone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Crotamitone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Crotamitone to their clients by showing that a Crotamitone CEP has been issued for it. The manufacturer submits a Crotamitone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Crotamitone CEP holder for the record. Additionally, the data presented in the Crotamitone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Crotamitone DMF.
A Crotamitone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Crotamitone 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 Crotamitone suppliers with CEP (COS) on PharmaCompass.
A Crotamitone written confirmation (Crotamitone WC) is an official document issued by a regulatory agency to a Crotamitone manufacturer, verifying that the manufacturing facility of a Crotamitone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Crotamitone APIs or Crotamitone finished pharmaceutical products to another nation, regulatory agencies frequently require a Crotamitone WC (written confirmation) as part of the regulatory process.
click here to find a list of Crotamitone suppliers with Written Confirmation (WC) on PharmaCompass.
Crotamitone 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 Crotamitone 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 Crotamitone GMP manufacturer or Crotamitone GMP API supplier for your needs.
A Crotamitone CoA (Certificate of Analysis) is a formal document that attests to Crotamitone's compliance with Crotamitone specifications and serves as a tool for batch-level quality control.
Crotamitone CoA mostly includes findings from lab analyses of a specific batch. For each Crotamitone 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.
Crotamitone may be tested according to a variety of international standards, such as European Pharmacopoeia (Crotamitone EP), Crotamitone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Crotamitone USP).
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