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