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