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